EULAR (European League Against Rheumatism): 2014 Congress

PARIS – Cranial ultrasound was more sensitive and just as specific as was temporal artery biopsy for the diagnosis of giant cell arteritis, based on the results of a retrospective cohort study reported by Dr. Adam Croft at a press conference held during the annual European Congress of Rheumatology.

Given that ultrasound is noninvasive, associated with fewer risks, and more sensitive than biopsy, "temporal artery biopsy may now be unnecessary (when) clinical suspicion of GCA [giant cell arteritis] is high or quite low," said Dr. Croft of the University of Birmingham, England. "Cranial ultrasound may soon replace temporal artery biopsy in the assessment of patients with a suspected diagnosis of GCA in routine clinical practice."

Giant cell arteritis typically is associated with severe headaches and scalp tenderness on the sides of the forehead that must be distinguished from more benign causes of headache. In GCA, these symptoms result from ocular arterial inflammation and narrowing that respond to high-dose steroid therapy.

The findings were seen in a study of 87 patients who underwent cranial duplex ultrasound for suspected GCA. At 3-month follow-up, 36 patients (41%) had a confirmed clinical diagnosis of giant cell arteritis. Of the 30 patients with a positive cranial ultrasound result, 29 went on to have a confirmed diagnosis. Of the 36 patients with more than three American College of Rheumatology criteria, 21 (58%) had a diagnosis of GCA.

When compared with clinical diagnosis, ultrasound had 81% sensitivity and 98% specificity with a positive likelihood ratio of 41 and a negative likelihood ratio 0.2. The positive predictive value was 97% and the negative predictive value was 88%, he said. In other words, with a positive ultrasound finding, the probability of giant cell arteritis was 41 times higher.

In contrast, when compared with clinical diagnosis, temporal artery biopsy had a sensitivity of 53% and a specificity of 100%. The positive likelihood ratio was 2.3 and the negative likelihood ratio 0.2. The positive predictive value was 100% and the negative predictive value was 47%.

Relying on temporal arterial biopsy results alone leaves "patients at risk of missing out on potentially sight-saving steroid treatment, or of being treated with high-dose steroids unnecessarily," he said. Further, temporal artery biopsy is not without risks. The biopsy can miss the artery and can result is permanent facial nerve damage. A negative biopsy rarely informs practice.

The availability of cranial ultrasound depends on whether one’s practice is located near facilities with the infrastructure and the availability of well-trained rheumatologists and radiologists who can do the scan rapidly, Dr. Croft said in a video interview.

Dr. Croft had no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter @maryjodales

PARIS – Cranial ultrasound was more sensitive and just as specific as was temporal artery biopsy for the diagnosis of giant cell arteritis, based on the results of a retrospective cohort study reported by Dr. Adam Croft at a press conference held during the annual European Congress of Rheumatology.

Given that ultrasound is noninvasive, associated with fewer risks, and more sensitive than biopsy, "temporal artery biopsy may now be unnecessary (when) clinical suspicion of GCA [giant cell arteritis] is high or quite low," said Dr. Croft of the University of Birmingham, England. "Cranial ultrasound may soon replace temporal artery biopsy in the assessment of patients with a suspected diagnosis of GCA in routine clinical practice."

Giant cell arteritis typically is associated with severe headaches and scalp tenderness on the sides of the forehead that must be distinguished from more benign causes of headache. In GCA, these symptoms result from ocular arterial inflammation and narrowing that respond to high-dose steroid therapy.

The findings were seen in a study of 87 patients who underwent cranial duplex ultrasound for suspected GCA. At 3-month follow-up, 36 patients (41%) had a confirmed clinical diagnosis of giant cell arteritis. Of the 30 patients with a positive cranial ultrasound result, 29 went on to have a confirmed diagnosis. Of the 36 patients with more than three American College of Rheumatology criteria, 21 (58%) had a diagnosis of GCA.

When compared with clinical diagnosis, ultrasound had 81% sensitivity and 98% specificity with a positive likelihood ratio of 41 and a negative likelihood ratio 0.2. The positive predictive value was 97% and the negative predictive value was 88%, he said. In other words, with a positive ultrasound finding, the probability of giant cell arteritis was 41 times higher.

In contrast, when compared with clinical diagnosis, temporal artery biopsy had a sensitivity of 53% and a specificity of 100%. The positive likelihood ratio was 2.3 and the negative likelihood ratio 0.2. The positive predictive value was 100% and the negative predictive value was 47%.

Relying on temporal arterial biopsy results alone leaves "patients at risk of missing out on potentially sight-saving steroid treatment, or of being treated with high-dose steroids unnecessarily," he said. Further, temporal artery biopsy is not without risks. The biopsy can miss the artery and can result is permanent facial nerve damage. A negative biopsy rarely informs practice.

The availability of cranial ultrasound depends on whether one’s practice is located near facilities with the infrastructure and the availability of well-trained rheumatologists and radiologists who can do the scan rapidly, Dr. Croft said in a video interview.

Dr. Croft had no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter @maryjodales

PARIS – Cranial ultrasound was more sensitive and just as specific as was temporal artery biopsy for the diagnosis of giant cell arteritis, based on the results of a retrospective cohort study reported by Dr. Adam Croft at a press conference held during the annual European Congress of Rheumatology.

Given that ultrasound is noninvasive, associated with fewer risks, and more sensitive than biopsy, "temporal artery biopsy may now be unnecessary (when) clinical suspicion of GCA [giant cell arteritis] is high or quite low," said Dr. Croft of the University of Birmingham, England. "Cranial ultrasound may soon replace temporal artery biopsy in the assessment of patients with a suspected diagnosis of GCA in routine clinical practice."

Giant cell arteritis typically is associated with severe headaches and scalp tenderness on the sides of the forehead that must be distinguished from more benign causes of headache. In GCA, these symptoms result from ocular arterial inflammation and narrowing that respond to high-dose steroid therapy.

The findings were seen in a study of 87 patients who underwent cranial duplex ultrasound for suspected GCA. At 3-month follow-up, 36 patients (41%) had a confirmed clinical diagnosis of giant cell arteritis. Of the 30 patients with a positive cranial ultrasound result, 29 went on to have a confirmed diagnosis. Of the 36 patients with more than three American College of Rheumatology criteria, 21 (58%) had a diagnosis of GCA.

When compared with clinical diagnosis, ultrasound had 81% sensitivity and 98% specificity with a positive likelihood ratio of 41 and a negative likelihood ratio 0.2. The positive predictive value was 97% and the negative predictive value was 88%, he said. In other words, with a positive ultrasound finding, the probability of giant cell arteritis was 41 times higher.

In contrast, when compared with clinical diagnosis, temporal artery biopsy had a sensitivity of 53% and a specificity of 100%. The positive likelihood ratio was 2.3 and the negative likelihood ratio 0.2. The positive predictive value was 100% and the negative predictive value was 47%.

Relying on temporal arterial biopsy results alone leaves "patients at risk of missing out on potentially sight-saving steroid treatment, or of being treated with high-dose steroids unnecessarily," he said. Further, temporal artery biopsy is not without risks. The biopsy can miss the artery and can result is permanent facial nerve damage. A negative biopsy rarely informs practice.

The availability of cranial ultrasound depends on whether one’s practice is located near facilities with the infrastructure and the availability of well-trained rheumatologists and radiologists who can do the scan rapidly, Dr. Croft said in a video interview.

Dr. Croft had no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter @maryjodales

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.

PARIS – Three micro RNAs have been shown to be associated with disease severity in patients with hip or knee osteoarthritis, based on data from a large population-based cohort in Italy*.

The presence of three specific miRNAs are biomarkers that might prove to be useful for predicting OA severity if validated in other cohorts and diverse populations of OA patients, Dr. Christian Beyer reported at a press conference during the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2013-204698]).

Mary Jo M. Dales/Frontline Medical News

The miRNAs could also be a first step toward finding new OA therapies, such as approaches that avert cartilage loss, said Dr. Beyer of the University of Erlangen–Nuremberg (Germany).

For the study, serum samples from 816 cohort members who had osteoarthritis and were followed for at least 15 years were analyzed for the presence of any of the 374 miRNAs. A microarray screening identified 12 candidate miRNAs, validated in the entire cohort. Based on a regression analysis, the 67 cohort members who went on to have knee or hip arthroplasty were found to differentially express three of the miRNAs: let-7e, miR-454, and miR-885-5p. The most promising of the markers appears to be let-7e.

Let-7e was a negative predictor for total joint arthroplasty with an adjusted hazard ratio of 0.75 (95% confidence interval, 0.58-0.96; P = .021) when normalized to U6, and 0.76 (95% CI, 0.6-0.97; P = .026) after normalization to the Ct-average. However, miR-454 was inversely correlated with severe knee or hip osteoarthritis with an adjusted HR of 0.77 (95% CI, 0.61-0.97; P = .028) when normalized to U6. This correlation was lost when data were normalized to Ct-average (P = .118). Finally, miR-885-5p showed a trend toward a positive relationship with arthroplasty when normalized to U6 (HR, 1.24; 95% CI, 0.95-1.62; P = .107) or to Ct-average (HR, 1.30; 95% CI, 0.99-1.70; P = .056).

If specific miRNAs prove to be biomarkers to predict OA severity, it would offer the ability to use markers that are found in the peripheral circulation, stable over time, and not sex dependent. Such markers also could prove useful for finding new OA therapies, he said.

Next steps for further study include validation of the miRNA biomarkers in other OA cohorts, Dr. Beyer said. The well-defined Bruneck cohort is a stable community that has been extensively studied similar to the Framingham cohort in the United States. The Bruneck cohort is all white, however, and the results of this study need to be validated in diverse populations.

Dr. Beyer declared having no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter@maryjodales

CORRECTION, 6/12/2014: An earlier version of the article misstated the location of the study cohort.

PARIS – Three micro RNAs have been shown to be associated with disease severity in patients with hip or knee osteoarthritis, based on data from a large population-based cohort in Italy*.

The presence of three specific miRNAs are biomarkers that might prove to be useful for predicting OA severity if validated in other cohorts and diverse populations of OA patients, Dr. Christian Beyer reported at a press conference during the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2013-204698]).

Mary Jo M. Dales/Frontline Medical News

The miRNAs could also be a first step toward finding new OA therapies, such as approaches that avert cartilage loss, said Dr. Beyer of the University of Erlangen–Nuremberg (Germany).

For the study, serum samples from 816 cohort members who had osteoarthritis and were followed for at least 15 years were analyzed for the presence of any of the 374 miRNAs. A microarray screening identified 12 candidate miRNAs, validated in the entire cohort. Based on a regression analysis, the 67 cohort members who went on to have knee or hip arthroplasty were found to differentially express three of the miRNAs: let-7e, miR-454, and miR-885-5p. The most promising of the markers appears to be let-7e.

Let-7e was a negative predictor for total joint arthroplasty with an adjusted hazard ratio of 0.75 (95% confidence interval, 0.58-0.96; P = .021) when normalized to U6, and 0.76 (95% CI, 0.6-0.97; P = .026) after normalization to the Ct-average. However, miR-454 was inversely correlated with severe knee or hip osteoarthritis with an adjusted HR of 0.77 (95% CI, 0.61-0.97; P = .028) when normalized to U6. This correlation was lost when data were normalized to Ct-average (P = .118). Finally, miR-885-5p showed a trend toward a positive relationship with arthroplasty when normalized to U6 (HR, 1.24; 95% CI, 0.95-1.62; P = .107) or to Ct-average (HR, 1.30; 95% CI, 0.99-1.70; P = .056).

If specific miRNAs prove to be biomarkers to predict OA severity, it would offer the ability to use markers that are found in the peripheral circulation, stable over time, and not sex dependent. Such markers also could prove useful for finding new OA therapies, he said.

Next steps for further study include validation of the miRNA biomarkers in other OA cohorts, Dr. Beyer said. The well-defined Bruneck cohort is a stable community that has been extensively studied similar to the Framingham cohort in the United States. The Bruneck cohort is all white, however, and the results of this study need to be validated in diverse populations.

Dr. Beyer declared having no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter@maryjodales

CORRECTION, 6/12/2014: An earlier version of the article misstated the location of the study cohort.

PARIS – Three micro RNAs have been shown to be associated with disease severity in patients with hip or knee osteoarthritis, based on data from a large population-based cohort in Italy*.

The presence of three specific miRNAs are biomarkers that might prove to be useful for predicting OA severity if validated in other cohorts and diverse populations of OA patients, Dr. Christian Beyer reported at a press conference during the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2013-204698]).

Mary Jo M. Dales/Frontline Medical News

The miRNAs could also be a first step toward finding new OA therapies, such as approaches that avert cartilage loss, said Dr. Beyer of the University of Erlangen–Nuremberg (Germany).

For the study, serum samples from 816 cohort members who had osteoarthritis and were followed for at least 15 years were analyzed for the presence of any of the 374 miRNAs. A microarray screening identified 12 candidate miRNAs, validated in the entire cohort. Based on a regression analysis, the 67 cohort members who went on to have knee or hip arthroplasty were found to differentially express three of the miRNAs: let-7e, miR-454, and miR-885-5p. The most promising of the markers appears to be let-7e.

Let-7e was a negative predictor for total joint arthroplasty with an adjusted hazard ratio of 0.75 (95% confidence interval, 0.58-0.96; P = .021) when normalized to U6, and 0.76 (95% CI, 0.6-0.97; P = .026) after normalization to the Ct-average. However, miR-454 was inversely correlated with severe knee or hip osteoarthritis with an adjusted HR of 0.77 (95% CI, 0.61-0.97; P = .028) when normalized to U6. This correlation was lost when data were normalized to Ct-average (P = .118). Finally, miR-885-5p showed a trend toward a positive relationship with arthroplasty when normalized to U6 (HR, 1.24; 95% CI, 0.95-1.62; P = .107) or to Ct-average (HR, 1.30; 95% CI, 0.99-1.70; P = .056).

If specific miRNAs prove to be biomarkers to predict OA severity, it would offer the ability to use markers that are found in the peripheral circulation, stable over time, and not sex dependent. Such markers also could prove useful for finding new OA therapies, he said.

Next steps for further study include validation of the miRNA biomarkers in other OA cohorts, Dr. Beyer said. The well-defined Bruneck cohort is a stable community that has been extensively studied similar to the Framingham cohort in the United States. The Bruneck cohort is all white, however, and the results of this study need to be validated in diverse populations.

Dr. Beyer declared having no relevant financial disclosures.

mdales@frontlinemedcom.com

On Twitter@maryjodales

CORRECTION, 6/12/2014: An earlier version of the article misstated the location of the study cohort.

PARIS – Newly discovered micro RNA molecules found in the blood of patients before they developed severe osteoarthritis may help predict the disease and potentially identify those who would most benefit from preventive interventions.

That finding emerged from a longitudinal study presented at the annual European Congress of Rheumatology.

By using a screening technique to search a broad array of micro RNAs (miRNAs), Dr. Christian Beyer of the University of Erlangen-Nuremberg (Germany) and his colleagues found several miRNAs that were differentially expressed in the blood of 67 people who developed severe osteoarthritis and underwent at least one total joint replacement and 749 who did not.

One miRNA molecule in particular, known as let-7e, appeared to be "very promising" in this regard, he said. Let-7e is inversely associated with the development of osteoarthritis, with levels correlating with the risk of developing OA, Dr. Beyer said in a video interview with Dr. Christopher Sparks of the University of Liverpool (England).

jevans@frontlinemedcom.com

PARIS – Newly discovered micro RNA molecules found in the blood of patients before they developed severe osteoarthritis may help predict the disease and potentially identify those who would most benefit from preventive interventions.

That finding emerged from a longitudinal study presented at the annual European Congress of Rheumatology.

By using a screening technique to search a broad array of micro RNAs (miRNAs), Dr. Christian Beyer of the University of Erlangen-Nuremberg (Germany) and his colleagues found several miRNAs that were differentially expressed in the blood of 67 people who developed severe osteoarthritis and underwent at least one total joint replacement and 749 who did not.

One miRNA molecule in particular, known as let-7e, appeared to be "very promising" in this regard, he said. Let-7e is inversely associated with the development of osteoarthritis, with levels correlating with the risk of developing OA, Dr. Beyer said in a video interview with Dr. Christopher Sparks of the University of Liverpool (England).

jevans@frontlinemedcom.com

PARIS – Newly discovered micro RNA molecules found in the blood of patients before they developed severe osteoarthritis may help predict the disease and potentially identify those who would most benefit from preventive interventions.

That finding emerged from a longitudinal study presented at the annual European Congress of Rheumatology.

By using a screening technique to search a broad array of micro RNAs (miRNAs), Dr. Christian Beyer of the University of Erlangen-Nuremberg (Germany) and his colleagues found several miRNAs that were differentially expressed in the blood of 67 people who developed severe osteoarthritis and underwent at least one total joint replacement and 749 who did not.

One miRNA molecule in particular, known as let-7e, appeared to be "very promising" in this regard, he said. Let-7e is inversely associated with the development of osteoarthritis, with levels correlating with the risk of developing OA, Dr. Beyer said in a video interview with Dr. Christopher Sparks of the University of Liverpool (England).

jevans@frontlinemedcom.com

PARIS – New guidelines aim to narrow the wide variation that has been observed across specialties and countries in the treatment of patients with polymyalgia rheumatica.

The guidelines, the first ever developed in a joint collaboration between the American College of Rheumatology and the European League Against Rheumatism, brought together "probably the biggest and most diverse guidelines panel" ever assembled for a rheumatologic condition – with 51 members, including patients, according to Dr. Bhaskar Dasgupta, primary author of the guidelines and leader of the guidelines study group.

Within the guidelines is a flowchart for the treatment of polymyalgia rheumatica that outlines overarching principles for care involving clinical, laboratory, and imaging assessments, as well as patient views, said Dr. Dasgupta, head of the department of rheumatology at Southend University Hospital, Essex, England.

jevans@frontlinemedcom.com

PARIS – New guidelines aim to narrow the wide variation that has been observed across specialties and countries in the treatment of patients with polymyalgia rheumatica.

The guidelines, the first ever developed in a joint collaboration between the American College of Rheumatology and the European League Against Rheumatism, brought together "probably the biggest and most diverse guidelines panel" ever assembled for a rheumatologic condition – with 51 members, including patients, according to Dr. Bhaskar Dasgupta, primary author of the guidelines and leader of the guidelines study group.

Within the guidelines is a flowchart for the treatment of polymyalgia rheumatica that outlines overarching principles for care involving clinical, laboratory, and imaging assessments, as well as patient views, said Dr. Dasgupta, head of the department of rheumatology at Southend University Hospital, Essex, England.

jevans@frontlinemedcom.com

PARIS – New guidelines aim to narrow the wide variation that has been observed across specialties and countries in the treatment of patients with polymyalgia rheumatica.

The guidelines, the first ever developed in a joint collaboration between the American College of Rheumatology and the European League Against Rheumatism, brought together "probably the biggest and most diverse guidelines panel" ever assembled for a rheumatologic condition – with 51 members, including patients, according to Dr. Bhaskar Dasgupta, primary author of the guidelines and leader of the guidelines study group.

Within the guidelines is a flowchart for the treatment of polymyalgia rheumatica that outlines overarching principles for care involving clinical, laboratory, and imaging assessments, as well as patient views, said Dr. Dasgupta, head of the department of rheumatology at Southend University Hospital, Essex, England.

jevans@frontlinemedcom.com

*PARIS - Two different biosimilar drugs, one a mimic of infliximab, the other modeled on etanercept, closely matched the efficacy and safety of their brand-name counterparts in a pair of separate, randomized, controlled studies.

In one study, treatment with infliximab and a biosimilar agent showed virtually identical efficacy and safety performance at several time points during the first 16 weeks of treatment of 189 patients with rheumatoid arthritis in a head-to-head, randomized comparison done at 23 centers in India.

In the second study, an agent produced to match etanercept showed very similar efficacy and safety to the branded formulation in a total of 233 randomized patients treated for 24 weeks at several centers in Korea.

The second study run in India was the "first clinical trial of a biosimilar infliximab to demonstrate and report kinetics of response to treatment at multiple time points prior to the plateau phase," which starts at about weeks 16, Dr. Jonathan Kay said at the annual European Congress of Rheumatology. It provides "convincing evidence of therapeutic equivalence," and also serves as a "new paradigm for comparative effectiveness testing of biosimilars," said Dr. Kay, a professor of medicine at the University of Massachusetts in Worcester.

Dr. Kay and his colleagues randomized 62 patients with active rheumatoid arthritis (RA) on stable doses of methotrexate to infliximab (Remicade) and 127 patients to BOW015, the biosimilar under study. They measured the proportion of responders at 2, 6, 14, and 16 weeks, with the study’s primary endpoint the percentage of patients showing an American College of Rheumatology 20 (ACR20) response at 16 weeks. The proportion of responders at each of these four time points was virtually identical, Dr. Kay reported. At 16 weeks, the percent of ACR20 responders was 86% in the infliximab arm and 90% in the biosimilar arm. The percent of ACR50 and ACR70 responders was also virtually the same in both treatment arms at 16 weeks, and the percent of ACR20 responders was virtually identical in the two treatment arms at weeks 2, 6, and 14.

The safety profiles of the two drugs also showed no statistically significant differences for any parameter measured except for the incidence of skin disorders, which occurred in one patient treated with the biosimilar and four patients treated with infliximab, a statistically significant difference.

At the same session, Dr. Sang-Cheol Bae of the Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, presented findings from a randomized, controlled trial that compared the etanercept biosimilar HD203 with etanercept (Enbrel). Dr. Bae and his colleagues randomized 115 patients with active rheumatoid arthritis to HD203 and 118 patients to etanercept, both in combination with methotrexate, with the primary endpoint set as the proportion of patients achieving ACR20 by week 24. No statistically significant differences were seen between the patient groups for this primary endpoint, and equivalence in efficacy was demonstrated within predefined margins. The percent of ACR20 responders at 24 weeks was 79% in the biosimilar arm and 76% with etanercept.

Secondary analyses showed that the ACR50 responses occurred in 65% of the patients on the biosimilar at 24 weeks and in 53% of patients on etanercept, a statistically significant difference; and after 48 weeks of treatment, the ACR50 rate was 68% in the biosimilar arm and 55% with etanercept, also a statistically significant difference. The two study groups showed no significant difference in the rate of ACR70 responders after 24 or 48 weeks, and also no statistically significant difference in the rate of ACR20 responders after 48 weeks.

The results also showed that the biosimilar was "well tolerated," with a safety profile "comparable" with etanercept, Dr. Bae said.

Dr. Kay has received research funding and/or consulting income from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Epirus, Genentech, Hospira, Janssen, Pfizer, Roche, and UCB. Dr. Bae acknowledged receiving consulting income and/or research support from Abbott, Bristol-Myers Squibb, Eisai, GlaxoSmithKline, Hanwha Chemical, Merck Serono, MSD, and Pfizer.

 * This story was updated 6/13/14.

*PARIS - Two different biosimilar drugs, one a mimic of infliximab, the other modeled on etanercept, closely matched the efficacy and safety of their brand-name counterparts in a pair of separate, randomized, controlled studies.

In one study, treatment with infliximab and a biosimilar agent showed virtually identical efficacy and safety performance at several time points during the first 16 weeks of treatment of 189 patients with rheumatoid arthritis in a head-to-head, randomized comparison done at 23 centers in India.

In the second study, an agent produced to match etanercept showed very similar efficacy and safety to the branded formulation in a total of 233 randomized patients treated for 24 weeks at several centers in Korea.

The second study run in India was the "first clinical trial of a biosimilar infliximab to demonstrate and report kinetics of response to treatment at multiple time points prior to the plateau phase," which starts at about weeks 16, Dr. Jonathan Kay said at the annual European Congress of Rheumatology. It provides "convincing evidence of therapeutic equivalence," and also serves as a "new paradigm for comparative effectiveness testing of biosimilars," said Dr. Kay, a professor of medicine at the University of Massachusetts in Worcester.

Dr. Kay and his colleagues randomized 62 patients with active rheumatoid arthritis (RA) on stable doses of methotrexate to infliximab (Remicade) and 127 patients to BOW015, the biosimilar under study. They measured the proportion of responders at 2, 6, 14, and 16 weeks, with the study’s primary endpoint the percentage of patients showing an American College of Rheumatology 20 (ACR20) response at 16 weeks. The proportion of responders at each of these four time points was virtually identical, Dr. Kay reported. At 16 weeks, the percent of ACR20 responders was 86% in the infliximab arm and 90% in the biosimilar arm. The percent of ACR50 and ACR70 responders was also virtually the same in both treatment arms at 16 weeks, and the percent of ACR20 responders was virtually identical in the two treatment arms at weeks 2, 6, and 14.

The safety profiles of the two drugs also showed no statistically significant differences for any parameter measured except for the incidence of skin disorders, which occurred in one patient treated with the biosimilar and four patients treated with infliximab, a statistically significant difference.

At the same session, Dr. Sang-Cheol Bae of the Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, presented findings from a randomized, controlled trial that compared the etanercept biosimilar HD203 with etanercept (Enbrel). Dr. Bae and his colleagues randomized 115 patients with active rheumatoid arthritis to HD203 and 118 patients to etanercept, both in combination with methotrexate, with the primary endpoint set as the proportion of patients achieving ACR20 by week 24. No statistically significant differences were seen between the patient groups for this primary endpoint, and equivalence in efficacy was demonstrated within predefined margins. The percent of ACR20 responders at 24 weeks was 79% in the biosimilar arm and 76% with etanercept.

Secondary analyses showed that the ACR50 responses occurred in 65% of the patients on the biosimilar at 24 weeks and in 53% of patients on etanercept, a statistically significant difference; and after 48 weeks of treatment, the ACR50 rate was 68% in the biosimilar arm and 55% with etanercept, also a statistically significant difference. The two study groups showed no significant difference in the rate of ACR70 responders after 24 or 48 weeks, and also no statistically significant difference in the rate of ACR20 responders after 48 weeks.

The results also showed that the biosimilar was "well tolerated," with a safety profile "comparable" with etanercept, Dr. Bae said.

Dr. Kay has received research funding and/or consulting income from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Epirus, Genentech, Hospira, Janssen, Pfizer, Roche, and UCB. Dr. Bae acknowledged receiving consulting income and/or research support from Abbott, Bristol-Myers Squibb, Eisai, GlaxoSmithKline, Hanwha Chemical, Merck Serono, MSD, and Pfizer.

 * This story was updated 6/13/14.

*PARIS - Two different biosimilar drugs, one a mimic of infliximab, the other modeled on etanercept, closely matched the efficacy and safety of their brand-name counterparts in a pair of separate, randomized, controlled studies.

In one study, treatment with infliximab and a biosimilar agent showed virtually identical efficacy and safety performance at several time points during the first 16 weeks of treatment of 189 patients with rheumatoid arthritis in a head-to-head, randomized comparison done at 23 centers in India.

In the second study, an agent produced to match etanercept showed very similar efficacy and safety to the branded formulation in a total of 233 randomized patients treated for 24 weeks at several centers in Korea.

The second study run in India was the "first clinical trial of a biosimilar infliximab to demonstrate and report kinetics of response to treatment at multiple time points prior to the plateau phase," which starts at about weeks 16, Dr. Jonathan Kay said at the annual European Congress of Rheumatology. It provides "convincing evidence of therapeutic equivalence," and also serves as a "new paradigm for comparative effectiveness testing of biosimilars," said Dr. Kay, a professor of medicine at the University of Massachusetts in Worcester.

Dr. Kay and his colleagues randomized 62 patients with active rheumatoid arthritis (RA) on stable doses of methotrexate to infliximab (Remicade) and 127 patients to BOW015, the biosimilar under study. They measured the proportion of responders at 2, 6, 14, and 16 weeks, with the study’s primary endpoint the percentage of patients showing an American College of Rheumatology 20 (ACR20) response at 16 weeks. The proportion of responders at each of these four time points was virtually identical, Dr. Kay reported. At 16 weeks, the percent of ACR20 responders was 86% in the infliximab arm and 90% in the biosimilar arm. The percent of ACR50 and ACR70 responders was also virtually the same in both treatment arms at 16 weeks, and the percent of ACR20 responders was virtually identical in the two treatment arms at weeks 2, 6, and 14.

The safety profiles of the two drugs also showed no statistically significant differences for any parameter measured except for the incidence of skin disorders, which occurred in one patient treated with the biosimilar and four patients treated with infliximab, a statistically significant difference.

At the same session, Dr. Sang-Cheol Bae of the Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, presented findings from a randomized, controlled trial that compared the etanercept biosimilar HD203 with etanercept (Enbrel). Dr. Bae and his colleagues randomized 115 patients with active rheumatoid arthritis to HD203 and 118 patients to etanercept, both in combination with methotrexate, with the primary endpoint set as the proportion of patients achieving ACR20 by week 24. No statistically significant differences were seen between the patient groups for this primary endpoint, and equivalence in efficacy was demonstrated within predefined margins. The percent of ACR20 responders at 24 weeks was 79% in the biosimilar arm and 76% with etanercept.

Secondary analyses showed that the ACR50 responses occurred in 65% of the patients on the biosimilar at 24 weeks and in 53% of patients on etanercept, a statistically significant difference; and after 48 weeks of treatment, the ACR50 rate was 68% in the biosimilar arm and 55% with etanercept, also a statistically significant difference. The two study groups showed no significant difference in the rate of ACR70 responders after 24 or 48 weeks, and also no statistically significant difference in the rate of ACR20 responders after 48 weeks.

The results also showed that the biosimilar was "well tolerated," with a safety profile "comparable" with etanercept, Dr. Bae said.

Dr. Kay has received research funding and/or consulting income from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Epirus, Genentech, Hospira, Janssen, Pfizer, Roche, and UCB. Dr. Bae acknowledged receiving consulting income and/or research support from Abbott, Bristol-Myers Squibb, Eisai, GlaxoSmithKline, Hanwha Chemical, Merck Serono, MSD, and Pfizer.

 * This story was updated 6/13/14.