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TNF inhibitors’ effect on ankylosing spondylitis progression may be greatest after 6 years

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The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.

The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.

feellife/Thinkstock
radiograph of ankylosing spondylitis
The radiographs were scored by two readers blinded to patient characteristics and also were randomized with radiographs from patients with ankylosing spondylitis who had not taken TNF-alpha inhibitors during the 8-year period (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23097).

In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.

Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.

Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.

“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”

In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.

“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.

The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.

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The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.

The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.

feellife/Thinkstock
radiograph of ankylosing spondylitis
The radiographs were scored by two readers blinded to patient characteristics and also were randomized with radiographs from patients with ankylosing spondylitis who had not taken TNF-alpha inhibitors during the 8-year period (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23097).

In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.

Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.

Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.

“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”

In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.

“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.

The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.

 

The benefits of treatment with TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis became most evident 6-8 years after the biologic therapy was initiated, according to findings from a prospective observational cohort study.

The study enrolled 210 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort who initiated treatment with TNF-alpha inhibitors during 2004-2012 and who received baseline and biannual radiographs over the 8-year follow-up.

feellife/Thinkstock
radiograph of ankylosing spondylitis
The radiographs were scored by two readers blinded to patient characteristics and also were randomized with radiographs from patients with ankylosing spondylitis who had not taken TNF-alpha inhibitors during the 8-year period (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23097).

In patients with complete modified Stoke AS Spine Score (mSASSS) data over 8 years of follow-up, the estimated mean spinal radiographic progression was 2.3 points during the first 2 years of treatment and then declined steadily to 1.4 in years 2-4, 1.0 in years 4-6 and 0.8 in years 6-8. This decrease was seen even after adjusting for baseline mSASSS, the presence of syndesmophytes, sex, HLA-B27 status, age, symptom duration, smoking duration, body mass index, disease activity, and NSAID use.

Patients with longer follow-up also showed more use of NSAIDs, higher C-reactive protein levels, and more spinal radiographic damage at baseline. There were, however, significant improvements in all disease activity measures as soon as patients began treatment, and patients also showed a rapid decrease in NSAID use over time, said Fiona Maas of the University Medical Center Groningen (Netherlands) and her associates.

Multiple studies have been conducted into the impact of TNF-alpha inhibitors on spinal radiographic progression in ankylosing spondylitis, but the results have been subject to some debate, the investigators noted.

“It is known that radiographic progression in AS is overall slow and highly variable between patients,” they wrote. “Therefore, differences in patient numbers at the different time points during follow-up can affect the outcome measure of interest, in this case radiographic progression.”

In this study, researchers saw a straightforward linear progression of disease in the first 4 years after treatment was initiated but a deflection from linear progression in years 6 and 8.

“These results may refer to a delayed effect of TNF-alpha inhibitors on radiographic progression and support the TNF brake hypothesis,” they wrote, suggesting that the long-term inhibition of inflammation with TNF-alpha inhibitors diminishes new bone formation over time in patients with longstanding disease.

The GLAS cohort was supported Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies including Pfizer. No other conflicts of interest were declared.

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Key clinical point: The benefits of TNF-alpha inhibitors in reducing spinal radiographic progression in ankylosing spondylitis become most evident 6-8 years after treatment initiation.

Major finding: Spinal radiographic progression rates on the modified Stoke AS Spine Score in ankylosing spondylitis patients treated with TNF-alpha inhibitors dropped from 2.3 during the first 2 years of treatment to 0.8 in years 6-8 after treatment initiation.

Data source: The Groningen Leeuwarden AS (GLAS) prospective observational cohort study involving 210 patients with ankylosing spondylitis.

Disclosures: The GLAS cohort was supported by Pfizer. Four authors declared research grants and consulting fees from pharmaceutical companies, including Pfizer. No other conflicts of interest were declared.

Most children with JIA get different diagnosis as adults

For many children, is JIA really something else?
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Tue, 02/07/2023 - 16:59

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

utah778/Thinkstock
“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

Body

 

This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

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Body

 

This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

Body

 

This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

Title
For many children, is JIA really something else?
For many children, is JIA really something else?

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

utah778/Thinkstock
“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

utah778/Thinkstock
“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

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Key clinical point: Most children with JIA are reclassified as having a different form of arthritis as adults.

Major finding: The childhood diagnosis of JIA is reclassified to another form of arthritis in two-thirds of patients in adulthood.

Data source: The Rheumatic Diseases Portuguese Register.

Disclosures: None of the authors had financial disclosures.

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Biosimilar version of etanercept gains FDA approval

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Biosimilar version of etanercept gains FDA approval

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

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A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

[email protected]

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Ankylosing spondylitis patients develop multiple comorbidities after diagnosis

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Ankylosing spondylitis patients develop multiple comorbidities after diagnosis

DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.

Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

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Dr. Jessica A. Walsh

“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.

Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.

During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.

Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.

A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.

“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”

Dr. Walsh is a consultant to AbbVie and Novartis.

[email protected]

On Twitter @mitchelzoler

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DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.

Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontine Medical News
Dr. Jessica A. Walsh

“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.

Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.

During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.

Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.

A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.

“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”

Dr. Walsh is a consultant to AbbVie and Novartis.

[email protected]

On Twitter @mitchelzoler

DENVER – Evidence continues to mount that ankylosing spondylitis patients are at increased risk for developing various comorbidities, compared with the general adult population.

Patients newly diagnosed with ankylosing spondylitis (AS) had twice the rate of new-onset depression during the first 3 years following diagnosis, compared with matched people from the general population in a study of more than 21,000 American adults. Patients with newly diagnosed AS also had a 60% higher rate of developing a new cardiovascular disease, compared with the matched general population, Jessica A. Walsh, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontine Medical News
Dr. Jessica A. Walsh

“We need to figure out what to do about all the comorbidities. Rheumatologists need to either screen their AS patients for comorbidities, or they need to be sure their patients are plugged in with another physician who will screen them,” said Dr. Walsh, director of the spondyloarthritis clinic at the University of Utah in Salt Lake City.

Her analysis used data from the Truven Health MarketScan databases for U.S. patients covered by Medicare or commercial health insurance, and included 6,370 patients with newly diagnosed AS and 14,988 adults matched by age and sex. The analysis only included AS patients who were free from comorbidities during the 2 years prior to their AS diagnosis. The average age of the people in the study was 52 years, and 54% were men.

During an average follow-up of 2.9 years following initial AS diagnosis, the most common comorbidity among the AS patients was uveitis, which occurred nearly 15-fold more frequently among the AS patients than in the controls. Other common incident comorbidities included inflammatory bowel disease, nearly sixfold more common among the AS patients, and osteoporosis, which was nearly threefold more common during follow-up after AS diagnosis, compared with the controls.

Other comorbidities with increased incidence in the AS patients included sleep apnea (80% more common among the AS patients during follow-up), asthma (50% more often), hypertension (44% more common), malignancy (23% more common), diabetes (20% more common), and dyslipidemia (11% more common). All these incidence rates represented statistically significant increases in the AS patients, compared with the controls.

A related analysis reported by Dr. Walsh also used data from the Truven Health databases for a somewhat larger group of AS patients, 6,679 followed for 1 year after their AS diagnosis, and 19,951 matched controls. The AS patients had a significantly higher rate of hospital admissions – 12%, compared with 6% among the controls – and a significantly higher rate of emergency department visits, at 23%, compared with 15% among the controls. The AS patients also had double the rate of physician office visits and prescribed medications.

“Obviously, the AS patients are not as healthy,” Dr. Walsh said in an interview. “We adjusted for their comorbidities, but that did not affect the hospitalization rates. We need to look into this more; I don’t know why the AS patients are being hospitalized. Typically AS itself does not lead to hospitalization, so I suspect it’s because of comorbidities, or perhaps because of adverse events from treatment.”

Dr. Walsh is a consultant to AbbVie and Novartis.

[email protected]

On Twitter @mitchelzoler

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Key clinical point: In the 3 years after initial ankylosing spondylitis diagnosis, the incidence of several comorbidities rises significantly above those in the general population.

Major finding: The incidence of new-onset depression among newly diagnosed ankylosing spondylitis patients was twice as high as it was among matched controls.

Data source: Observational data collected by Truven Health MarketScan, with a total of 21,358 patients and controls.

Disclosures: Dr. Walsh is a consultant to AbbVie and Novartis.

MRI now anchors spondyloarthritis diagnosis

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

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

Mitchel L. Zoler/Frontline Medical News
Dr. Walter P. Maksymowych

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @mitchelzoler

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

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

Mitchel L. Zoler/Frontline Medical News
Dr. Walter P. Maksymowych

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @mitchelzoler

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

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

Mitchel L. Zoler/Frontline Medical News
Dr. Walter P. Maksymowych

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

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

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

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

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

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

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

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

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

[email protected]

On Twitter @mitchelzoler

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Revised axial spondyloarthritis classification criteria remain elusive

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DENVER – The revised axial spondyloarthritis classification criteria that U.S. rheumatologists say they desperately need remain elusive, with no firm path to creation.

The 2009 classification criteria for axial spondyloarthritis (SpA) developed by the Assessment of Spondyloarthritis international Society (ASAS) was a landmark in creating a definition for axial SpA to use when enrolling patients into clinical trials and to also potentially use for diagnosis.

But the 2009 classification criteria also have several shortcomings, especially from a U.S. perspective, that have limited the utility of the criteria in U.S. practice and studies.

Mitchel L. Zoler/Frontline Medical News
Dr. Liron Caplan

Several years of discussions among North American rheumatologists about the classification criteria have produced consensus about what is wrong with them: The clinical elements of the criteria are not specific enough with sensitivity and specificity rates that are each about 80%-85%; the imaging component of the criteria is not totally up to date and as one example only considers osteitis and not other MRI abnormalities such as fatty metaplasia and T1 structural lesions; the criteria were entirely based on results from studies with Europeans, making their applicability to other patient types uncertain; and some terminology in the criteria are confusing, Liron Caplan, MD, said during a discussion of the criteria at the annual meeting of the of the Spondyloarthritis Research and Treatment Network.

But while the SpA experts who gathered at the meeting and who have also been discussing this issue since 2013 are of one mind on the problems, agreement on exactly how to solve them remains unresolved.

“Everything is still on the table,” said Dr. Caplan, a rheumatologist and director of the SpA program at the University of Colorado in Aurora.

A year ago, at SPARTAN’s prior annual meeting, circumstances looked on track for a quicker resolution. In a vote of the membership at the 2015 gathering, 64% backed creation of new classification criteria, and Dr. Caplan proposed quickly preparing a research proposal to present in early 2016 to the American College of Rheumatology and the European League Against Rheumatism for funding.

Mitchel L. Zoler/Frontline Medical News
Dr. Atul A. Deodhar

But in the ensuing year, the effort got mired in discussions on how to perform the study needed to gather the evidence base for criteria revisions. Some progress occurred, most notably an agreement between SPARTAN officials and the ASAS leadership to work together on the revision, said Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health & Science University in Portland.

The SPARTAN and ASAS representatives also agreed on several specifics of what’s needed, including a weighting formula for the 10 different clinical criteria of the SpA classification. Currently, in individuals with low back pain lasting 3 months or longer at an age of onset younger than 45 years, any one of these 10 clinical criteria can create a case of SpA either if combined with MRI or radiographic evidence of sacroiliitis, or without any imaging if the individual is HLA-B27 positive and fulfills two items from the 10-item list of clinical criteria.

It’s the lack of radiographic imaging confirmation, so-called “nonradiographic SpA,” that generates the greatest concern about below-par specificity and that may be helped by a weighting adjustment that varies the classification power of each of the 10 clinical items. A more ideal balance might be criteria with sensitivity reduced from the current level to about 70% and with specificity rising to about 90%, Dr. Caplan suggested.

The keystone of any revision will be a large, new study with SpA patients from various locations. Dr. Caplan emphasized that “no firm decisions have yet been made” regarding the study's name or research focus.

[email protected]

On Twitter @mitchelzoler

This article was updated August 11, 2016.

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DENVER – The revised axial spondyloarthritis classification criteria that U.S. rheumatologists say they desperately need remain elusive, with no firm path to creation.

The 2009 classification criteria for axial spondyloarthritis (SpA) developed by the Assessment of Spondyloarthritis international Society (ASAS) was a landmark in creating a definition for axial SpA to use when enrolling patients into clinical trials and to also potentially use for diagnosis.

But the 2009 classification criteria also have several shortcomings, especially from a U.S. perspective, that have limited the utility of the criteria in U.S. practice and studies.

Mitchel L. Zoler/Frontline Medical News
Dr. Liron Caplan

Several years of discussions among North American rheumatologists about the classification criteria have produced consensus about what is wrong with them: The clinical elements of the criteria are not specific enough with sensitivity and specificity rates that are each about 80%-85%; the imaging component of the criteria is not totally up to date and as one example only considers osteitis and not other MRI abnormalities such as fatty metaplasia and T1 structural lesions; the criteria were entirely based on results from studies with Europeans, making their applicability to other patient types uncertain; and some terminology in the criteria are confusing, Liron Caplan, MD, said during a discussion of the criteria at the annual meeting of the of the Spondyloarthritis Research and Treatment Network.

But while the SpA experts who gathered at the meeting and who have also been discussing this issue since 2013 are of one mind on the problems, agreement on exactly how to solve them remains unresolved.

“Everything is still on the table,” said Dr. Caplan, a rheumatologist and director of the SpA program at the University of Colorado in Aurora.

A year ago, at SPARTAN’s prior annual meeting, circumstances looked on track for a quicker resolution. In a vote of the membership at the 2015 gathering, 64% backed creation of new classification criteria, and Dr. Caplan proposed quickly preparing a research proposal to present in early 2016 to the American College of Rheumatology and the European League Against Rheumatism for funding.

Mitchel L. Zoler/Frontline Medical News
Dr. Atul A. Deodhar

But in the ensuing year, the effort got mired in discussions on how to perform the study needed to gather the evidence base for criteria revisions. Some progress occurred, most notably an agreement between SPARTAN officials and the ASAS leadership to work together on the revision, said Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health & Science University in Portland.

The SPARTAN and ASAS representatives also agreed on several specifics of what’s needed, including a weighting formula for the 10 different clinical criteria of the SpA classification. Currently, in individuals with low back pain lasting 3 months or longer at an age of onset younger than 45 years, any one of these 10 clinical criteria can create a case of SpA either if combined with MRI or radiographic evidence of sacroiliitis, or without any imaging if the individual is HLA-B27 positive and fulfills two items from the 10-item list of clinical criteria.

It’s the lack of radiographic imaging confirmation, so-called “nonradiographic SpA,” that generates the greatest concern about below-par specificity and that may be helped by a weighting adjustment that varies the classification power of each of the 10 clinical items. A more ideal balance might be criteria with sensitivity reduced from the current level to about 70% and with specificity rising to about 90%, Dr. Caplan suggested.

The keystone of any revision will be a large, new study with SpA patients from various locations. Dr. Caplan emphasized that “no firm decisions have yet been made” regarding the study's name or research focus.

[email protected]

On Twitter @mitchelzoler

This article was updated August 11, 2016.

DENVER – The revised axial spondyloarthritis classification criteria that U.S. rheumatologists say they desperately need remain elusive, with no firm path to creation.

The 2009 classification criteria for axial spondyloarthritis (SpA) developed by the Assessment of Spondyloarthritis international Society (ASAS) was a landmark in creating a definition for axial SpA to use when enrolling patients into clinical trials and to also potentially use for diagnosis.

But the 2009 classification criteria also have several shortcomings, especially from a U.S. perspective, that have limited the utility of the criteria in U.S. practice and studies.

Mitchel L. Zoler/Frontline Medical News
Dr. Liron Caplan

Several years of discussions among North American rheumatologists about the classification criteria have produced consensus about what is wrong with them: The clinical elements of the criteria are not specific enough with sensitivity and specificity rates that are each about 80%-85%; the imaging component of the criteria is not totally up to date and as one example only considers osteitis and not other MRI abnormalities such as fatty metaplasia and T1 structural lesions; the criteria were entirely based on results from studies with Europeans, making their applicability to other patient types uncertain; and some terminology in the criteria are confusing, Liron Caplan, MD, said during a discussion of the criteria at the annual meeting of the of the Spondyloarthritis Research and Treatment Network.

But while the SpA experts who gathered at the meeting and who have also been discussing this issue since 2013 are of one mind on the problems, agreement on exactly how to solve them remains unresolved.

“Everything is still on the table,” said Dr. Caplan, a rheumatologist and director of the SpA program at the University of Colorado in Aurora.

A year ago, at SPARTAN’s prior annual meeting, circumstances looked on track for a quicker resolution. In a vote of the membership at the 2015 gathering, 64% backed creation of new classification criteria, and Dr. Caplan proposed quickly preparing a research proposal to present in early 2016 to the American College of Rheumatology and the European League Against Rheumatism for funding.

Mitchel L. Zoler/Frontline Medical News
Dr. Atul A. Deodhar

But in the ensuing year, the effort got mired in discussions on how to perform the study needed to gather the evidence base for criteria revisions. Some progress occurred, most notably an agreement between SPARTAN officials and the ASAS leadership to work together on the revision, said Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health & Science University in Portland.

The SPARTAN and ASAS representatives also agreed on several specifics of what’s needed, including a weighting formula for the 10 different clinical criteria of the SpA classification. Currently, in individuals with low back pain lasting 3 months or longer at an age of onset younger than 45 years, any one of these 10 clinical criteria can create a case of SpA either if combined with MRI or radiographic evidence of sacroiliitis, or without any imaging if the individual is HLA-B27 positive and fulfills two items from the 10-item list of clinical criteria.

It’s the lack of radiographic imaging confirmation, so-called “nonradiographic SpA,” that generates the greatest concern about below-par specificity and that may be helped by a weighting adjustment that varies the classification power of each of the 10 clinical items. A more ideal balance might be criteria with sensitivity reduced from the current level to about 70% and with specificity rising to about 90%, Dr. Caplan suggested.

The keystone of any revision will be a large, new study with SpA patients from various locations. Dr. Caplan emphasized that “no firm decisions have yet been made” regarding the study's name or research focus.

[email protected]

On Twitter @mitchelzoler

This article was updated August 11, 2016.

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Concurrent fibromyalgia intensifies ankylosing spondylitis symptoms

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Concurrent fibromyalgia intensifies ankylosing spondylitis symptoms

DENVER – Fibromyalgia syndrome commonly occurred in patients with ankylosing spondylitis who were reviewed at one U.S. center, and when the two coexisted ankylosing spondylitis disease severity significantly increased.

In the study’s 62 patients with confirmed ankylosing spondylitis (AS), 27 (44%) also met the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, Sherilyn Diomampo, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network. The fibromyalgia rate in these AS patients was substantially above prior reports of fibromyalgia prevalence rates in the range of 10%-15%, said Dr. Diomampo, a rheumatologist at MetroHealth Medical Center in Cleveland.

Mitchel L. Zoler/Frontline Medical News
Dr. Sherilyn Diomampo

Patients with both disorders also had substantially higher scores across the board for all the measures of AS severity that Dr. Diomampo and her associates evaluated. For example, scores on the Bath AS Disease Activity Index averaged 6.8 in the patients with fibromyalgia and 3.8 in those without fibromyalgia. (A BASDAI score of 4.0 or higher generally suggests suboptimal disease control.) The average score of the AS Disease Activity Score using C-reactive protein (CRP) as the serum marker of inflammation was 4.2 in the subgroup with fibromyalgia and 2.8 in those without. (An ASDAS score of 3.5 or higher denotes high or very high disease activity. A score reduced by at least 1.1 indicates a clinically important improvement.) All these between-group differences were statistically significant.

Other measures of AS severity that were significantly higher with fibromyalgia included patient global self assessment, physician global assessment, average serum levels of CRP, and the average erythrocyte sedimentation rate.

The 2010 ACR diagnostic criteria for fibromyalgia syndrome used by Dr. Diomampo and her associates in their analysis require a patient to have a widespread pain index of at least 7 and symptom severity of at least 5, or alternatively, a widespread pain index of 3-6 and symptom severity of at least 9 (Arthritis Care Res. 2010 May;62[5]:600-10). In addition, for this study, the researchers stipulated that diagnosis of concomitant fibromyalgia meant patients had their fibromyalgia symptoms in place for at least 3 months, and the examining clinician could not attribute the patient’s pain to AS.

Using linear regression models with the widespread pain index and the symptom severity as the dependent variables, the researchers failed to see any statistically significant relationship between either of these two determinants of fibromyalgia severity and five different measures of AS severity, including the BASDAI and the ASDAS. In short, the assessment tools used to measure AS severity showed no ability to also measure the core characteristics of fibromyalgia, Dr. Diomampo said.

Overall, patients in the study averaged about 49 years old. The analysis showed a significantly higher rate of African-American patients in the fibromyalgia group, 63%, compared with a 37% rate of African Americans in those with AS and no fibromyalgia. The presence of acute, anterior uveitis was 27% among those with fibromyalgia and 73% of those with AS and no fibromyalgia. One notable similarity between the two subgroups was the percentage on treatment with a tumor necrosis factor inhibitor: 52% among those with concurrent fibromyalgia and 49% among those with AS alone.

Dr. Diomampo had no disclosures.

[email protected]

On Twitter @mitchelzoler

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DENVER – Fibromyalgia syndrome commonly occurred in patients with ankylosing spondylitis who were reviewed at one U.S. center, and when the two coexisted ankylosing spondylitis disease severity significantly increased.

In the study’s 62 patients with confirmed ankylosing spondylitis (AS), 27 (44%) also met the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, Sherilyn Diomampo, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network. The fibromyalgia rate in these AS patients was substantially above prior reports of fibromyalgia prevalence rates in the range of 10%-15%, said Dr. Diomampo, a rheumatologist at MetroHealth Medical Center in Cleveland.

Mitchel L. Zoler/Frontline Medical News
Dr. Sherilyn Diomampo

Patients with both disorders also had substantially higher scores across the board for all the measures of AS severity that Dr. Diomampo and her associates evaluated. For example, scores on the Bath AS Disease Activity Index averaged 6.8 in the patients with fibromyalgia and 3.8 in those without fibromyalgia. (A BASDAI score of 4.0 or higher generally suggests suboptimal disease control.) The average score of the AS Disease Activity Score using C-reactive protein (CRP) as the serum marker of inflammation was 4.2 in the subgroup with fibromyalgia and 2.8 in those without. (An ASDAS score of 3.5 or higher denotes high or very high disease activity. A score reduced by at least 1.1 indicates a clinically important improvement.) All these between-group differences were statistically significant.

Other measures of AS severity that were significantly higher with fibromyalgia included patient global self assessment, physician global assessment, average serum levels of CRP, and the average erythrocyte sedimentation rate.

The 2010 ACR diagnostic criteria for fibromyalgia syndrome used by Dr. Diomampo and her associates in their analysis require a patient to have a widespread pain index of at least 7 and symptom severity of at least 5, or alternatively, a widespread pain index of 3-6 and symptom severity of at least 9 (Arthritis Care Res. 2010 May;62[5]:600-10). In addition, for this study, the researchers stipulated that diagnosis of concomitant fibromyalgia meant patients had their fibromyalgia symptoms in place for at least 3 months, and the examining clinician could not attribute the patient’s pain to AS.

Using linear regression models with the widespread pain index and the symptom severity as the dependent variables, the researchers failed to see any statistically significant relationship between either of these two determinants of fibromyalgia severity and five different measures of AS severity, including the BASDAI and the ASDAS. In short, the assessment tools used to measure AS severity showed no ability to also measure the core characteristics of fibromyalgia, Dr. Diomampo said.

Overall, patients in the study averaged about 49 years old. The analysis showed a significantly higher rate of African-American patients in the fibromyalgia group, 63%, compared with a 37% rate of African Americans in those with AS and no fibromyalgia. The presence of acute, anterior uveitis was 27% among those with fibromyalgia and 73% of those with AS and no fibromyalgia. One notable similarity between the two subgroups was the percentage on treatment with a tumor necrosis factor inhibitor: 52% among those with concurrent fibromyalgia and 49% among those with AS alone.

Dr. Diomampo had no disclosures.

[email protected]

On Twitter @mitchelzoler

DENVER – Fibromyalgia syndrome commonly occurred in patients with ankylosing spondylitis who were reviewed at one U.S. center, and when the two coexisted ankylosing spondylitis disease severity significantly increased.

In the study’s 62 patients with confirmed ankylosing spondylitis (AS), 27 (44%) also met the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, Sherilyn Diomampo, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network. The fibromyalgia rate in these AS patients was substantially above prior reports of fibromyalgia prevalence rates in the range of 10%-15%, said Dr. Diomampo, a rheumatologist at MetroHealth Medical Center in Cleveland.

Mitchel L. Zoler/Frontline Medical News
Dr. Sherilyn Diomampo

Patients with both disorders also had substantially higher scores across the board for all the measures of AS severity that Dr. Diomampo and her associates evaluated. For example, scores on the Bath AS Disease Activity Index averaged 6.8 in the patients with fibromyalgia and 3.8 in those without fibromyalgia. (A BASDAI score of 4.0 or higher generally suggests suboptimal disease control.) The average score of the AS Disease Activity Score using C-reactive protein (CRP) as the serum marker of inflammation was 4.2 in the subgroup with fibromyalgia and 2.8 in those without. (An ASDAS score of 3.5 or higher denotes high or very high disease activity. A score reduced by at least 1.1 indicates a clinically important improvement.) All these between-group differences were statistically significant.

Other measures of AS severity that were significantly higher with fibromyalgia included patient global self assessment, physician global assessment, average serum levels of CRP, and the average erythrocyte sedimentation rate.

The 2010 ACR diagnostic criteria for fibromyalgia syndrome used by Dr. Diomampo and her associates in their analysis require a patient to have a widespread pain index of at least 7 and symptom severity of at least 5, or alternatively, a widespread pain index of 3-6 and symptom severity of at least 9 (Arthritis Care Res. 2010 May;62[5]:600-10). In addition, for this study, the researchers stipulated that diagnosis of concomitant fibromyalgia meant patients had their fibromyalgia symptoms in place for at least 3 months, and the examining clinician could not attribute the patient’s pain to AS.

Using linear regression models with the widespread pain index and the symptom severity as the dependent variables, the researchers failed to see any statistically significant relationship between either of these two determinants of fibromyalgia severity and five different measures of AS severity, including the BASDAI and the ASDAS. In short, the assessment tools used to measure AS severity showed no ability to also measure the core characteristics of fibromyalgia, Dr. Diomampo said.

Overall, patients in the study averaged about 49 years old. The analysis showed a significantly higher rate of African-American patients in the fibromyalgia group, 63%, compared with a 37% rate of African Americans in those with AS and no fibromyalgia. The presence of acute, anterior uveitis was 27% among those with fibromyalgia and 73% of those with AS and no fibromyalgia. One notable similarity between the two subgroups was the percentage on treatment with a tumor necrosis factor inhibitor: 52% among those with concurrent fibromyalgia and 49% among those with AS alone.

Dr. Diomampo had no disclosures.

[email protected]

On Twitter @mitchelzoler

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Concurrent fibromyalgia intensifies ankylosing spondylitis symptoms
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AT THE 2016 SPARTAN ANNUAL MEETING

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Key clinical point: Nearly half of patients with ankylosing spondylitis had concurrent fibromyalgia at one U.S. center, and patients with both had much greater AS severity.

Major finding: The average BASDAI was 6.8 in patients with ankylosing spondylitis and fibromyalgia and 3.8 in patients with AS only.

Data source: Observational data collected on 62 adults with ankylosing spondylitis at one U.S. center.

Disclosures: Dr. Diomampo had no disclosures.

VIDEO: Minimal disease activity criteria sought for axial spondyloarthritis

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VIDEO: Minimal disease activity criteria sought for axial spondyloarthritis

DENVER – U.S. rheumatologists plan to develop new criteria to define minimal disease activity in patients with axial spondyloarthritis to better gauge in routine clinical practice how well these patients respond to treatment.

A score on the Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 1.3 is the most commonly used measure today of minimal disease activity, but the ASDAS isn’t suitable for point-of-care assessment in routine practice because of the need for a C-reactive protein level or erythrocyte sedimentation rate.

Mitchel L. Zoler/Frontline Medical News
Dr. Lianne S. Gensler and Dr. Atul Deodhar

“In the clinic, ASDAS is very difficult or next to impossible to do” because it needs CRP or ESR, which are “never available at the point of care,” Atul A. Deodhar, MD, said in an interview at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN). Another limitation of ASDAS is that it focuses exclusively on musculoskeletal measures and does not take into account extra-articular manifestations of axial spondyloarthritis such as those in the eye, gastrointestinal tract, or skin.

“We would like a clinical measurement that might tell us that a patient is appropriately treated and at minimal disease activity,” said Dr. Deodhar, professor of medicine and medical director of the rheumatology clinics at Oregon Health & Science University in Portland.

As outgoing chair of SPARTAN, Dr. Deodhar introduced a proposal that SPARTAN develop new minimal disease activity criteria for patients with axial spondyloarthritis, presenting the rationale for this project at the meeting along with the incoming chair Lianne S. Gensler, MD.

“We want a way to measure disease activity at a stage that is not full remission but with enough of a reduction in disease activity to make a difference,” said Dr. Gensler, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco. Another frequently used gauge of minimal disease activity in axial spondyloarthritis, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), is flawed by being totally based on subjective measurements without input from the attending rheumatologist, Dr. Gensler said.

The SPARTAN leadership will try to partner in this effort with the OMERACT (Outcome Measures in Rheumatology) program, the Assessment of Spondyloarthritis International Society (ASAS), or both, but if necessary SPARTAN will develop new minimal disease activity criteria on its own, Dr. Deodhar said.

Dr. Deodhar has received research support from 10 drug companies. Dr. Gensler has been a consultant to or has received research support from AbbVie, Amgen, Janssen, Novartis, and UCB.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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DENVER – U.S. rheumatologists plan to develop new criteria to define minimal disease activity in patients with axial spondyloarthritis to better gauge in routine clinical practice how well these patients respond to treatment.

A score on the Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 1.3 is the most commonly used measure today of minimal disease activity, but the ASDAS isn’t suitable for point-of-care assessment in routine practice because of the need for a C-reactive protein level or erythrocyte sedimentation rate.

Mitchel L. Zoler/Frontline Medical News
Dr. Lianne S. Gensler and Dr. Atul Deodhar

“In the clinic, ASDAS is very difficult or next to impossible to do” because it needs CRP or ESR, which are “never available at the point of care,” Atul A. Deodhar, MD, said in an interview at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN). Another limitation of ASDAS is that it focuses exclusively on musculoskeletal measures and does not take into account extra-articular manifestations of axial spondyloarthritis such as those in the eye, gastrointestinal tract, or skin.

“We would like a clinical measurement that might tell us that a patient is appropriately treated and at minimal disease activity,” said Dr. Deodhar, professor of medicine and medical director of the rheumatology clinics at Oregon Health & Science University in Portland.

As outgoing chair of SPARTAN, Dr. Deodhar introduced a proposal that SPARTAN develop new minimal disease activity criteria for patients with axial spondyloarthritis, presenting the rationale for this project at the meeting along with the incoming chair Lianne S. Gensler, MD.

“We want a way to measure disease activity at a stage that is not full remission but with enough of a reduction in disease activity to make a difference,” said Dr. Gensler, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco. Another frequently used gauge of minimal disease activity in axial spondyloarthritis, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), is flawed by being totally based on subjective measurements without input from the attending rheumatologist, Dr. Gensler said.

The SPARTAN leadership will try to partner in this effort with the OMERACT (Outcome Measures in Rheumatology) program, the Assessment of Spondyloarthritis International Society (ASAS), or both, but if necessary SPARTAN will develop new minimal disease activity criteria on its own, Dr. Deodhar said.

Dr. Deodhar has received research support from 10 drug companies. Dr. Gensler has been a consultant to or has received research support from AbbVie, Amgen, Janssen, Novartis, and UCB.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

DENVER – U.S. rheumatologists plan to develop new criteria to define minimal disease activity in patients with axial spondyloarthritis to better gauge in routine clinical practice how well these patients respond to treatment.

A score on the Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 1.3 is the most commonly used measure today of minimal disease activity, but the ASDAS isn’t suitable for point-of-care assessment in routine practice because of the need for a C-reactive protein level or erythrocyte sedimentation rate.

Mitchel L. Zoler/Frontline Medical News
Dr. Lianne S. Gensler and Dr. Atul Deodhar

“In the clinic, ASDAS is very difficult or next to impossible to do” because it needs CRP or ESR, which are “never available at the point of care,” Atul A. Deodhar, MD, said in an interview at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN). Another limitation of ASDAS is that it focuses exclusively on musculoskeletal measures and does not take into account extra-articular manifestations of axial spondyloarthritis such as those in the eye, gastrointestinal tract, or skin.

“We would like a clinical measurement that might tell us that a patient is appropriately treated and at minimal disease activity,” said Dr. Deodhar, professor of medicine and medical director of the rheumatology clinics at Oregon Health & Science University in Portland.

As outgoing chair of SPARTAN, Dr. Deodhar introduced a proposal that SPARTAN develop new minimal disease activity criteria for patients with axial spondyloarthritis, presenting the rationale for this project at the meeting along with the incoming chair Lianne S. Gensler, MD.

“We want a way to measure disease activity at a stage that is not full remission but with enough of a reduction in disease activity to make a difference,” said Dr. Gensler, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco. Another frequently used gauge of minimal disease activity in axial spondyloarthritis, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), is flawed by being totally based on subjective measurements without input from the attending rheumatologist, Dr. Gensler said.

The SPARTAN leadership will try to partner in this effort with the OMERACT (Outcome Measures in Rheumatology) program, the Assessment of Spondyloarthritis International Society (ASAS), or both, but if necessary SPARTAN will develop new minimal disease activity criteria on its own, Dr. Deodhar said.

Dr. Deodhar has received research support from 10 drug companies. Dr. Gensler has been a consultant to or has received research support from AbbVie, Amgen, Janssen, Novartis, and UCB.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

On Twitter @mitchelzoler

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TNF inhibitors slow hip deterioration in ankylosing spondylitis

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TNF inhibitors slow hip deterioration in ankylosing spondylitis

DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Delamo Bekele

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News
Dr. Daphne Scaramangas-Plumley

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

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On Twitter @mitchelzoler

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DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Delamo Bekele

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News
Dr. Daphne Scaramangas-Plumley

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

[email protected]

On Twitter @mitchelzoler

DENVER – Treatment with a tumor necrosis factor inhibitor strongly linked with protection against progressive hip deterioration in observational data from 576 patients with ankylosing spondylitis enrolled in a prospective U.S. cohort.

But tumor necrosis factor (TNF) inhibitor treatment had less than full success for treating spondyloarthritis (SpA) disease activity in results from a separate registry study of 596 U.S. veterans diagnosed with SpA. About two-thirds were on a TNF inhibitor, and among these recipients, about 40% had suboptimal disease control, Delamo Bekele, MBBS, said at the annual meeting of the Spondyloarthritis (SpA) Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Delamo Bekele

This substantial rate of SpA patients with high disease activity despite TNF inhibitor treatment “suggests a need for more aggressive treatment,” with either a higher TNF inhibitor dosage or by treatment with a different biological drug, said Dr. Bekele, a rheumatologist at Howard University Hospital in Washington.

The analysis that assessed the impact of TNF inhibitor treatment on hip status used data from 576 AS patients enrolled in the Prospective Study of Outcomes in AS (PSOAS) at any of five U.S. centers. PSOAS included patients diagnosed with AS for at least 20 years, and the new study focused on patients who had undergone hip imaging at least twice while in the study and who entered with a Bath AS Radiologic Index (BASRI) hip score of less than 4. The analysis considered patients to have experienced progressive hip deterioration if they had a follow-up BASRI score that was at least two points higher than their baseline score. During a median 3 years of follow-up, 25 patients had this level of hip-disease progression.

Mitchel L. Zoler/Frontline Medical News
Dr. Daphne Scaramangas-Plumley

A multivariate analysis showed that the rate of hip disease progression was cut by 98% among patients on TNF inhibitor treatment, compared with those not on a TNF inhibitor, a highly significant difference between the two subgroups, reported Daphne Scaramangas-Plumley, MD, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. The only other variable identified that also correlated with the risk of hip progression was a patient’s hip score at baseline: For every additional point of the BASRI hip score the rate of later worsening rose by 60%.

The second study involved 596 U.S. veterans diagnosed with a type of SpA and enrolled in the Program to Understand the Longterm Outcomes in Spondyloarthritis (PULSAR) registry study at any of seven U.S. Department of Veterans Affairs centers. The analysis showed that about 64% of these SpA patients were receiving a TNF inhibitor. Among these patients on a TNF inhibitor, about 40% continued to have a Bath AS Disease Activity Index (BASDAI) score of 4 or higher, a level high enough to flag an inadequate response to current treatment.

Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

[email protected]

On Twitter @mitchelzoler

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AT THE 2016 SPARTAN ANNUAL MEETING

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Key clinical point: Ankylosing spondylitis patients on tumor necrosis factor inhibitor treatment had substantially better maintenance of hip function. In a second study, 40% of spondyloarthritis patients on a TNF inhibitor failed to receive adequate treatment efficacy.

Major finding: Tumor necrosis factor inhibitor treatment cut the rate of hip deterioration by 98%, compared with treatment without a biological drug.

Data source: PSOAS, a prospective observational study of 576 U.S. spondyloarthritis patients, and 596 U.S. veterans with SpA enrolled in the PULSAR registry study.

Disclosures: Dr. Scaramangas-Plumley and Dr. Bekele had no disclosures.

Routine cardiac screening in spondyloarthritis shown unneeded

Data confirm a no-screen approach
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DENVER – The largest controlled assessment of structural cardiac disease in patients with axial spondyloarthritis (SpA) failed to show any excess above a matched healthy sample, a finding that boosts recent guidelines that recommended against routine cardiac assessments in these patients.

“These findings provide the first evidence to support current recommendations against routine echocardiographic screening in asymptomatic patients with axial spondyloarthritis,” Risheen Reejhsinghani, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Risheen Reejhsinghani

“If a patient has symptoms of cardiac disease – uncontrolled hypertension, dyspnea, or chest pain – then you would do the appropriate testing as you would for anyone,” said Dr. Reejhsinghani, a cardiologist at the University of California, San Francisco.

Past reports from small and often uncontrolled groups of patients with ankylosing spondylitis (AS) had suggested a possible link between the disease and structural heart disease. The 2015 treatment recommendations for AS and axial SpA from the American College of Rheumatology and other organizations included a “strong” recommendation against screening for cardiac conduction defects or for valvular heart disease (Arthritis Rheum. 2016 Feb;68[2]:282-98).

The prospective study by Dr. Reejhsinghani and her associates enrolled 154 patients diagnosed with axial SpA and 51 age-matched controls recruited from Health eHeart participants, a community-based heart disease study run from San Francisco. Additional matching by hypertension status refined the population to 133 patients with axial SpA matched with 51 healthy controls. The researchers also did another prespecified analysis that compared the 51 controls with 94 age- and hypertension-matched patients who fulfilled the 1984 modified New York criteria for a specific diagnosis of AS. Overall, nearly two-thirds of the people in the study were men, they averaged about 43 years old, and the average duration from AS diagnosis was 18 years.

The researchers performed systematic cardiac examination by transthoracic echo in all 205 participants that examined them for aortic root size, aortic regurgitation, diastolic dysfunction, and size of the aortic annulus, sinotubular junction, and ascending aorta. These examinations identified an unusually large aortic root diameter in about 5% of the cases and 2% of the controls. Aortic insufficiency (regurgitation) occurred in about 40% of the cases and 50% of the controls. An analysis of the cases and controls that was matched for age and hypertension showed a diastolic dysfunction prevalence of 17% in the cases and 27% in the controls. None of the between-group differences were statistically significant. The results were similar for the entire age-matched group studied, the age- and hypertension-matched subgroup, and the AS subgroup.

Future studies need to examine the possible impact that various treatments, including biologics, have on the prevalence of cardiac disorders, Dr. Reejhsinghani said.

[email protected]

On Twitter @mitchelzoler

References

Body

Some patients with ankylosing spondylitis develop aortic insufficiency and need aortic valve replacements. Historically, clinicians worried about this risk and this led to a debate when an American College of Rheumatology panel recently developed ankylosing spondylitis treatment recommendations. This committee, on which I participated, decided to strongly recommend against routine screening with ECG or echocardiography. When we made that decision, we did not have these new data; we based our recommendation largely on our concerns about the cost efficacy of routine screening of asymptomatic patients.

Dr. David T.Y. Yu

The new findings reported by Dr. Reejhsinghani show for certain that we do not need routine structural screening on these patients. It’s certainly appropriate to assess a patient with ECG and echo if they have persistent hypertension, dyspnea, or other cardiac symptoms. I would also do further testing in an ankylosing spondylitis patient with a heart murmur, and it is also appropriate to keep in mind a possible increased risk in spondyloarthritis patients for ischemic cardiovascular diseases.

The data reported by Dr. Reejhsinghani are convincing, especially because of the matching she did to control for age and presence of hypertension.

David T.Y. Yu, MD, is a rheumatologist at the University of California, Los Angeles. He made these comments in an interview. He had no disclosures.

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Body

Some patients with ankylosing spondylitis develop aortic insufficiency and need aortic valve replacements. Historically, clinicians worried about this risk and this led to a debate when an American College of Rheumatology panel recently developed ankylosing spondylitis treatment recommendations. This committee, on which I participated, decided to strongly recommend against routine screening with ECG or echocardiography. When we made that decision, we did not have these new data; we based our recommendation largely on our concerns about the cost efficacy of routine screening of asymptomatic patients.

Dr. David T.Y. Yu

The new findings reported by Dr. Reejhsinghani show for certain that we do not need routine structural screening on these patients. It’s certainly appropriate to assess a patient with ECG and echo if they have persistent hypertension, dyspnea, or other cardiac symptoms. I would also do further testing in an ankylosing spondylitis patient with a heart murmur, and it is also appropriate to keep in mind a possible increased risk in spondyloarthritis patients for ischemic cardiovascular diseases.

The data reported by Dr. Reejhsinghani are convincing, especially because of the matching she did to control for age and presence of hypertension.

David T.Y. Yu, MD, is a rheumatologist at the University of California, Los Angeles. He made these comments in an interview. He had no disclosures.

Body

Some patients with ankylosing spondylitis develop aortic insufficiency and need aortic valve replacements. Historically, clinicians worried about this risk and this led to a debate when an American College of Rheumatology panel recently developed ankylosing spondylitis treatment recommendations. This committee, on which I participated, decided to strongly recommend against routine screening with ECG or echocardiography. When we made that decision, we did not have these new data; we based our recommendation largely on our concerns about the cost efficacy of routine screening of asymptomatic patients.

Dr. David T.Y. Yu

The new findings reported by Dr. Reejhsinghani show for certain that we do not need routine structural screening on these patients. It’s certainly appropriate to assess a patient with ECG and echo if they have persistent hypertension, dyspnea, or other cardiac symptoms. I would also do further testing in an ankylosing spondylitis patient with a heart murmur, and it is also appropriate to keep in mind a possible increased risk in spondyloarthritis patients for ischemic cardiovascular diseases.

The data reported by Dr. Reejhsinghani are convincing, especially because of the matching she did to control for age and presence of hypertension.

David T.Y. Yu, MD, is a rheumatologist at the University of California, Los Angeles. He made these comments in an interview. He had no disclosures.

Title
Data confirm a no-screen approach
Data confirm a no-screen approach

DENVER – The largest controlled assessment of structural cardiac disease in patients with axial spondyloarthritis (SpA) failed to show any excess above a matched healthy sample, a finding that boosts recent guidelines that recommended against routine cardiac assessments in these patients.

“These findings provide the first evidence to support current recommendations against routine echocardiographic screening in asymptomatic patients with axial spondyloarthritis,” Risheen Reejhsinghani, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Risheen Reejhsinghani

“If a patient has symptoms of cardiac disease – uncontrolled hypertension, dyspnea, or chest pain – then you would do the appropriate testing as you would for anyone,” said Dr. Reejhsinghani, a cardiologist at the University of California, San Francisco.

Past reports from small and often uncontrolled groups of patients with ankylosing spondylitis (AS) had suggested a possible link between the disease and structural heart disease. The 2015 treatment recommendations for AS and axial SpA from the American College of Rheumatology and other organizations included a “strong” recommendation against screening for cardiac conduction defects or for valvular heart disease (Arthritis Rheum. 2016 Feb;68[2]:282-98).

The prospective study by Dr. Reejhsinghani and her associates enrolled 154 patients diagnosed with axial SpA and 51 age-matched controls recruited from Health eHeart participants, a community-based heart disease study run from San Francisco. Additional matching by hypertension status refined the population to 133 patients with axial SpA matched with 51 healthy controls. The researchers also did another prespecified analysis that compared the 51 controls with 94 age- and hypertension-matched patients who fulfilled the 1984 modified New York criteria for a specific diagnosis of AS. Overall, nearly two-thirds of the people in the study were men, they averaged about 43 years old, and the average duration from AS diagnosis was 18 years.

The researchers performed systematic cardiac examination by transthoracic echo in all 205 participants that examined them for aortic root size, aortic regurgitation, diastolic dysfunction, and size of the aortic annulus, sinotubular junction, and ascending aorta. These examinations identified an unusually large aortic root diameter in about 5% of the cases and 2% of the controls. Aortic insufficiency (regurgitation) occurred in about 40% of the cases and 50% of the controls. An analysis of the cases and controls that was matched for age and hypertension showed a diastolic dysfunction prevalence of 17% in the cases and 27% in the controls. None of the between-group differences were statistically significant. The results were similar for the entire age-matched group studied, the age- and hypertension-matched subgroup, and the AS subgroup.

Future studies need to examine the possible impact that various treatments, including biologics, have on the prevalence of cardiac disorders, Dr. Reejhsinghani said.

[email protected]

On Twitter @mitchelzoler

DENVER – The largest controlled assessment of structural cardiac disease in patients with axial spondyloarthritis (SpA) failed to show any excess above a matched healthy sample, a finding that boosts recent guidelines that recommended against routine cardiac assessments in these patients.

“These findings provide the first evidence to support current recommendations against routine echocardiographic screening in asymptomatic patients with axial spondyloarthritis,” Risheen Reejhsinghani, MD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News
Dr. Risheen Reejhsinghani

“If a patient has symptoms of cardiac disease – uncontrolled hypertension, dyspnea, or chest pain – then you would do the appropriate testing as you would for anyone,” said Dr. Reejhsinghani, a cardiologist at the University of California, San Francisco.

Past reports from small and often uncontrolled groups of patients with ankylosing spondylitis (AS) had suggested a possible link between the disease and structural heart disease. The 2015 treatment recommendations for AS and axial SpA from the American College of Rheumatology and other organizations included a “strong” recommendation against screening for cardiac conduction defects or for valvular heart disease (Arthritis Rheum. 2016 Feb;68[2]:282-98).

The prospective study by Dr. Reejhsinghani and her associates enrolled 154 patients diagnosed with axial SpA and 51 age-matched controls recruited from Health eHeart participants, a community-based heart disease study run from San Francisco. Additional matching by hypertension status refined the population to 133 patients with axial SpA matched with 51 healthy controls. The researchers also did another prespecified analysis that compared the 51 controls with 94 age- and hypertension-matched patients who fulfilled the 1984 modified New York criteria for a specific diagnosis of AS. Overall, nearly two-thirds of the people in the study were men, they averaged about 43 years old, and the average duration from AS diagnosis was 18 years.

The researchers performed systematic cardiac examination by transthoracic echo in all 205 participants that examined them for aortic root size, aortic regurgitation, diastolic dysfunction, and size of the aortic annulus, sinotubular junction, and ascending aorta. These examinations identified an unusually large aortic root diameter in about 5% of the cases and 2% of the controls. Aortic insufficiency (regurgitation) occurred in about 40% of the cases and 50% of the controls. An analysis of the cases and controls that was matched for age and hypertension showed a diastolic dysfunction prevalence of 17% in the cases and 27% in the controls. None of the between-group differences were statistically significant. The results were similar for the entire age-matched group studied, the age- and hypertension-matched subgroup, and the AS subgroup.

Future studies need to examine the possible impact that various treatments, including biologics, have on the prevalence of cardiac disorders, Dr. Reejhsinghani said.

[email protected]

On Twitter @mitchelzoler

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Routine cardiac screening in spondyloarthritis shown unneeded
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AT THE 2016 SPARTAN ANNUAL MEETING

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Key clinical point: Patients with axial spondyloarthritis or ankylosing spondylitis had no excess prevalence of structural cardiac abnormalities in the largest controlled study yet reported.

Major finding: Aortic insufficiency occurred in about 40% of the axial spondyloarthritis cases and 50% of the matched controls.

Data source: A prospective, matched case and control study with 205 total subjects from a single U.S. center.

Disclosures: Dr. Reejhsinghani had no disclosures.