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Axial SpA features don’t guarantee its diagnosis in chronic back pain
The manifestation of multiple features of spondyloarthritis (SpA) in patients with chronic back pain is not sufficient for a diagnosis of axial spondyloarthritis, according to a report from Zineb Ez-Zaitouni and associates.
In a group of 250 people with chronic back pain who were not diagnosed with axial SpA, the most common alternative diagnosis was nonspecific back pain, followed by mechanical back pain, degenerative disc disease, and myalgia/fibromyalgia. Sacroiliitis on either radiographs or MRI and HLA-B27 was uncommon, and HLA-B27 positivity was also infrequent.
A total of 18 patients within the study group had at least four features of SpA but did not have axial SpA. Within this group, the most common SpA features were inflammatory back pain, a positive family history of SpA, a good response to nonsteroidal anti-inflammatory drugs, elevated C-reactive protein or erythrocyte sedimentation rate, and enthesitis. No patients had positive imaging, and only four were positive for HLA-B27.
“These findings show that rheumatologists in clinical practice rightly dispute a diagnosis of axSpA even when there is a high number of SpA features, especially when imaging is normal and patients are negative for HLA-B27,” the investigators concluded.
Find the full report in Annals of the Rheumatic Diseases (doi: 10.1136/annrheumdis-2017-212175)
The manifestation of multiple features of spondyloarthritis (SpA) in patients with chronic back pain is not sufficient for a diagnosis of axial spondyloarthritis, according to a report from Zineb Ez-Zaitouni and associates.
In a group of 250 people with chronic back pain who were not diagnosed with axial SpA, the most common alternative diagnosis was nonspecific back pain, followed by mechanical back pain, degenerative disc disease, and myalgia/fibromyalgia. Sacroiliitis on either radiographs or MRI and HLA-B27 was uncommon, and HLA-B27 positivity was also infrequent.
A total of 18 patients within the study group had at least four features of SpA but did not have axial SpA. Within this group, the most common SpA features were inflammatory back pain, a positive family history of SpA, a good response to nonsteroidal anti-inflammatory drugs, elevated C-reactive protein or erythrocyte sedimentation rate, and enthesitis. No patients had positive imaging, and only four were positive for HLA-B27.
“These findings show that rheumatologists in clinical practice rightly dispute a diagnosis of axSpA even when there is a high number of SpA features, especially when imaging is normal and patients are negative for HLA-B27,” the investigators concluded.
Find the full report in Annals of the Rheumatic Diseases (doi: 10.1136/annrheumdis-2017-212175)
The manifestation of multiple features of spondyloarthritis (SpA) in patients with chronic back pain is not sufficient for a diagnosis of axial spondyloarthritis, according to a report from Zineb Ez-Zaitouni and associates.
In a group of 250 people with chronic back pain who were not diagnosed with axial SpA, the most common alternative diagnosis was nonspecific back pain, followed by mechanical back pain, degenerative disc disease, and myalgia/fibromyalgia. Sacroiliitis on either radiographs or MRI and HLA-B27 was uncommon, and HLA-B27 positivity was also infrequent.
A total of 18 patients within the study group had at least four features of SpA but did not have axial SpA. Within this group, the most common SpA features were inflammatory back pain, a positive family history of SpA, a good response to nonsteroidal anti-inflammatory drugs, elevated C-reactive protein or erythrocyte sedimentation rate, and enthesitis. No patients had positive imaging, and only four were positive for HLA-B27.
“These findings show that rheumatologists in clinical practice rightly dispute a diagnosis of axSpA even when there is a high number of SpA features, especially when imaging is normal and patients are negative for HLA-B27,” the investigators concluded.
Find the full report in Annals of the Rheumatic Diseases (doi: 10.1136/annrheumdis-2017-212175)
FROM ANNALS OF THE RHEUMATIC DISEASES
Radiographic progression in axial spondyloarthritis moves slowly in first 5 years
Sacroiliac joint radiographic progression during the first 5 years of the onset of axial spondyloarthritis occurs to an extent related to the degree of inflammation seen on MRI at baseline, according to new findings from 416 French patients in the DESIR cohort.
Maxime Dougados, MD, of Paris Descartes University, and his colleagues found that 15% of patients at baseline met modified New York (mNY) criteria – and therefore had radiographic axial spondyloarthritis (r-axSpA) – and this increased to 20% at 5 years. During the 5-year follow-up, the net percentage of patients who progressed was 5% (those who went from nonradiographic axial spondyloarthritis [nr-axSpA] to r-axSpA minus those who regressed from r-axSpA to nr-axSpA). Overall, 13% changed at least one grade on mNY criteria, and if an mNY criteria grade change from zero to one was not considered, only 10% experienced a change in at least one grade. These patients overall had a mean age of 34 years and had inflammatory back pain that had lasted at least 3 months but less than 3 years.
“The association between baseline MRI inflammation and 5-year SIJ damage was consistently found, regardless of the analytical method and the definition of SIJ progression,” the investigators wrote.
The estimated risk for progression by at least one mNY criteria grade varied from as high as 18% in HLA-B27–positive individuals with baseline SIJ inflammation on MRI and elevated C-reactive protein to just 1% in those who were negative for those three variables.
Read the full report online (Ann Rheum Dis. 2017 Jul 6. doi: 10.1136/annrheumdis-2017-211596).
Sacroiliac joint radiographic progression during the first 5 years of the onset of axial spondyloarthritis occurs to an extent related to the degree of inflammation seen on MRI at baseline, according to new findings from 416 French patients in the DESIR cohort.
Maxime Dougados, MD, of Paris Descartes University, and his colleagues found that 15% of patients at baseline met modified New York (mNY) criteria – and therefore had radiographic axial spondyloarthritis (r-axSpA) – and this increased to 20% at 5 years. During the 5-year follow-up, the net percentage of patients who progressed was 5% (those who went from nonradiographic axial spondyloarthritis [nr-axSpA] to r-axSpA minus those who regressed from r-axSpA to nr-axSpA). Overall, 13% changed at least one grade on mNY criteria, and if an mNY criteria grade change from zero to one was not considered, only 10% experienced a change in at least one grade. These patients overall had a mean age of 34 years and had inflammatory back pain that had lasted at least 3 months but less than 3 years.
“The association between baseline MRI inflammation and 5-year SIJ damage was consistently found, regardless of the analytical method and the definition of SIJ progression,” the investigators wrote.
The estimated risk for progression by at least one mNY criteria grade varied from as high as 18% in HLA-B27–positive individuals with baseline SIJ inflammation on MRI and elevated C-reactive protein to just 1% in those who were negative for those three variables.
Read the full report online (Ann Rheum Dis. 2017 Jul 6. doi: 10.1136/annrheumdis-2017-211596).
Sacroiliac joint radiographic progression during the first 5 years of the onset of axial spondyloarthritis occurs to an extent related to the degree of inflammation seen on MRI at baseline, according to new findings from 416 French patients in the DESIR cohort.
Maxime Dougados, MD, of Paris Descartes University, and his colleagues found that 15% of patients at baseline met modified New York (mNY) criteria – and therefore had radiographic axial spondyloarthritis (r-axSpA) – and this increased to 20% at 5 years. During the 5-year follow-up, the net percentage of patients who progressed was 5% (those who went from nonradiographic axial spondyloarthritis [nr-axSpA] to r-axSpA minus those who regressed from r-axSpA to nr-axSpA). Overall, 13% changed at least one grade on mNY criteria, and if an mNY criteria grade change from zero to one was not considered, only 10% experienced a change in at least one grade. These patients overall had a mean age of 34 years and had inflammatory back pain that had lasted at least 3 months but less than 3 years.
“The association between baseline MRI inflammation and 5-year SIJ damage was consistently found, regardless of the analytical method and the definition of SIJ progression,” the investigators wrote.
The estimated risk for progression by at least one mNY criteria grade varied from as high as 18% in HLA-B27–positive individuals with baseline SIJ inflammation on MRI and elevated C-reactive protein to just 1% in those who were negative for those three variables.
Read the full report online (Ann Rheum Dis. 2017 Jul 6. doi: 10.1136/annrheumdis-2017-211596).
FROM ANNALS OF THE RHEUMATIC DISEASES
First interchangeability study for an adalimumab biosimilar has begun
The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.
This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.
In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.
A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.
The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.
This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.
In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.
A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.
The VOLTAIRE-X study of a biosimilar candidate for adalimumab (Humira) for chronic plaque psoriasis has enrolled its first patient, announced Boehringer Ingelheim, the biosimilar’s developer, on July 27.
This is the first study in the United States to investigate whether a biosimilar candidate should be granted an interchangeability designation with adalimumab. The candidate, BI 695501, is up against adalimumab’s 40-mg injection.
In VOLTAIRE-X, some patients will alternate between adalimumab and BI 695501, and others will take adalimumab continuously. The study will compare the pharmacokinetics, clinical outcomes, safety, immunogenicity, and efficacy between the two groups of patients. The estimated enrollment of adult patients with moderate to severe chronic plaque psoriasis is 240, and the study is expected to conclude in July 2019.
A phase 3 study of BI 695501’s performance for rheumatoid arthritis patients, completed in 2016, demonstrated similar efficacy, safety, and immunogenicity.
CT scoring system may improve sacroiliitis treatment in IBD
A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.
Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.
By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.
The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.
A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.
Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.
By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.
The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.
A standardized scoring system to identify sacroiliitis could enable patients with inflammatory bowel disease to get earlier rheumatology referrals and improve treatment, according to an analysis of IBD patients with pre-existing abdominal CT scans.
Of the 316 patients recruited from an IBD clinic in Toronto, the validated CT scan scoring system identified 49 with sacroiliitis, of whom only 5 had been referred to an outpatient rheumatology clinic in the city. Rates of sacroiliitis were similar between the 233 patients with Crohn’s disease (15%) and the 83 with ulcerative colitis (16.9%). The scoring system indicated sacroiliitis in 6 (5.6%) of the 108 control subjects, who were recruited from a urology clinic and had no prior history of chronic back pain, reported Jonathan Chan, MD, of the University of Toronto and his associates (Arthritis Care Res. 2017 Jul 21. doi: 10.1002/acr.23323).“Previous studies using CT scan to detect sacroiliitis have relied upon an adaptation of the [modified New York] criteria or a radiologist’s gestalt. Such an adaptation may not be appropriate since changes suggestive of sacroiliitis can be found in the healthy population due to the increased sensitivity of CT scans,” the investigators said. They developed a CT-scan scoring system in which the sacroiliac joints are divided into left/right and iliac/sacral segments. The slice with the greatest number of erosions in each of the four segments contributes that value to the total erosion score, with a score of 3 or greater identifying the presence of sacroiliitis.
By demonstrating that sacroiliitis is three times more prevalent among IBD patients and can be reliably detected in CT scans performed in the clinical care of those patients, this study suggests that “more timely referral for rheumatology assessment” could avoid unnecessary treatment with biologics, Dr. Chan and his associates wrote.
The study was supported in part by a fellowship grant from the Assessment of Spondyloarthritis International Society and in part by Janssen. The investigators reported having no conflicts of interest for the study.
FROM ARTHRITIS CARE & RESEARCH
TNFi treatment halves ankylosing spondylitis progression
MADRID – At least 2 years of tumor necrosis factor–inhibitor treatment of patients with ankylosing spondylitis nearly halved the rate of spinal radiographic progression in a study involving 432 Swiss patients.
In addition, patients on a tumor necrosis factor inhibitor (TNFi) who achieved low disease activity, reflected in an Ankylosing Spondylitis (AS) Disease Activity Score of 1.3 or less, showed virtually no spinal radiographic progression during a 2-year follow-up, Adrian Ciurea, MD, reported at the European Congress of Rheumatology.
He cautioned, however, that the evidence only shows correlation and can’t prove a causal relationship between TNFi treatment and slowed spinal radiographic progression because of potential residual confounding.
Dr. Ciurea and his associates analyzed records for AS patients enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases cohort who underwent at least two spinal radiographs separated by a 2-year gap. They assessed the radiographs using the modified Stoke AS Spinal Score (mSASSS), and they defined progression as a gain of at least two units on the mSASSS during a 2-year period between radiographs.
The 432 AS patients in the study averaged 40 years old, two-thirds were men, and they had AS symptoms for an average of nearly 14 years. Their average AS Disease Activity Score (ASDAS) at entry was 2.8.
A multivariate analysis that controlled for several variables, including sex, smoking history, baseline mSASSS, and exercise, identified three parameters that had significant correlations with radiographic progression: Men had more than double the rate of progression, compared with women; higher baseline mSASSS was linked with a higher rate of progression; and a greater-than-2-year history of treatment with a TNFi was linked with a 48% reduced rate of progression, reported Dr. Ciurea, a rheumatologist at the Zürich University Hospital.
The duration of treatment also mattered. Patients who received at least 4 years of TNFi treatment had a statistically significant 68% reduced rate of radiographic spinal progression. In contrast, patients who received a TNFi for fewer than 4 years but more than 2 years had a 42% lower rate of progression that was of borderline statistical significance. TNFi treatment that started during the 2 years immediately preceding the radiograph failed to show a significant link with reduced progression.
Further analysis also showed a tight correlation between patients’ disease activity while on TNFi treatment and radiographic progression. Patients who maintained an average ASDAS of 2.1 or less during the 2 years prior to radiographic assessment showed an average mSASSS gain of 0.31 units over that 2-year period, compared with an average 1.45-unit mSASSS gain among patients whose average ASDAS remained above 2.1, a statistically significant difference between these two groups. Patients with even more inactive disease on TNFi treatment – those who maintained an average ASDAS of 1.3 or less – had an average 0.01-unit rise in their mSASSS after 2 years of treatment, compared with an average 0.52-unit mSASSS rise after 2 years in patients with an ASDAS of more than 1.3 but less than 2.1, he said.
The cohort study received partial support from Merck Sharpe & Dohme. Dr. Ciurea has been a consultant to or speaker for Abbvie, Celgene, Eli Lilly, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, and UCB.
[email protected]
On Twitter @mitchelzoler
MADRID – At least 2 years of tumor necrosis factor–inhibitor treatment of patients with ankylosing spondylitis nearly halved the rate of spinal radiographic progression in a study involving 432 Swiss patients.
In addition, patients on a tumor necrosis factor inhibitor (TNFi) who achieved low disease activity, reflected in an Ankylosing Spondylitis (AS) Disease Activity Score of 1.3 or less, showed virtually no spinal radiographic progression during a 2-year follow-up, Adrian Ciurea, MD, reported at the European Congress of Rheumatology.
He cautioned, however, that the evidence only shows correlation and can’t prove a causal relationship between TNFi treatment and slowed spinal radiographic progression because of potential residual confounding.
Dr. Ciurea and his associates analyzed records for AS patients enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases cohort who underwent at least two spinal radiographs separated by a 2-year gap. They assessed the radiographs using the modified Stoke AS Spinal Score (mSASSS), and they defined progression as a gain of at least two units on the mSASSS during a 2-year period between radiographs.
The 432 AS patients in the study averaged 40 years old, two-thirds were men, and they had AS symptoms for an average of nearly 14 years. Their average AS Disease Activity Score (ASDAS) at entry was 2.8.
A multivariate analysis that controlled for several variables, including sex, smoking history, baseline mSASSS, and exercise, identified three parameters that had significant correlations with radiographic progression: Men had more than double the rate of progression, compared with women; higher baseline mSASSS was linked with a higher rate of progression; and a greater-than-2-year history of treatment with a TNFi was linked with a 48% reduced rate of progression, reported Dr. Ciurea, a rheumatologist at the Zürich University Hospital.
The duration of treatment also mattered. Patients who received at least 4 years of TNFi treatment had a statistically significant 68% reduced rate of radiographic spinal progression. In contrast, patients who received a TNFi for fewer than 4 years but more than 2 years had a 42% lower rate of progression that was of borderline statistical significance. TNFi treatment that started during the 2 years immediately preceding the radiograph failed to show a significant link with reduced progression.
Further analysis also showed a tight correlation between patients’ disease activity while on TNFi treatment and radiographic progression. Patients who maintained an average ASDAS of 2.1 or less during the 2 years prior to radiographic assessment showed an average mSASSS gain of 0.31 units over that 2-year period, compared with an average 1.45-unit mSASSS gain among patients whose average ASDAS remained above 2.1, a statistically significant difference between these two groups. Patients with even more inactive disease on TNFi treatment – those who maintained an average ASDAS of 1.3 or less – had an average 0.01-unit rise in their mSASSS after 2 years of treatment, compared with an average 0.52-unit mSASSS rise after 2 years in patients with an ASDAS of more than 1.3 but less than 2.1, he said.
The cohort study received partial support from Merck Sharpe & Dohme. Dr. Ciurea has been a consultant to or speaker for Abbvie, Celgene, Eli Lilly, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, and UCB.
[email protected]
On Twitter @mitchelzoler
MADRID – At least 2 years of tumor necrosis factor–inhibitor treatment of patients with ankylosing spondylitis nearly halved the rate of spinal radiographic progression in a study involving 432 Swiss patients.
In addition, patients on a tumor necrosis factor inhibitor (TNFi) who achieved low disease activity, reflected in an Ankylosing Spondylitis (AS) Disease Activity Score of 1.3 or less, showed virtually no spinal radiographic progression during a 2-year follow-up, Adrian Ciurea, MD, reported at the European Congress of Rheumatology.
He cautioned, however, that the evidence only shows correlation and can’t prove a causal relationship between TNFi treatment and slowed spinal radiographic progression because of potential residual confounding.
Dr. Ciurea and his associates analyzed records for AS patients enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases cohort who underwent at least two spinal radiographs separated by a 2-year gap. They assessed the radiographs using the modified Stoke AS Spinal Score (mSASSS), and they defined progression as a gain of at least two units on the mSASSS during a 2-year period between radiographs.
The 432 AS patients in the study averaged 40 years old, two-thirds were men, and they had AS symptoms for an average of nearly 14 years. Their average AS Disease Activity Score (ASDAS) at entry was 2.8.
A multivariate analysis that controlled for several variables, including sex, smoking history, baseline mSASSS, and exercise, identified three parameters that had significant correlations with radiographic progression: Men had more than double the rate of progression, compared with women; higher baseline mSASSS was linked with a higher rate of progression; and a greater-than-2-year history of treatment with a TNFi was linked with a 48% reduced rate of progression, reported Dr. Ciurea, a rheumatologist at the Zürich University Hospital.
The duration of treatment also mattered. Patients who received at least 4 years of TNFi treatment had a statistically significant 68% reduced rate of radiographic spinal progression. In contrast, patients who received a TNFi for fewer than 4 years but more than 2 years had a 42% lower rate of progression that was of borderline statistical significance. TNFi treatment that started during the 2 years immediately preceding the radiograph failed to show a significant link with reduced progression.
Further analysis also showed a tight correlation between patients’ disease activity while on TNFi treatment and radiographic progression. Patients who maintained an average ASDAS of 2.1 or less during the 2 years prior to radiographic assessment showed an average mSASSS gain of 0.31 units over that 2-year period, compared with an average 1.45-unit mSASSS gain among patients whose average ASDAS remained above 2.1, a statistically significant difference between these two groups. Patients with even more inactive disease on TNFi treatment – those who maintained an average ASDAS of 1.3 or less – had an average 0.01-unit rise in their mSASSS after 2 years of treatment, compared with an average 0.52-unit mSASSS rise after 2 years in patients with an ASDAS of more than 1.3 but less than 2.1, he said.
The cohort study received partial support from Merck Sharpe & Dohme. Dr. Ciurea has been a consultant to or speaker for Abbvie, Celgene, Eli Lilly, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, and UCB.
[email protected]
On Twitter @mitchelzoler
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Prolonged TNFi treatment was linked with a 48% lower rate of spinal radiographic progression, compared with shorter treatment.
Data source: Review of 432 patients in the Swiss Clinical Quality Management in Rheumatic Diseases cohort.
Disclosures: The cohort study received partial support from Merck Sharpe & Dohme. Dr. Ciurea has been a consultant to or speaker for Abbvie, Celgene, Eli Lilly, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, and UCB.
Obesity blunts TNFi response in axial spondyloarthritis
MADRID – Obese patients with axial spondyloarthritis were substantially less responsive to treatment with a tumor necrosis factor inhibitor than were healthy-weight patients in a multicenter Swiss study with 531 patients.
In a multivariate analysis that controlled for several demographic and clinical factors, including baseline disease severity, obese patients with axial spondyloarthritis (SpA) were 70% less likely to achieve a 40% or better improvement in their Assessment in SpondyloArthritis International Society improvement criteria (ASAS 40) when compared with patients with a healthy body mass index (BMI), Raphael Micheroli, MD, reported in a poster at the European Congress of Rheumatology.
The finding supplies a third reason why patients with newly diagnosed axial SpA should try to lose weight if they are obese (or overweight) – to potentially improve their responsiveness to a TNFi. The other two reasons are to reduce cardiovascular disease risk in patients who are already at risk for these complications because of their disease, and to also help improve their ability to perform physical activities, he explained in an interview.
Dr. Micheroli proposed three possible reasons why obese patients with axial SpA might be less responsive to a TNFi than healthy-weight patients: They receive an inadequate TNFi dosage, their increased adipose tissue produces excess proinflammatory cytokines that exacerbate their axial SpA, or it is possible that obese patients are more likely to be misdiagnosed with axial SpA and because they don’t really have this disease their symptoms cannot improve with TNFi treatment. They may instead have, for example, degenerative back pain, a condition that can be challenging to distinguish from axial SpA, he said.
A role for obesity in blunting the beneficial effects of TNFi treatment has been well described for psoriatic arthritis, for example, in an Italian study with 138 patients (Ann Rheum Dis. 2014 June;73[6]:1157-62), and in a Danish study with more than 1,200 patients (Rheumatology [Oxford]. 2016 Dec;55[12]:2191-9).
Dr. Micheroli’s study included 624 patients with axial SpA enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases axial spondyloarthritis cohort who met the ASAS classification criteria for axial SpA and started treatment with their first TNFi after they entered the cohort. Follow-up data after 1 year on treatment were available for 531 of these patients. The entry group included 332 patients (53%) with a healthy BMI, 204 (33%) with an overweight BMI (25-30 kg/m2), and 88 (14%) obese patients (BMI more than 30 kg/m2). The patients averaged about 40 years old and had been symptomatic for an average of about 13 years. About one-third of patients started on adalimumab (Humira) treatment, about one-quarter started etanercept (Enbrel), more than one-fifth began infliximab (Remicade), and some patients started treatment with either golimumab (Simponi) or certolizumab pegol (Cimzia).
After 1 year on TNFi treatment, ASAS 40 improvement occurred in 44% of 282 healthy-BMI patients, 34% of 178 overweight patients, and in 29% of 71 obese patients, Dr. Micheroli reported. In a baseline-adjusted multivariate model, this difference translated into an odds ratio of 0.30 for obese patients achieving an ASAS 40 response, compared with the healthy-BMI patients after 1 year, a statistically significant difference. Further analysis showed no statistically significant differences in TNFi discontinuation rates among the three BMI subgroups.
Dr. Micheroli had no disclosures.
[email protected]
On Twitter @mitchelzoler
MADRID – Obese patients with axial spondyloarthritis were substantially less responsive to treatment with a tumor necrosis factor inhibitor than were healthy-weight patients in a multicenter Swiss study with 531 patients.
In a multivariate analysis that controlled for several demographic and clinical factors, including baseline disease severity, obese patients with axial spondyloarthritis (SpA) were 70% less likely to achieve a 40% or better improvement in their Assessment in SpondyloArthritis International Society improvement criteria (ASAS 40) when compared with patients with a healthy body mass index (BMI), Raphael Micheroli, MD, reported in a poster at the European Congress of Rheumatology.
The finding supplies a third reason why patients with newly diagnosed axial SpA should try to lose weight if they are obese (or overweight) – to potentially improve their responsiveness to a TNFi. The other two reasons are to reduce cardiovascular disease risk in patients who are already at risk for these complications because of their disease, and to also help improve their ability to perform physical activities, he explained in an interview.
Dr. Micheroli proposed three possible reasons why obese patients with axial SpA might be less responsive to a TNFi than healthy-weight patients: They receive an inadequate TNFi dosage, their increased adipose tissue produces excess proinflammatory cytokines that exacerbate their axial SpA, or it is possible that obese patients are more likely to be misdiagnosed with axial SpA and because they don’t really have this disease their symptoms cannot improve with TNFi treatment. They may instead have, for example, degenerative back pain, a condition that can be challenging to distinguish from axial SpA, he said.
A role for obesity in blunting the beneficial effects of TNFi treatment has been well described for psoriatic arthritis, for example, in an Italian study with 138 patients (Ann Rheum Dis. 2014 June;73[6]:1157-62), and in a Danish study with more than 1,200 patients (Rheumatology [Oxford]. 2016 Dec;55[12]:2191-9).
Dr. Micheroli’s study included 624 patients with axial SpA enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases axial spondyloarthritis cohort who met the ASAS classification criteria for axial SpA and started treatment with their first TNFi after they entered the cohort. Follow-up data after 1 year on treatment were available for 531 of these patients. The entry group included 332 patients (53%) with a healthy BMI, 204 (33%) with an overweight BMI (25-30 kg/m2), and 88 (14%) obese patients (BMI more than 30 kg/m2). The patients averaged about 40 years old and had been symptomatic for an average of about 13 years. About one-third of patients started on adalimumab (Humira) treatment, about one-quarter started etanercept (Enbrel), more than one-fifth began infliximab (Remicade), and some patients started treatment with either golimumab (Simponi) or certolizumab pegol (Cimzia).
After 1 year on TNFi treatment, ASAS 40 improvement occurred in 44% of 282 healthy-BMI patients, 34% of 178 overweight patients, and in 29% of 71 obese patients, Dr. Micheroli reported. In a baseline-adjusted multivariate model, this difference translated into an odds ratio of 0.30 for obese patients achieving an ASAS 40 response, compared with the healthy-BMI patients after 1 year, a statistically significant difference. Further analysis showed no statistically significant differences in TNFi discontinuation rates among the three BMI subgroups.
Dr. Micheroli had no disclosures.
[email protected]
On Twitter @mitchelzoler
MADRID – Obese patients with axial spondyloarthritis were substantially less responsive to treatment with a tumor necrosis factor inhibitor than were healthy-weight patients in a multicenter Swiss study with 531 patients.
In a multivariate analysis that controlled for several demographic and clinical factors, including baseline disease severity, obese patients with axial spondyloarthritis (SpA) were 70% less likely to achieve a 40% or better improvement in their Assessment in SpondyloArthritis International Society improvement criteria (ASAS 40) when compared with patients with a healthy body mass index (BMI), Raphael Micheroli, MD, reported in a poster at the European Congress of Rheumatology.
The finding supplies a third reason why patients with newly diagnosed axial SpA should try to lose weight if they are obese (or overweight) – to potentially improve their responsiveness to a TNFi. The other two reasons are to reduce cardiovascular disease risk in patients who are already at risk for these complications because of their disease, and to also help improve their ability to perform physical activities, he explained in an interview.
Dr. Micheroli proposed three possible reasons why obese patients with axial SpA might be less responsive to a TNFi than healthy-weight patients: They receive an inadequate TNFi dosage, their increased adipose tissue produces excess proinflammatory cytokines that exacerbate their axial SpA, or it is possible that obese patients are more likely to be misdiagnosed with axial SpA and because they don’t really have this disease their symptoms cannot improve with TNFi treatment. They may instead have, for example, degenerative back pain, a condition that can be challenging to distinguish from axial SpA, he said.
A role for obesity in blunting the beneficial effects of TNFi treatment has been well described for psoriatic arthritis, for example, in an Italian study with 138 patients (Ann Rheum Dis. 2014 June;73[6]:1157-62), and in a Danish study with more than 1,200 patients (Rheumatology [Oxford]. 2016 Dec;55[12]:2191-9).
Dr. Micheroli’s study included 624 patients with axial SpA enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases axial spondyloarthritis cohort who met the ASAS classification criteria for axial SpA and started treatment with their first TNFi after they entered the cohort. Follow-up data after 1 year on treatment were available for 531 of these patients. The entry group included 332 patients (53%) with a healthy BMI, 204 (33%) with an overweight BMI (25-30 kg/m2), and 88 (14%) obese patients (BMI more than 30 kg/m2). The patients averaged about 40 years old and had been symptomatic for an average of about 13 years. About one-third of patients started on adalimumab (Humira) treatment, about one-quarter started etanercept (Enbrel), more than one-fifth began infliximab (Remicade), and some patients started treatment with either golimumab (Simponi) or certolizumab pegol (Cimzia).
After 1 year on TNFi treatment, ASAS 40 improvement occurred in 44% of 282 healthy-BMI patients, 34% of 178 overweight patients, and in 29% of 71 obese patients, Dr. Micheroli reported. In a baseline-adjusted multivariate model, this difference translated into an odds ratio of 0.30 for obese patients achieving an ASAS 40 response, compared with the healthy-BMI patients after 1 year, a statistically significant difference. Further analysis showed no statistically significant differences in TNFi discontinuation rates among the three BMI subgroups.
Dr. Micheroli had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Obese patients had a 70% lower response rate to a tumor necrosis factor inhibitor, compared with healthy-weight patients.
Data source: A cohort of 531 axial spondyloarthritis patients enrolled in the Swiss Clinical Quality Management in Rheumatic Diseases program.
Disclosures: Dr. Micheroli had no disclosures.
VIDEO: Rheumatology biosimilars gain U.S. momentum
MADRID – With biosimilar infliximab on the U.S. market since November 2016 and producing an immediate, albeit modest, price drop for this tumor necrosis factor inhibitor (TNFi) and a second biosimilar infliximab now approved by the Food and Drug Administration and awaiting market entry, biosimilars are in a new phase of integration into U.S. practice.
“Physicians are willing to prescribe Inflectra,” the first biosimilar infliximab and the first TNFi to be sold in the United States last November, Jonathan Kay, MD, said in a video interview during the European Congress of Rheumatology. “Rheumatologists who were initially skeptical are now on the bandwagon and willing to prescribe biosimilars,” said Dr. Kay, a rheumatologist who has often consulted on biosimilar issues and has recently spoken to rheumatologists at various state society meetings to explain the U.S. biosimilar regulatory concepts and spread the message of the societal value of these agents.
“This is not a quick and casual drug evaluation” that produces “knockoff drugs,” but a “careful and extensive” FDA review that results in drugs that are equivalent in efficacy, safety, and immunogenicity to the reference drug and only compete on price, he explained.
When Pfizer began marketing Inflectra last Fall, it set the drug’s list price 15% lower than the list price at the time for Remicade, the reference-product infliximab. However, complex pricing and rebate strategies actually led to Remicade selling for a lower price than Inflectra, at least for some U.S. hospitals, including the University of Massachusetts in Worcester, where Dr. Kay is a professor of medicine.
“The effect of biosimilars is to reduce the cost to patients of an effective treatment. Whether that cost is for the reference drug or for the biosimilar drug doesn’t matter [from society’s perspective] as long as patients are able to receive an effective therapy at a [more] affordable cost, making the effective therapy available to more patients,” he said.
While Inflectra’s price impact my have been modest so far, the biosimilar effect on infliximab’s cost may soon intensify now that a second biosimilar of this TNFi, Renflexis – made by Samsung Bioepis and with U.S. marketing by Merck, received FDA approval on April 21, 2017. Until recently, U.S. pharmaceutical regulations had been understood to require a 180-day hiatus between FDA marketing approval for a biosimilar and the start of U.S. sales. But, on June 12, 2017, the U.S. Supreme Court, in a 9-0 decision, ruled that this 180-day wait was not required, making it possible for U.S. marketing of Renflexis to begin soon. (In mid-June, a statement on the Merck U.S. website for Renflexis says that the product is not currently available.)
Availability of a second biosimilar infliximab “is likely to drive the price down rapidly,” predicted Dr. Kay, citing what happened when multiple biosimilars for a reference drug came onto the European market.
Two other biosimilar TNFi have also received FDA marketing approvals but remain on hold as patent issues and litigation barriers play out. Erelzi – biosimilar etanercept – received FDA approval in August 2016, and Amjevita, biosimilar adalimumab, received FDA approval last September.
The efficacy and safety of Inflectra specifically, and by extension all biosimilars, received a recent boost with publication of findings from a randomized study with 482 patients that provided a real-world test of the core principle of biosimilar equivalence. After Inflectra came onto the Norwegian market, during July 2014 to August 2015, Norwegian researchers ran the NOR-SWTICH trial, which randomized patients who were on stable treatment with Remicade for a variety of indications (including 41% with a rheumatologic disease) to either stay on Remicade or to abruptly switch to treatment with Inflectra. During 1-year follow-up, the incidence of adverse effects and of episodes of disease worsening were virtually identical in the two treatment arms (Lancet. 2017 June 10;389[10086]:2304-16).
Dr. Kay has been a consultant to several companies that develop or market biosimilars, including Samsung Bioepis, Amgen, Pfizer, and Sandoz (Novartis), and to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Janssen, Roche, 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
MADRID – With biosimilar infliximab on the U.S. market since November 2016 and producing an immediate, albeit modest, price drop for this tumor necrosis factor inhibitor (TNFi) and a second biosimilar infliximab now approved by the Food and Drug Administration and awaiting market entry, biosimilars are in a new phase of integration into U.S. practice.
“Physicians are willing to prescribe Inflectra,” the first biosimilar infliximab and the first TNFi to be sold in the United States last November, Jonathan Kay, MD, said in a video interview during the European Congress of Rheumatology. “Rheumatologists who were initially skeptical are now on the bandwagon and willing to prescribe biosimilars,” said Dr. Kay, a rheumatologist who has often consulted on biosimilar issues and has recently spoken to rheumatologists at various state society meetings to explain the U.S. biosimilar regulatory concepts and spread the message of the societal value of these agents.
“This is not a quick and casual drug evaluation” that produces “knockoff drugs,” but a “careful and extensive” FDA review that results in drugs that are equivalent in efficacy, safety, and immunogenicity to the reference drug and only compete on price, he explained.
When Pfizer began marketing Inflectra last Fall, it set the drug’s list price 15% lower than the list price at the time for Remicade, the reference-product infliximab. However, complex pricing and rebate strategies actually led to Remicade selling for a lower price than Inflectra, at least for some U.S. hospitals, including the University of Massachusetts in Worcester, where Dr. Kay is a professor of medicine.
“The effect of biosimilars is to reduce the cost to patients of an effective treatment. Whether that cost is for the reference drug or for the biosimilar drug doesn’t matter [from society’s perspective] as long as patients are able to receive an effective therapy at a [more] affordable cost, making the effective therapy available to more patients,” he said.
While Inflectra’s price impact my have been modest so far, the biosimilar effect on infliximab’s cost may soon intensify now that a second biosimilar of this TNFi, Renflexis – made by Samsung Bioepis and with U.S. marketing by Merck, received FDA approval on April 21, 2017. Until recently, U.S. pharmaceutical regulations had been understood to require a 180-day hiatus between FDA marketing approval for a biosimilar and the start of U.S. sales. But, on June 12, 2017, the U.S. Supreme Court, in a 9-0 decision, ruled that this 180-day wait was not required, making it possible for U.S. marketing of Renflexis to begin soon. (In mid-June, a statement on the Merck U.S. website for Renflexis says that the product is not currently available.)
Availability of a second biosimilar infliximab “is likely to drive the price down rapidly,” predicted Dr. Kay, citing what happened when multiple biosimilars for a reference drug came onto the European market.
Two other biosimilar TNFi have also received FDA marketing approvals but remain on hold as patent issues and litigation barriers play out. Erelzi – biosimilar etanercept – received FDA approval in August 2016, and Amjevita, biosimilar adalimumab, received FDA approval last September.
The efficacy and safety of Inflectra specifically, and by extension all biosimilars, received a recent boost with publication of findings from a randomized study with 482 patients that provided a real-world test of the core principle of biosimilar equivalence. After Inflectra came onto the Norwegian market, during July 2014 to August 2015, Norwegian researchers ran the NOR-SWTICH trial, which randomized patients who were on stable treatment with Remicade for a variety of indications (including 41% with a rheumatologic disease) to either stay on Remicade or to abruptly switch to treatment with Inflectra. During 1-year follow-up, the incidence of adverse effects and of episodes of disease worsening were virtually identical in the two treatment arms (Lancet. 2017 June 10;389[10086]:2304-16).
Dr. Kay has been a consultant to several companies that develop or market biosimilars, including Samsung Bioepis, Amgen, Pfizer, and Sandoz (Novartis), and to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Janssen, Roche, 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
MADRID – With biosimilar infliximab on the U.S. market since November 2016 and producing an immediate, albeit modest, price drop for this tumor necrosis factor inhibitor (TNFi) and a second biosimilar infliximab now approved by the Food and Drug Administration and awaiting market entry, biosimilars are in a new phase of integration into U.S. practice.
“Physicians are willing to prescribe Inflectra,” the first biosimilar infliximab and the first TNFi to be sold in the United States last November, Jonathan Kay, MD, said in a video interview during the European Congress of Rheumatology. “Rheumatologists who were initially skeptical are now on the bandwagon and willing to prescribe biosimilars,” said Dr. Kay, a rheumatologist who has often consulted on biosimilar issues and has recently spoken to rheumatologists at various state society meetings to explain the U.S. biosimilar regulatory concepts and spread the message of the societal value of these agents.
“This is not a quick and casual drug evaluation” that produces “knockoff drugs,” but a “careful and extensive” FDA review that results in drugs that are equivalent in efficacy, safety, and immunogenicity to the reference drug and only compete on price, he explained.
When Pfizer began marketing Inflectra last Fall, it set the drug’s list price 15% lower than the list price at the time for Remicade, the reference-product infliximab. However, complex pricing and rebate strategies actually led to Remicade selling for a lower price than Inflectra, at least for some U.S. hospitals, including the University of Massachusetts in Worcester, where Dr. Kay is a professor of medicine.
“The effect of biosimilars is to reduce the cost to patients of an effective treatment. Whether that cost is for the reference drug or for the biosimilar drug doesn’t matter [from society’s perspective] as long as patients are able to receive an effective therapy at a [more] affordable cost, making the effective therapy available to more patients,” he said.
While Inflectra’s price impact my have been modest so far, the biosimilar effect on infliximab’s cost may soon intensify now that a second biosimilar of this TNFi, Renflexis – made by Samsung Bioepis and with U.S. marketing by Merck, received FDA approval on April 21, 2017. Until recently, U.S. pharmaceutical regulations had been understood to require a 180-day hiatus between FDA marketing approval for a biosimilar and the start of U.S. sales. But, on June 12, 2017, the U.S. Supreme Court, in a 9-0 decision, ruled that this 180-day wait was not required, making it possible for U.S. marketing of Renflexis to begin soon. (In mid-June, a statement on the Merck U.S. website for Renflexis says that the product is not currently available.)
Availability of a second biosimilar infliximab “is likely to drive the price down rapidly,” predicted Dr. Kay, citing what happened when multiple biosimilars for a reference drug came onto the European market.
Two other biosimilar TNFi have also received FDA marketing approvals but remain on hold as patent issues and litigation barriers play out. Erelzi – biosimilar etanercept – received FDA approval in August 2016, and Amjevita, biosimilar adalimumab, received FDA approval last September.
The efficacy and safety of Inflectra specifically, and by extension all biosimilars, received a recent boost with publication of findings from a randomized study with 482 patients that provided a real-world test of the core principle of biosimilar equivalence. After Inflectra came onto the Norwegian market, during July 2014 to August 2015, Norwegian researchers ran the NOR-SWTICH trial, which randomized patients who were on stable treatment with Remicade for a variety of indications (including 41% with a rheumatologic disease) to either stay on Remicade or to abruptly switch to treatment with Inflectra. During 1-year follow-up, the incidence of adverse effects and of episodes of disease worsening were virtually identical in the two treatment arms (Lancet. 2017 June 10;389[10086]:2304-16).
Dr. Kay has been a consultant to several companies that develop or market biosimilars, including Samsung Bioepis, Amgen, Pfizer, and Sandoz (Novartis), and to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Janssen, Roche, 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
EXPERT ANALYSIS FROM THE EULAR 2017 CONGRESS
Sacroiliac structural changes show on MRI in nonradiographic axial SpA despite no inflammation
Structural lesions of the sacroiliac joints (SIJ) may be present on MRI in patients with nonradiographic axial spondyloarthritis (nr-axSpA), even when radiographs are normal or inconclusive for such lesions and there is no evidence of inflammation on MRI, according to findings from a cohort of patients in a randomized trial.
In the study, the patients who exhibited such lesions, especially erosions, were more likely to have more severe disease and greater spinal inflammation than were patients who did not have the structural lesions on MRI.
The presence of MRI structural lesions appeared to reflect more severe disease with greater spinal inflammation, the investigators said, based on higher mean SPARCC spinal scores in 23 discovertebral units. The mean number of discovertebral units involved was significantly greater overall among patients with structural lesions (6.5), compared with those without (3.3). Both Bath Ankylosing Spondylitis Activity Index and Bath Ankylosing Spondylitis Functional Index scores were also significantly higher for patients with BME but no MRI structural lesions (a mean of 6.4 cm and 4.6 cm, respectively), when compared with patients who had both (a mean of 5.7 cm and 3.7 cm, respectively).
Age, sex, and HLA-B27 status also appeared to play a role in the frequency with which MRI structural lesions coexisted with BME. The group of patients with both BME and structural lesions in the sacroiliac joint were significantly more often male (83% vs. 48%), younger (mean age of 30 vs. 34 years), and HLA-B27 positive (87% vs. 63%) than in those with only BME.
“These data support the concept that nr-axSpA is an early stage of axSpA and that structural lesions in the SIJ are associated with a more severe phenotype characterized by more active spinal inflammation,” the investigators wrote.
The presence of structural lesions might also identify patients who would benefit the most from early treatment with biologics, they suggested. “It has been suggested that there is a window of opportunity for disease modification with anti-inflammatory agents by treating acute inflammatory lesions before bone formation pathways are triggered in more complex inflammatory lesions. Consequently, the presence of structural lesions in the SIJ may help select patients for intervention with anti-TNF agents early in the disease course.”
The study was funded by Pfizer. Three of the authors are employees of Pfizer. Two authors have received consulting fees and/or research funding/grants from a variety of companies that make drugs for the treatment of ankylosing spondylitis, including Pfizer.
Structural lesions of the sacroiliac joints (SIJ) may be present on MRI in patients with nonradiographic axial spondyloarthritis (nr-axSpA), even when radiographs are normal or inconclusive for such lesions and there is no evidence of inflammation on MRI, according to findings from a cohort of patients in a randomized trial.
In the study, the patients who exhibited such lesions, especially erosions, were more likely to have more severe disease and greater spinal inflammation than were patients who did not have the structural lesions on MRI.
The presence of MRI structural lesions appeared to reflect more severe disease with greater spinal inflammation, the investigators said, based on higher mean SPARCC spinal scores in 23 discovertebral units. The mean number of discovertebral units involved was significantly greater overall among patients with structural lesions (6.5), compared with those without (3.3). Both Bath Ankylosing Spondylitis Activity Index and Bath Ankylosing Spondylitis Functional Index scores were also significantly higher for patients with BME but no MRI structural lesions (a mean of 6.4 cm and 4.6 cm, respectively), when compared with patients who had both (a mean of 5.7 cm and 3.7 cm, respectively).
Age, sex, and HLA-B27 status also appeared to play a role in the frequency with which MRI structural lesions coexisted with BME. The group of patients with both BME and structural lesions in the sacroiliac joint were significantly more often male (83% vs. 48%), younger (mean age of 30 vs. 34 years), and HLA-B27 positive (87% vs. 63%) than in those with only BME.
“These data support the concept that nr-axSpA is an early stage of axSpA and that structural lesions in the SIJ are associated with a more severe phenotype characterized by more active spinal inflammation,” the investigators wrote.
The presence of structural lesions might also identify patients who would benefit the most from early treatment with biologics, they suggested. “It has been suggested that there is a window of opportunity for disease modification with anti-inflammatory agents by treating acute inflammatory lesions before bone formation pathways are triggered in more complex inflammatory lesions. Consequently, the presence of structural lesions in the SIJ may help select patients for intervention with anti-TNF agents early in the disease course.”
The study was funded by Pfizer. Three of the authors are employees of Pfizer. Two authors have received consulting fees and/or research funding/grants from a variety of companies that make drugs for the treatment of ankylosing spondylitis, including Pfizer.
Structural lesions of the sacroiliac joints (SIJ) may be present on MRI in patients with nonradiographic axial spondyloarthritis (nr-axSpA), even when radiographs are normal or inconclusive for such lesions and there is no evidence of inflammation on MRI, according to findings from a cohort of patients in a randomized trial.
In the study, the patients who exhibited such lesions, especially erosions, were more likely to have more severe disease and greater spinal inflammation than were patients who did not have the structural lesions on MRI.
The presence of MRI structural lesions appeared to reflect more severe disease with greater spinal inflammation, the investigators said, based on higher mean SPARCC spinal scores in 23 discovertebral units. The mean number of discovertebral units involved was significantly greater overall among patients with structural lesions (6.5), compared with those without (3.3). Both Bath Ankylosing Spondylitis Activity Index and Bath Ankylosing Spondylitis Functional Index scores were also significantly higher for patients with BME but no MRI structural lesions (a mean of 6.4 cm and 4.6 cm, respectively), when compared with patients who had both (a mean of 5.7 cm and 3.7 cm, respectively).
Age, sex, and HLA-B27 status also appeared to play a role in the frequency with which MRI structural lesions coexisted with BME. The group of patients with both BME and structural lesions in the sacroiliac joint were significantly more often male (83% vs. 48%), younger (mean age of 30 vs. 34 years), and HLA-B27 positive (87% vs. 63%) than in those with only BME.
“These data support the concept that nr-axSpA is an early stage of axSpA and that structural lesions in the SIJ are associated with a more severe phenotype characterized by more active spinal inflammation,” the investigators wrote.
The presence of structural lesions might also identify patients who would benefit the most from early treatment with biologics, they suggested. “It has been suggested that there is a window of opportunity for disease modification with anti-inflammatory agents by treating acute inflammatory lesions before bone formation pathways are triggered in more complex inflammatory lesions. Consequently, the presence of structural lesions in the SIJ may help select patients for intervention with anti-TNF agents early in the disease course.”
The study was funded by Pfizer. Three of the authors are employees of Pfizer. Two authors have received consulting fees and/or research funding/grants from a variety of companies that make drugs for the treatment of ankylosing spondylitis, including Pfizer.
FROM ARTHRITIS RESEARCH & THERAPY
Key clinical point:
Major finding: Sacroiliac joint erosions on MRI occurred in 11% of patients who did not have bone marrow edema, which was significantly less than its occurrence in 45% of those with BME.
Data source: A study of 183 patients with nr-axSpA who had participated in a treatment trial.
Disclosures: The study was funded by Pfizer. Three of the authors are employees of Pfizer. Two authors have received consulting fees and/or research funding/grants from a variety of companies that make drugs for the treatment of ankylosing spondylitis, including Pfizer.
Long-term TNFi tapering possible for some with ankylosing spondylitis
BIRMINGHAM, ENGLAND – A proportion of patients with ankylosing spondylitis (AS) were able to remain on a reduced-dose regimen of a tumor necrosis factor inhibitor (TNFi) for almost 4 years, according to data from a small study presented at the British Society for Rheumatology annual conference.
In an extension of the ANSWERS (Ankylosing Spondylitis with Etanercept Regimens) trial, 4 of 12 patients receiving a once-weekly 25-mg dose of etanercept (Enbrel) had a sustained response as did 14 of 21 patients who remained on the usual once-weekly dose of 50 mg.
“Although a minority of patients maintained response to the lower dose of etanercept over the longer term, the costs savings are substantial,” said Lauren Steel and coauthors from the Norfolk and Norwich Hospitals NHS Foundation Trust in a poster presentation. Almost 18,000 pounds sterling ($23,000) could be saved per each patient who is able to stay on the lower dose for 50 months.
Further, patients who did not maintain a response on the lower dose were usually able to regain their responses when the higher dose therapy was reinstituted. On average, disease control was reestablished in three out of four patients within 14 months of reverting to standard therapy.
ANSWERS was an open-label, multicenter, randomized, pilot study that sought to determine if tapering the dose of etanercept from the recommended 50 mg to 25 mg was feasible in 47 patients with AS (J Rheumatol. 2015;42:1177–85). The premise was that dose tapering in patients who achieved a response would perhaps reduce the risk for side effects in the long term, as well as provide considerable cost savings.
About half of the patients studied achieved a response to full-dose etanercept and were able to reduce their dose. At 6 months, a clinical response was maintained by 52% of the patients taking 25 mg and 92% of the patients taking 50 mg (P = .003).
The current prospective extension of the study looked at the longer-term outcomes of the patients who successfully maintained a response to the lower dose of etanercept.
Maintenance of response was defined as no change in the primary outcome of a reduction of 50% or more or a fall of at least 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and at least a 2-unit reduction in spinal pain measured using a 10-point scale.
In all, 12 patients, 9 of them male, with a mean age of 52 years entered the extension study. The comparator group consisted of 21 patients who had continued taking the 50-mg dose, 20 of them male, with a mean age of 60 years.
Of the 12 patients in the 25-mg group, 1 discontinued treatment because of side effects and did not restart any further biologic treatment; 7 patients experienced a disease flare after a median of 16 months and were retreated with the 50-mg dose. Five of the seven patients who reverted to the higher dose of etanercept regained a good response; the other two patients were switched to adalimumab (Humira) because of a loss of efficacy.
Pfizer funded the original study. One author disclosed he had received research funding and acted as an adviser to Pfizer and other pharmaceutical companies.
BIRMINGHAM, ENGLAND – A proportion of patients with ankylosing spondylitis (AS) were able to remain on a reduced-dose regimen of a tumor necrosis factor inhibitor (TNFi) for almost 4 years, according to data from a small study presented at the British Society for Rheumatology annual conference.
In an extension of the ANSWERS (Ankylosing Spondylitis with Etanercept Regimens) trial, 4 of 12 patients receiving a once-weekly 25-mg dose of etanercept (Enbrel) had a sustained response as did 14 of 21 patients who remained on the usual once-weekly dose of 50 mg.
“Although a minority of patients maintained response to the lower dose of etanercept over the longer term, the costs savings are substantial,” said Lauren Steel and coauthors from the Norfolk and Norwich Hospitals NHS Foundation Trust in a poster presentation. Almost 18,000 pounds sterling ($23,000) could be saved per each patient who is able to stay on the lower dose for 50 months.
Further, patients who did not maintain a response on the lower dose were usually able to regain their responses when the higher dose therapy was reinstituted. On average, disease control was reestablished in three out of four patients within 14 months of reverting to standard therapy.
ANSWERS was an open-label, multicenter, randomized, pilot study that sought to determine if tapering the dose of etanercept from the recommended 50 mg to 25 mg was feasible in 47 patients with AS (J Rheumatol. 2015;42:1177–85). The premise was that dose tapering in patients who achieved a response would perhaps reduce the risk for side effects in the long term, as well as provide considerable cost savings.
About half of the patients studied achieved a response to full-dose etanercept and were able to reduce their dose. At 6 months, a clinical response was maintained by 52% of the patients taking 25 mg and 92% of the patients taking 50 mg (P = .003).
The current prospective extension of the study looked at the longer-term outcomes of the patients who successfully maintained a response to the lower dose of etanercept.
Maintenance of response was defined as no change in the primary outcome of a reduction of 50% or more or a fall of at least 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and at least a 2-unit reduction in spinal pain measured using a 10-point scale.
In all, 12 patients, 9 of them male, with a mean age of 52 years entered the extension study. The comparator group consisted of 21 patients who had continued taking the 50-mg dose, 20 of them male, with a mean age of 60 years.
Of the 12 patients in the 25-mg group, 1 discontinued treatment because of side effects and did not restart any further biologic treatment; 7 patients experienced a disease flare after a median of 16 months and were retreated with the 50-mg dose. Five of the seven patients who reverted to the higher dose of etanercept regained a good response; the other two patients were switched to adalimumab (Humira) because of a loss of efficacy.
Pfizer funded the original study. One author disclosed he had received research funding and acted as an adviser to Pfizer and other pharmaceutical companies.
BIRMINGHAM, ENGLAND – A proportion of patients with ankylosing spondylitis (AS) were able to remain on a reduced-dose regimen of a tumor necrosis factor inhibitor (TNFi) for almost 4 years, according to data from a small study presented at the British Society for Rheumatology annual conference.
In an extension of the ANSWERS (Ankylosing Spondylitis with Etanercept Regimens) trial, 4 of 12 patients receiving a once-weekly 25-mg dose of etanercept (Enbrel) had a sustained response as did 14 of 21 patients who remained on the usual once-weekly dose of 50 mg.
“Although a minority of patients maintained response to the lower dose of etanercept over the longer term, the costs savings are substantial,” said Lauren Steel and coauthors from the Norfolk and Norwich Hospitals NHS Foundation Trust in a poster presentation. Almost 18,000 pounds sterling ($23,000) could be saved per each patient who is able to stay on the lower dose for 50 months.
Further, patients who did not maintain a response on the lower dose were usually able to regain their responses when the higher dose therapy was reinstituted. On average, disease control was reestablished in three out of four patients within 14 months of reverting to standard therapy.
ANSWERS was an open-label, multicenter, randomized, pilot study that sought to determine if tapering the dose of etanercept from the recommended 50 mg to 25 mg was feasible in 47 patients with AS (J Rheumatol. 2015;42:1177–85). The premise was that dose tapering in patients who achieved a response would perhaps reduce the risk for side effects in the long term, as well as provide considerable cost savings.
About half of the patients studied achieved a response to full-dose etanercept and were able to reduce their dose. At 6 months, a clinical response was maintained by 52% of the patients taking 25 mg and 92% of the patients taking 50 mg (P = .003).
The current prospective extension of the study looked at the longer-term outcomes of the patients who successfully maintained a response to the lower dose of etanercept.
Maintenance of response was defined as no change in the primary outcome of a reduction of 50% or more or a fall of at least 2 units in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and at least a 2-unit reduction in spinal pain measured using a 10-point scale.
In all, 12 patients, 9 of them male, with a mean age of 52 years entered the extension study. The comparator group consisted of 21 patients who had continued taking the 50-mg dose, 20 of them male, with a mean age of 60 years.
Of the 12 patients in the 25-mg group, 1 discontinued treatment because of side effects and did not restart any further biologic treatment; 7 patients experienced a disease flare after a median of 16 months and were retreated with the 50-mg dose. Five of the seven patients who reverted to the higher dose of etanercept regained a good response; the other two patients were switched to adalimumab (Humira) because of a loss of efficacy.
Pfizer funded the original study. One author disclosed he had received research funding and acted as an adviser to Pfizer and other pharmaceutical companies.
AT RHEUMATOLOGY 2017
Key clinical point:
Major finding: Four of 12 patients treated with etanercept 25 mg once weekly maintained a response at 50 months.
Data source: An extension study of 33 patients in the open-label, multicenter, randomized Ankylosing Spondylitis with Etanercept Regimens (ANSWERS) trial.
Disclosures: Pfizer funded the original study. One author disclosed he had received research funding and acted as an adviser to Pfizer and other pharmaceutical companies.
Ankylosing spondylitis disease severity worsened by smoking
BIRMINGHAM, ENGLAND – Patients with axial spondyloarthritis who currently smoke have been found to have worse disease activity than those who do not in an early analysis of data from the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS).
Smoking was associated with worse disease not only when comparing ever smokers with never smokers, but also when current smokers were compared to ex-smokers, and there was some evidence that the amount of smoking was important with heavier smokers having worse disease activity than light smokers.
Dr. Zhao, of Aintree University Hospital in Liverpool, England, added that, as in previous studies, these data show that “smoking is associated with worse disease activity at baseline and this needs to be accounted for in the next stage of longitudinal analysis.”
An association between smoking and worse disease activity in patients with axSpA has been reported previously, Dr. Zhao acknowledged, but this is not as clear cut as in rheumatoid arthritis where smoking is known to have a pathogenic effect. The small number of earlier studies looking at the possible effect of smoking in AS have been limited by their size and varying methodology, he added, and the studies’ researchers were not able to see if there was any potential dose effect of smoking.
The BSRBR-AS, which started recruiting patients with an Assessment of SpondyloArthritis international Society (ASAS) classification of axSpA in 2012, offers a unique opportunity to explore the association between smoking and axSpA further, he said. More than 2,500 patients are included in the register at present, none of whom should have not been treated with biologic agents at the time of recruitment.
The aim of the present analysis that looked at data on 932 patients was to quantify the effect of smoking status and quantity on several disease outcomes as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Spinal pain was also assessed, by way of a visual analog scale (VAS), and quality of life was determined via the disease-specific Ankylosing Spondylitis Quality of Life Instruments (ASQoL).
Most of the patients recruited were male (71%), and the mean age was 50 years. HLA-B27 data were available for 64% of the cohort, and 84% were positive.
Self-reported smoking status was recorded, with 19% saying they were current smokers, 37% saying they were ex-smokers, and 44% saying they had never smoked. If patients reported being ever smokers, the frequency with which they smoked (daily, weekly, monthly, once or twice, or never) was recorded, and if patients smoked daily, then the number of cigarettes smoked per day was obtained. Heavy smoking was defined as smoking 10 or more cigarettes per day and light smoking as fewer than 10 cigarettes per day. By this definition, around 37% of daily smokers were classed as heavy smokers.
In a comparison of ever smokers with never smokers, the mean BASDAI, BASFI, BASMI, spinal VAS, and ASQoL were significantly higher if patients had smoked at some point. All comparisons were adjusted for age, gender, body mass index, and HLA-B27 status.
The mean BASDAI score, for example, was more than 1 unit higher in a comparison of ever smokers with never smokers, with an adjusted regression coefficient of 1.04 and a 95% confidence interval (CI) of 0.72-1.36.
The adjusted regression coefficients for the other measures assessed were 1.34 (95% CI, 0.98-1.69) for BASFI, 0.61 (95% CI 0.36-0.87) for BASMI, 1.11 (95% CI, 0.74-1.49) for spinal VAS, and 2.71 (95% CI, 2.01–3.41) for ASQoL.
Similar findings were seen in the analysis comparing current with ex-smokers across all measures studied, and there was a trend for disease activity to be worse in heavier than in lighter smokers. The latter may not have reached significance because of the smaller number of patients (n = 172) involved in that part of the analysis. Nevertheless, these preliminary findings suggest that even being a light smoker can affect disease outcomes and so cutting down (i.e., to fewer than 10 cigarettes per day) may not be sufficient to reduce the effect that smoking has on disease activity.
“We should be actively encouraging our patients [with axSpA] to stop smoking,” Dr. Zhao concluded.
The BSRBR-AS is managed by a team of investigators based at the University of Aberdeen in collaboration with 83 centers throughout the United Kingdom. It is funded by the BSR, which in turn receives funding from the manufacturers of the biologic therapies included in this study (currently AbbVie, Pfizer, and UCB). Dr. Zhao and coauthors had no conflicts of interest to disclose.
BIRMINGHAM, ENGLAND – Patients with axial spondyloarthritis who currently smoke have been found to have worse disease activity than those who do not in an early analysis of data from the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS).
Smoking was associated with worse disease not only when comparing ever smokers with never smokers, but also when current smokers were compared to ex-smokers, and there was some evidence that the amount of smoking was important with heavier smokers having worse disease activity than light smokers.
Dr. Zhao, of Aintree University Hospital in Liverpool, England, added that, as in previous studies, these data show that “smoking is associated with worse disease activity at baseline and this needs to be accounted for in the next stage of longitudinal analysis.”
An association between smoking and worse disease activity in patients with axSpA has been reported previously, Dr. Zhao acknowledged, but this is not as clear cut as in rheumatoid arthritis where smoking is known to have a pathogenic effect. The small number of earlier studies looking at the possible effect of smoking in AS have been limited by their size and varying methodology, he added, and the studies’ researchers were not able to see if there was any potential dose effect of smoking.
The BSRBR-AS, which started recruiting patients with an Assessment of SpondyloArthritis international Society (ASAS) classification of axSpA in 2012, offers a unique opportunity to explore the association between smoking and axSpA further, he said. More than 2,500 patients are included in the register at present, none of whom should have not been treated with biologic agents at the time of recruitment.
The aim of the present analysis that looked at data on 932 patients was to quantify the effect of smoking status and quantity on several disease outcomes as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Spinal pain was also assessed, by way of a visual analog scale (VAS), and quality of life was determined via the disease-specific Ankylosing Spondylitis Quality of Life Instruments (ASQoL).
Most of the patients recruited were male (71%), and the mean age was 50 years. HLA-B27 data were available for 64% of the cohort, and 84% were positive.
Self-reported smoking status was recorded, with 19% saying they were current smokers, 37% saying they were ex-smokers, and 44% saying they had never smoked. If patients reported being ever smokers, the frequency with which they smoked (daily, weekly, monthly, once or twice, or never) was recorded, and if patients smoked daily, then the number of cigarettes smoked per day was obtained. Heavy smoking was defined as smoking 10 or more cigarettes per day and light smoking as fewer than 10 cigarettes per day. By this definition, around 37% of daily smokers were classed as heavy smokers.
In a comparison of ever smokers with never smokers, the mean BASDAI, BASFI, BASMI, spinal VAS, and ASQoL were significantly higher if patients had smoked at some point. All comparisons were adjusted for age, gender, body mass index, and HLA-B27 status.
The mean BASDAI score, for example, was more than 1 unit higher in a comparison of ever smokers with never smokers, with an adjusted regression coefficient of 1.04 and a 95% confidence interval (CI) of 0.72-1.36.
The adjusted regression coefficients for the other measures assessed were 1.34 (95% CI, 0.98-1.69) for BASFI, 0.61 (95% CI 0.36-0.87) for BASMI, 1.11 (95% CI, 0.74-1.49) for spinal VAS, and 2.71 (95% CI, 2.01–3.41) for ASQoL.
Similar findings were seen in the analysis comparing current with ex-smokers across all measures studied, and there was a trend for disease activity to be worse in heavier than in lighter smokers. The latter may not have reached significance because of the smaller number of patients (n = 172) involved in that part of the analysis. Nevertheless, these preliminary findings suggest that even being a light smoker can affect disease outcomes and so cutting down (i.e., to fewer than 10 cigarettes per day) may not be sufficient to reduce the effect that smoking has on disease activity.
“We should be actively encouraging our patients [with axSpA] to stop smoking,” Dr. Zhao concluded.
The BSRBR-AS is managed by a team of investigators based at the University of Aberdeen in collaboration with 83 centers throughout the United Kingdom. It is funded by the BSR, which in turn receives funding from the manufacturers of the biologic therapies included in this study (currently AbbVie, Pfizer, and UCB). Dr. Zhao and coauthors had no conflicts of interest to disclose.
BIRMINGHAM, ENGLAND – Patients with axial spondyloarthritis who currently smoke have been found to have worse disease activity than those who do not in an early analysis of data from the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS).
Smoking was associated with worse disease not only when comparing ever smokers with never smokers, but also when current smokers were compared to ex-smokers, and there was some evidence that the amount of smoking was important with heavier smokers having worse disease activity than light smokers.
Dr. Zhao, of Aintree University Hospital in Liverpool, England, added that, as in previous studies, these data show that “smoking is associated with worse disease activity at baseline and this needs to be accounted for in the next stage of longitudinal analysis.”
An association between smoking and worse disease activity in patients with axSpA has been reported previously, Dr. Zhao acknowledged, but this is not as clear cut as in rheumatoid arthritis where smoking is known to have a pathogenic effect. The small number of earlier studies looking at the possible effect of smoking in AS have been limited by their size and varying methodology, he added, and the studies’ researchers were not able to see if there was any potential dose effect of smoking.
The BSRBR-AS, which started recruiting patients with an Assessment of SpondyloArthritis international Society (ASAS) classification of axSpA in 2012, offers a unique opportunity to explore the association between smoking and axSpA further, he said. More than 2,500 patients are included in the register at present, none of whom should have not been treated with biologic agents at the time of recruitment.
The aim of the present analysis that looked at data on 932 patients was to quantify the effect of smoking status and quantity on several disease outcomes as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Spinal pain was also assessed, by way of a visual analog scale (VAS), and quality of life was determined via the disease-specific Ankylosing Spondylitis Quality of Life Instruments (ASQoL).
Most of the patients recruited were male (71%), and the mean age was 50 years. HLA-B27 data were available for 64% of the cohort, and 84% were positive.
Self-reported smoking status was recorded, with 19% saying they were current smokers, 37% saying they were ex-smokers, and 44% saying they had never smoked. If patients reported being ever smokers, the frequency with which they smoked (daily, weekly, monthly, once or twice, or never) was recorded, and if patients smoked daily, then the number of cigarettes smoked per day was obtained. Heavy smoking was defined as smoking 10 or more cigarettes per day and light smoking as fewer than 10 cigarettes per day. By this definition, around 37% of daily smokers were classed as heavy smokers.
In a comparison of ever smokers with never smokers, the mean BASDAI, BASFI, BASMI, spinal VAS, and ASQoL were significantly higher if patients had smoked at some point. All comparisons were adjusted for age, gender, body mass index, and HLA-B27 status.
The mean BASDAI score, for example, was more than 1 unit higher in a comparison of ever smokers with never smokers, with an adjusted regression coefficient of 1.04 and a 95% confidence interval (CI) of 0.72-1.36.
The adjusted regression coefficients for the other measures assessed were 1.34 (95% CI, 0.98-1.69) for BASFI, 0.61 (95% CI 0.36-0.87) for BASMI, 1.11 (95% CI, 0.74-1.49) for spinal VAS, and 2.71 (95% CI, 2.01–3.41) for ASQoL.
Similar findings were seen in the analysis comparing current with ex-smokers across all measures studied, and there was a trend for disease activity to be worse in heavier than in lighter smokers. The latter may not have reached significance because of the smaller number of patients (n = 172) involved in that part of the analysis. Nevertheless, these preliminary findings suggest that even being a light smoker can affect disease outcomes and so cutting down (i.e., to fewer than 10 cigarettes per day) may not be sufficient to reduce the effect that smoking has on disease activity.
“We should be actively encouraging our patients [with axSpA] to stop smoking,” Dr. Zhao concluded.
The BSRBR-AS is managed by a team of investigators based at the University of Aberdeen in collaboration with 83 centers throughout the United Kingdom. It is funded by the BSR, which in turn receives funding from the manufacturers of the biologic therapies included in this study (currently AbbVie, Pfizer, and UCB). Dr. Zhao and coauthors had no conflicts of interest to disclose.
AT RHEUMATOLOGY 2017
Key clinical point:
Major finding: Mean BASDAI, BASFI, BASMI, spinal VAS, and ASQoL were all significantly higher in ever vs. never smokers.
Data source: The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS).
Disclosures: The BSRBR-AS is managed by a team of investigators based at the University of Aberdeen in collaboration with 83 centers throughout the United Kingdom. It is funded by the BSR, which in turn receives funding from the manufacturers of the biologic therapies included in this study (currently AbbVie, Pfizer, and UCB). Dr. Zhao and coauthors had no conflicts of interest to disclose.