Spondyloarthropathies

MADRID – In axial spondyloarthritis patients who discontinue a tumor necrosis factor inhibitor (TNFi), there does not appear to be any advantage for using the anti–interleukin-17 biologic secukinumab over a different tumor necrosis factor inhibitor for next therapy, according to an analysis presented at the European Congress of Rheumatology.

Ted Bosworth/MDedge News

“Switching to secukinumab [Cosentyx] might even be inferior in many patients,” according to Adrian Ciurea, MD, of the clinic for rheumatology at University Hospital Zürich.

This conclusion was reached in a retrospective analysis of axial spondyloarthritis (axSpA) patients enrolled in the Swiss Clinical Quality Management Cohort. Although Dr. Ciurea said that a prospective trial is needed to confirm the findings, this study was conducted because there have been, up until now, “no data to choose between options” to guide this choice.

In this study of 382 axSpA patients who were candidates for a new biologic after discontinuing a previous TNFi, 275 were started on a different TNFi and 107 were started on secukinumab. Although about 60% of patients in both groups were HLAB27-positive, there were many other characteristics, including those related to disease severity, that were different, Dr. Ciurea acknowledged.

Specifically, the proportion of patients starting secukinumab treated with two or more TNF inhibitors was greater than that of patients switching to another TNFi (77.6% vs. 37.8%; P less than .001). In addition, patients in the secukinumab group had a higher baseline disease activity, more enthesitis, and greater axial impairment.

These were reflected in higher average Bath Ankylosing Spondylitis Disease Activity Index scores (6.1 vs. 4.8; P less than .001) as well as other baseline clinical scoring methods, such as the Bath Ankylosing Spondylitis Functional Index and the Maastricht Ankylosing Spondylitis Enthesitis Score.

However, baseline high-sensitivity C-reactive protein levels, number of swollen joints, or years of symptom duration were not significantly different between the groups, although all were numerically higher in the secukinumab group. The proportion of patients with uveitis was higher in the TNFi group. About 70% of patients in both groups had discontinued their prior TNFi for inadequate response.

For the primary assessment of drug survival on the new therapy, the median time was 1.1 years in the secukinumab group and 2.0 years in the group switched to a new TNFi, without adjustment for baseline characteristics and disease severity. After risk adjustment, this difference was no statistically significant.

“There was an interaction with gender, indicating a significantly higher risk of discontinuing secukinumab than a new TNFi in men,” according to Dr. Ciurea. This was not seen in women.

Previous studies have shown the response rate to a second TNFi is typically lower than for an initial TNFi therapy. Previous studies have also shown that response to secukinumab is lower in patients with previous TNFi experience than in those who are naive to biologics, Dr. Ciurea said. This analysis suggests that the likelihood of sustained disease control is not greater in TNFi-experienced patients who start secukinumab relative to a different TNFi.

When asked if the data had been analyzed to compare response in patients exposed to only one prior TNFi, Dr. Ciurea replied that this could not be done because the sample size was too small.

Although Dr. Ciurea acknowledged the limitations of retrospective studies with risk adjustments, he concluded that there does not appear to be an advantage for initiating secukinumab over starting a different TNFi in axSpA patients who require a switch from their current TNFi,

Even though he said that this is the first study to address this question objectively, Dr. Ciurea said, “A sufficiently powered, prospective, head-to-head trial is needed.”

Dr. Ciurea reported multiple financial relationships with pharmaceutical companies but received no funding for this study.

SOURCE: Tellenbach C et al. Ann Rheum Dis. 2019;78(Suppl 2):197. Abstract OPO237, doi: 10.1136/annrheumdis-2019-eular.2427

MADRID – In axial spondyloarthritis patients who discontinue a tumor necrosis factor inhibitor (TNFi), there does not appear to be any advantage for using the anti–interleukin-17 biologic secukinumab over a different tumor necrosis factor inhibitor for next therapy, according to an analysis presented at the European Congress of Rheumatology.

Ted Bosworth/MDedge News

“Switching to secukinumab [Cosentyx] might even be inferior in many patients,” according to Adrian Ciurea, MD, of the clinic for rheumatology at University Hospital Zürich.

This conclusion was reached in a retrospective analysis of axial spondyloarthritis (axSpA) patients enrolled in the Swiss Clinical Quality Management Cohort. Although Dr. Ciurea said that a prospective trial is needed to confirm the findings, this study was conducted because there have been, up until now, “no data to choose between options” to guide this choice.

In this study of 382 axSpA patients who were candidates for a new biologic after discontinuing a previous TNFi, 275 were started on a different TNFi and 107 were started on secukinumab. Although about 60% of patients in both groups were HLAB27-positive, there were many other characteristics, including those related to disease severity, that were different, Dr. Ciurea acknowledged.

Specifically, the proportion of patients starting secukinumab treated with two or more TNF inhibitors was greater than that of patients switching to another TNFi (77.6% vs. 37.8%; P less than .001). In addition, patients in the secukinumab group had a higher baseline disease activity, more enthesitis, and greater axial impairment.

These were reflected in higher average Bath Ankylosing Spondylitis Disease Activity Index scores (6.1 vs. 4.8; P less than .001) as well as other baseline clinical scoring methods, such as the Bath Ankylosing Spondylitis Functional Index and the Maastricht Ankylosing Spondylitis Enthesitis Score.

However, baseline high-sensitivity C-reactive protein levels, number of swollen joints, or years of symptom duration were not significantly different between the groups, although all were numerically higher in the secukinumab group. The proportion of patients with uveitis was higher in the TNFi group. About 70% of patients in both groups had discontinued their prior TNFi for inadequate response.

For the primary assessment of drug survival on the new therapy, the median time was 1.1 years in the secukinumab group and 2.0 years in the group switched to a new TNFi, without adjustment for baseline characteristics and disease severity. After risk adjustment, this difference was no statistically significant.

“There was an interaction with gender, indicating a significantly higher risk of discontinuing secukinumab than a new TNFi in men,” according to Dr. Ciurea. This was not seen in women.

Previous studies have shown the response rate to a second TNFi is typically lower than for an initial TNFi therapy. Previous studies have also shown that response to secukinumab is lower in patients with previous TNFi experience than in those who are naive to biologics, Dr. Ciurea said. This analysis suggests that the likelihood of sustained disease control is not greater in TNFi-experienced patients who start secukinumab relative to a different TNFi.

When asked if the data had been analyzed to compare response in patients exposed to only one prior TNFi, Dr. Ciurea replied that this could not be done because the sample size was too small.

Although Dr. Ciurea acknowledged the limitations of retrospective studies with risk adjustments, he concluded that there does not appear to be an advantage for initiating secukinumab over starting a different TNFi in axSpA patients who require a switch from their current TNFi,

Even though he said that this is the first study to address this question objectively, Dr. Ciurea said, “A sufficiently powered, prospective, head-to-head trial is needed.”

Dr. Ciurea reported multiple financial relationships with pharmaceutical companies but received no funding for this study.

SOURCE: Tellenbach C et al. Ann Rheum Dis. 2019;78(Suppl 2):197. Abstract OPO237, doi: 10.1136/annrheumdis-2019-eular.2427

MADRID – In axial spondyloarthritis patients who discontinue a tumor necrosis factor inhibitor (TNFi), there does not appear to be any advantage for using the anti–interleukin-17 biologic secukinumab over a different tumor necrosis factor inhibitor for next therapy, according to an analysis presented at the European Congress of Rheumatology.

Ted Bosworth/MDedge News

“Switching to secukinumab [Cosentyx] might even be inferior in many patients,” according to Adrian Ciurea, MD, of the clinic for rheumatology at University Hospital Zürich.

This conclusion was reached in a retrospective analysis of axial spondyloarthritis (axSpA) patients enrolled in the Swiss Clinical Quality Management Cohort. Although Dr. Ciurea said that a prospective trial is needed to confirm the findings, this study was conducted because there have been, up until now, “no data to choose between options” to guide this choice.

In this study of 382 axSpA patients who were candidates for a new biologic after discontinuing a previous TNFi, 275 were started on a different TNFi and 107 were started on secukinumab. Although about 60% of patients in both groups were HLAB27-positive, there were many other characteristics, including those related to disease severity, that were different, Dr. Ciurea acknowledged.

Specifically, the proportion of patients starting secukinumab treated with two or more TNF inhibitors was greater than that of patients switching to another TNFi (77.6% vs. 37.8%; P less than .001). In addition, patients in the secukinumab group had a higher baseline disease activity, more enthesitis, and greater axial impairment.

These were reflected in higher average Bath Ankylosing Spondylitis Disease Activity Index scores (6.1 vs. 4.8; P less than .001) as well as other baseline clinical scoring methods, such as the Bath Ankylosing Spondylitis Functional Index and the Maastricht Ankylosing Spondylitis Enthesitis Score.

However, baseline high-sensitivity C-reactive protein levels, number of swollen joints, or years of symptom duration were not significantly different between the groups, although all were numerically higher in the secukinumab group. The proportion of patients with uveitis was higher in the TNFi group. About 70% of patients in both groups had discontinued their prior TNFi for inadequate response.

For the primary assessment of drug survival on the new therapy, the median time was 1.1 years in the secukinumab group and 2.0 years in the group switched to a new TNFi, without adjustment for baseline characteristics and disease severity. After risk adjustment, this difference was no statistically significant.

“There was an interaction with gender, indicating a significantly higher risk of discontinuing secukinumab than a new TNFi in men,” according to Dr. Ciurea. This was not seen in women.

Previous studies have shown the response rate to a second TNFi is typically lower than for an initial TNFi therapy. Previous studies have also shown that response to secukinumab is lower in patients with previous TNFi experience than in those who are naive to biologics, Dr. Ciurea said. This analysis suggests that the likelihood of sustained disease control is not greater in TNFi-experienced patients who start secukinumab relative to a different TNFi.

When asked if the data had been analyzed to compare response in patients exposed to only one prior TNFi, Dr. Ciurea replied that this could not be done because the sample size was too small.

Although Dr. Ciurea acknowledged the limitations of retrospective studies with risk adjustments, he concluded that there does not appear to be an advantage for initiating secukinumab over starting a different TNFi in axSpA patients who require a switch from their current TNFi,

Even though he said that this is the first study to address this question objectively, Dr. Ciurea said, “A sufficiently powered, prospective, head-to-head trial is needed.”

Dr. Ciurea reported multiple financial relationships with pharmaceutical companies but received no funding for this study.

SOURCE: Tellenbach C et al. Ann Rheum Dis. 2019;78(Suppl 2):197. Abstract OPO237, doi: 10.1136/annrheumdis-2019-eular.2427

MADRID – Trial results presented at the European Congress of Rheumatology for three anti–interleukin-17 receptor monoclonal antibodies under investigation for the treatment of axial spondyloarthritis (axSpA), including one for ankylosing spondylitis (AS), appear to support further clinical development and regulatory review to potentially join secukinumab (Cosentyx) and ixekizumab (Taltz) as the only IL-17 inhibitors to be licensed for rheumatic diseases.

Both netakimab and brodalumab (Siliq) achieved positive results in separate phase 3 trials for the treatment of axSpA, while new data from a phase 2b trial of bimekizumab was associated with improvement in the quality of life of patients with AS. Brodalumab is already approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis.
 

Netakimab

Ted Bosworth/MDedge News

The multinational, double-blind, phase 3 trial with netakimab, called the ASTERA trial, randomized 228 patients with radiographic axSpA to either 120 mg of the experimental agent or placebo, each administered subcutaneously in weekly doses in the first 2 weeks and then every other week thereafter. The primary endpoint was a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) at week 16.

A larger proportion of patients in the netakimab arm met the primary endpoint, compared with those in the placebo arm (40.4% vs. 2.63%, respectively; P less than .0001), reported Inna Gaydukova, MD, of Mechnikov North-Western State Medical University, St. Petersburg, Russia.

“Most of the secondary efficacy endpoints also showed a significant advantage for netakimab relative to placebo by week 4, and these advantages remained significant for the remainder of the study,” she said.

The one serious adverse event in the study occurred in the placebo arm. Although mild to moderate anemia and neutropenia were associated with treatment, the drug was well tolerated overall.

“We did observe a significant reduction in inflammatory activity in the spine with MRI at week 16,” Dr. Gaydukova added. Functional improvements in the experimental arm relative to the placebo arm were also observed, although Dr. Gaydukova acknowledged that longer trials are needed to show that these benefits are durable.
 

Brodalumab

The results of a multinational, double-blind, phase 3 trial with brodalumab proved similar to those with netakimab. Conducted in Taiwan, Japan, and South Korea, the trial randomized 159 patients to 210 mg of brodalumab or placebo administered subcutaneously. The therapies were administered on the same schedule as in the netakimab trial. The primary outcome was also the same.

At week 16, 43.8% of those on the experimental agent versus 24.1% of those randomized to placebo achieved ASAS40 (P = .018). As in the netakimab study, greater activity with brodalumab than placebo was also seen on several secondary outcomes, such as ASAS20 (67.5% vs. 41.8%).

“In a subgroup analysis, there was an advantage for brodalumab over placebo whether or not patients had prior experience with a TNF [tumor necrosis factor] inhibitor, regardless of baseline hs-CRP [high sensitivity C-reactive protein] level and independent of HLA type,” reported James Cheng-Chung Wei, MD, of Chung Shan Medical University Hospital, Taichung, Taiwan.

There were no significant differences in the types or rates of adverse events, including serious adverse events, in patients assigned to brodalumab relative to placebo. Suicide ideation, which has been associated with some biologics targeting other immunologic mediators, was evaluated but not seen.

“We think brodalumab has the potential to be a new therapeutic option in axSpA,” said Dr. Wei, who reported that studies in AS are also planned.
 

Bimekizumab

Additional 12-week outcome data from the multinational, double-blind, phase 2b BE AGILE trial of bimekizumab in patients with active AS were presented by Désirée van der Heijde, MD, PhD, of Leiden (the Netherlands) University Medical Center.

Unlike secukinumab and most of the other anti–IL-17 receptor monoclonal antibodies in development, bimekizumab inhibits IL-17F in addition to IL-17A, according to Dr. van der Heijde. She cited experimental evidence suggesting that inhibition of both forms of IL-17 results in greater anti-inflammatory response.

In the initial and previously reported data from this dose-ranging study of 303 AS patients, all four doses of bimekizumab (16 mg, 64 mg, 160 mg, or 320 mg) were superior to placebo for the primary endpoint of ASAS40. However, greater relative benefit was observed for the three highest doses.

In the new analysis, symptoms were evaluated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). At 12 weeks, 47.5% of patients on the highest dose of bimekizumab versus only 11.9% of patients randomized to placebo achieved a 50% or greater level of improvement on the BASDAI, called BASDAI 50 (P less than .001).

The greater clinical activity of bimekizumab relative to placebo translated into improvement from baseline in Ankylosing Spondylitis Quality of Life scores. Greater reductions in Ankylosing Spondylitis Quality of Life scores relative to placebo, signaling an improved quality of life, were achieved with all doses, but they reached 4.6 points for the highest dose versus only 1.3 for placebo.

When evaluated with Patient Global Assessment of Disease Activity, another tool that reflects perception of disease burden, the score reduction was 3.3 points for the highest dose versus 1.0 points for placebo. Dr. van der Heijde characterized the reductions at the highest doses versus placebo as “significant” although she did not provide P values.

Like the data presented on the other newer anti–IL-17 therapies, bimekizumab was well tolerated with relatively low rates of adverse events, most of which were mild to moderate in severity, according to Dr. van der Heijde.

“The data from the BE AGILE trial supports phase 3 development in AS,” Dr. van der Heijde said. She noted that trials are also being planned in axSpA.

All three presenting authors reported multiple financial relationships with pharmaceutical companies, including, in each case, the pharmaceutical company that sponsored the trial they presented.

SOURCES: Gaydukova I et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193-4, Abstract OP0232. doi: 10.1136/annrheumdis-2019-eular.6633; Wei JC et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):195, Abstract OP0234. doi: 10.1136/annrheumdis-2019-eular.6888; van der Heijde D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193, Abstract OP0231. doi: 10.1136/annrheumdis-2019-eular.6607.

MADRID – Trial results presented at the European Congress of Rheumatology for three anti–interleukin-17 receptor monoclonal antibodies under investigation for the treatment of axial spondyloarthritis (axSpA), including one for ankylosing spondylitis (AS), appear to support further clinical development and regulatory review to potentially join secukinumab (Cosentyx) and ixekizumab (Taltz) as the only IL-17 inhibitors to be licensed for rheumatic diseases.

Both netakimab and brodalumab (Siliq) achieved positive results in separate phase 3 trials for the treatment of axSpA, while new data from a phase 2b trial of bimekizumab was associated with improvement in the quality of life of patients with AS. Brodalumab is already approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis.
 

Netakimab

Ted Bosworth/MDedge News

The multinational, double-blind, phase 3 trial with netakimab, called the ASTERA trial, randomized 228 patients with radiographic axSpA to either 120 mg of the experimental agent or placebo, each administered subcutaneously in weekly doses in the first 2 weeks and then every other week thereafter. The primary endpoint was a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) at week 16.

A larger proportion of patients in the netakimab arm met the primary endpoint, compared with those in the placebo arm (40.4% vs. 2.63%, respectively; P less than .0001), reported Inna Gaydukova, MD, of Mechnikov North-Western State Medical University, St. Petersburg, Russia.

“Most of the secondary efficacy endpoints also showed a significant advantage for netakimab relative to placebo by week 4, and these advantages remained significant for the remainder of the study,” she said.

The one serious adverse event in the study occurred in the placebo arm. Although mild to moderate anemia and neutropenia were associated with treatment, the drug was well tolerated overall.

“We did observe a significant reduction in inflammatory activity in the spine with MRI at week 16,” Dr. Gaydukova added. Functional improvements in the experimental arm relative to the placebo arm were also observed, although Dr. Gaydukova acknowledged that longer trials are needed to show that these benefits are durable.
 

Brodalumab

The results of a multinational, double-blind, phase 3 trial with brodalumab proved similar to those with netakimab. Conducted in Taiwan, Japan, and South Korea, the trial randomized 159 patients to 210 mg of brodalumab or placebo administered subcutaneously. The therapies were administered on the same schedule as in the netakimab trial. The primary outcome was also the same.

At week 16, 43.8% of those on the experimental agent versus 24.1% of those randomized to placebo achieved ASAS40 (P = .018). As in the netakimab study, greater activity with brodalumab than placebo was also seen on several secondary outcomes, such as ASAS20 (67.5% vs. 41.8%).

“In a subgroup analysis, there was an advantage for brodalumab over placebo whether or not patients had prior experience with a TNF [tumor necrosis factor] inhibitor, regardless of baseline hs-CRP [high sensitivity C-reactive protein] level and independent of HLA type,” reported James Cheng-Chung Wei, MD, of Chung Shan Medical University Hospital, Taichung, Taiwan.

There were no significant differences in the types or rates of adverse events, including serious adverse events, in patients assigned to brodalumab relative to placebo. Suicide ideation, which has been associated with some biologics targeting other immunologic mediators, was evaluated but not seen.

“We think brodalumab has the potential to be a new therapeutic option in axSpA,” said Dr. Wei, who reported that studies in AS are also planned.
 

Bimekizumab

Additional 12-week outcome data from the multinational, double-blind, phase 2b BE AGILE trial of bimekizumab in patients with active AS were presented by Désirée van der Heijde, MD, PhD, of Leiden (the Netherlands) University Medical Center.

Unlike secukinumab and most of the other anti–IL-17 receptor monoclonal antibodies in development, bimekizumab inhibits IL-17F in addition to IL-17A, according to Dr. van der Heijde. She cited experimental evidence suggesting that inhibition of both forms of IL-17 results in greater anti-inflammatory response.

In the initial and previously reported data from this dose-ranging study of 303 AS patients, all four doses of bimekizumab (16 mg, 64 mg, 160 mg, or 320 mg) were superior to placebo for the primary endpoint of ASAS40. However, greater relative benefit was observed for the three highest doses.

In the new analysis, symptoms were evaluated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). At 12 weeks, 47.5% of patients on the highest dose of bimekizumab versus only 11.9% of patients randomized to placebo achieved a 50% or greater level of improvement on the BASDAI, called BASDAI 50 (P less than .001).

The greater clinical activity of bimekizumab relative to placebo translated into improvement from baseline in Ankylosing Spondylitis Quality of Life scores. Greater reductions in Ankylosing Spondylitis Quality of Life scores relative to placebo, signaling an improved quality of life, were achieved with all doses, but they reached 4.6 points for the highest dose versus only 1.3 for placebo.

When evaluated with Patient Global Assessment of Disease Activity, another tool that reflects perception of disease burden, the score reduction was 3.3 points for the highest dose versus 1.0 points for placebo. Dr. van der Heijde characterized the reductions at the highest doses versus placebo as “significant” although she did not provide P values.

Like the data presented on the other newer anti–IL-17 therapies, bimekizumab was well tolerated with relatively low rates of adverse events, most of which were mild to moderate in severity, according to Dr. van der Heijde.

“The data from the BE AGILE trial supports phase 3 development in AS,” Dr. van der Heijde said. She noted that trials are also being planned in axSpA.

All three presenting authors reported multiple financial relationships with pharmaceutical companies, including, in each case, the pharmaceutical company that sponsored the trial they presented.

SOURCES: Gaydukova I et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193-4, Abstract OP0232. doi: 10.1136/annrheumdis-2019-eular.6633; Wei JC et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):195, Abstract OP0234. doi: 10.1136/annrheumdis-2019-eular.6888; van der Heijde D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193, Abstract OP0231. doi: 10.1136/annrheumdis-2019-eular.6607.

MADRID – Trial results presented at the European Congress of Rheumatology for three anti–interleukin-17 receptor monoclonal antibodies under investigation for the treatment of axial spondyloarthritis (axSpA), including one for ankylosing spondylitis (AS), appear to support further clinical development and regulatory review to potentially join secukinumab (Cosentyx) and ixekizumab (Taltz) as the only IL-17 inhibitors to be licensed for rheumatic diseases.

Both netakimab and brodalumab (Siliq) achieved positive results in separate phase 3 trials for the treatment of axSpA, while new data from a phase 2b trial of bimekizumab was associated with improvement in the quality of life of patients with AS. Brodalumab is already approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis.
 

Netakimab

Ted Bosworth/MDedge News

The multinational, double-blind, phase 3 trial with netakimab, called the ASTERA trial, randomized 228 patients with radiographic axSpA to either 120 mg of the experimental agent or placebo, each administered subcutaneously in weekly doses in the first 2 weeks and then every other week thereafter. The primary endpoint was a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) at week 16.

A larger proportion of patients in the netakimab arm met the primary endpoint, compared with those in the placebo arm (40.4% vs. 2.63%, respectively; P less than .0001), reported Inna Gaydukova, MD, of Mechnikov North-Western State Medical University, St. Petersburg, Russia.

“Most of the secondary efficacy endpoints also showed a significant advantage for netakimab relative to placebo by week 4, and these advantages remained significant for the remainder of the study,” she said.

The one serious adverse event in the study occurred in the placebo arm. Although mild to moderate anemia and neutropenia were associated with treatment, the drug was well tolerated overall.

“We did observe a significant reduction in inflammatory activity in the spine with MRI at week 16,” Dr. Gaydukova added. Functional improvements in the experimental arm relative to the placebo arm were also observed, although Dr. Gaydukova acknowledged that longer trials are needed to show that these benefits are durable.
 

Brodalumab

The results of a multinational, double-blind, phase 3 trial with brodalumab proved similar to those with netakimab. Conducted in Taiwan, Japan, and South Korea, the trial randomized 159 patients to 210 mg of brodalumab or placebo administered subcutaneously. The therapies were administered on the same schedule as in the netakimab trial. The primary outcome was also the same.

At week 16, 43.8% of those on the experimental agent versus 24.1% of those randomized to placebo achieved ASAS40 (P = .018). As in the netakimab study, greater activity with brodalumab than placebo was also seen on several secondary outcomes, such as ASAS20 (67.5% vs. 41.8%).

“In a subgroup analysis, there was an advantage for brodalumab over placebo whether or not patients had prior experience with a TNF [tumor necrosis factor] inhibitor, regardless of baseline hs-CRP [high sensitivity C-reactive protein] level and independent of HLA type,” reported James Cheng-Chung Wei, MD, of Chung Shan Medical University Hospital, Taichung, Taiwan.

There were no significant differences in the types or rates of adverse events, including serious adverse events, in patients assigned to brodalumab relative to placebo. Suicide ideation, which has been associated with some biologics targeting other immunologic mediators, was evaluated but not seen.

“We think brodalumab has the potential to be a new therapeutic option in axSpA,” said Dr. Wei, who reported that studies in AS are also planned.
 

Bimekizumab

Additional 12-week outcome data from the multinational, double-blind, phase 2b BE AGILE trial of bimekizumab in patients with active AS were presented by Désirée van der Heijde, MD, PhD, of Leiden (the Netherlands) University Medical Center.

Unlike secukinumab and most of the other anti–IL-17 receptor monoclonal antibodies in development, bimekizumab inhibits IL-17F in addition to IL-17A, according to Dr. van der Heijde. She cited experimental evidence suggesting that inhibition of both forms of IL-17 results in greater anti-inflammatory response.

In the initial and previously reported data from this dose-ranging study of 303 AS patients, all four doses of bimekizumab (16 mg, 64 mg, 160 mg, or 320 mg) were superior to placebo for the primary endpoint of ASAS40. However, greater relative benefit was observed for the three highest doses.

In the new analysis, symptoms were evaluated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). At 12 weeks, 47.5% of patients on the highest dose of bimekizumab versus only 11.9% of patients randomized to placebo achieved a 50% or greater level of improvement on the BASDAI, called BASDAI 50 (P less than .001).

The greater clinical activity of bimekizumab relative to placebo translated into improvement from baseline in Ankylosing Spondylitis Quality of Life scores. Greater reductions in Ankylosing Spondylitis Quality of Life scores relative to placebo, signaling an improved quality of life, were achieved with all doses, but they reached 4.6 points for the highest dose versus only 1.3 for placebo.

When evaluated with Patient Global Assessment of Disease Activity, another tool that reflects perception of disease burden, the score reduction was 3.3 points for the highest dose versus 1.0 points for placebo. Dr. van der Heijde characterized the reductions at the highest doses versus placebo as “significant” although she did not provide P values.

Like the data presented on the other newer anti–IL-17 therapies, bimekizumab was well tolerated with relatively low rates of adverse events, most of which were mild to moderate in severity, according to Dr. van der Heijde.

“The data from the BE AGILE trial supports phase 3 development in AS,” Dr. van der Heijde said. She noted that trials are also being planned in axSpA.

All three presenting authors reported multiple financial relationships with pharmaceutical companies, including, in each case, the pharmaceutical company that sponsored the trial they presented.

SOURCES: Gaydukova I et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193-4, Abstract OP0232. doi: 10.1136/annrheumdis-2019-eular.6633; Wei JC et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):195, Abstract OP0234. doi: 10.1136/annrheumdis-2019-eular.6888; van der Heijde D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193, Abstract OP0231. doi: 10.1136/annrheumdis-2019-eular.6607.

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Referral, treatment, and rapid access to care are three of nine new quality standards developed by a multidisciplinary task force of the Assessment of SpondyloArthritis international Society (ASAS) with the aim of improving the management of adults with axial spondyloarthritis (axSpA).

The other quality standards look at how to improve patient education and self-management and call for annual review, Uta Kiltz, MD, said at the European Congress of Rheumatology.

Sara Freeman/MDedge News

“Several unmet needs such as delayed diagnosis and restricted access to treatment have been described in patients with axSpA worldwide,” Dr. Kiltz observed in an interview. Results from the ASAS-COMOSPA study (Ann Rheum Dis. 2018;77[3]:405-11), for example, highlighted inequity in the prescription of biologic disease-modifying antirheumatic drugs across the globe.

“The variation in quality of care is noted across rheumatologic diseases,” said Dr. Kiltz, of Ruhr University Bochum and Rheumazentrum Ruhrgebiet in Herne, Germany. “Assessing the quality of care provided to patients with axSpA is important not only to patients and physicians, but also to providers and purchasers of health care.”

A major goal of ASAS is to improve quality of care and health outcomes in patients with axSpA. To address the many gaps in current care, the society set out to develop quality standards to optimize patients’ access to care and their overall treatment.

“A quality standard consists of a quality statement accompanied by a measure. The measure can be used to assess the quality of care or service provision specified in the treatment,” Dr. Kiltz explained.

Quality standards are very different from recommendations or guidelines, she stressed. While the latter imply evidence-based actions that should be done to optimally diagnose and treat the disease, quality standards identify resources or processes that need to be optimized in high-priority areas for quality improvement.

The nine ASAS quality standards cover key areas for quality improvement relating to the care of adults with axSpA that need improvement worldwide. The statements were carefully phrased following a consensus, and the tools by which they could be measured agreed.

The first three standards concern the time to referral from primary to specialist care and state that people with a suspicion of axSpA are referred to a rheumatologist within 3 working days, assessed by a rheumatologist within 3 weeks after referral, and have their diagnostic work up completed within 2 months.

The next two quality standards concern pharmacologic management: Disease activity of people with axSpA is monitored under the supervision of a rheumatologist with validated composite scores at least twice a year, and in people with axSpA and active disease despite conventional therapy, treatment escalation to biologics is discussed.

Nonpharmacologic treatment is also covered, with the sixth quality standard stating: “People with axial SpA are informed about the benefits of regular exercise.”

Quality standard 7 states: “People with axSpA are offered education on the disease including self-management within 2 months of diagnosis,” Dr. Kiltz said. Rapid access to care is the focus of quality statement 8: “People with axSpA and disease flare or possible drug-related side effects receive advice within 2 working days of contacting the rheumatologist.”

The ninth and last quality standard states that people with axSpA should have a comprehensive annual review by a rheumatologist.

“These are the first quality standards applicable worldwide for the improvement of health care for adult patients with axSpA,” Dr. Kiltz said. “The ASAS quality standards are all measurable and achievable and are intended to minimize variation in quality of care.”

Dr. Kiltz had no relevant conflicts of interest.

SOURCE: Kiltz U. Ann Rheum Dis. Jun 2019;78(Suppl 2):1-2. Abstract SP0004, doi: 10.1136/annrheumdis-2019-eular.8514.

MADRID – Referral, treatment, and rapid access to care are three of nine new quality standards developed by a multidisciplinary task force of the Assessment of SpondyloArthritis international Society (ASAS) with the aim of improving the management of adults with axial spondyloarthritis (axSpA).

The other quality standards look at how to improve patient education and self-management and call for annual review, Uta Kiltz, MD, said at the European Congress of Rheumatology.

Sara Freeman/MDedge News

“Several unmet needs such as delayed diagnosis and restricted access to treatment have been described in patients with axSpA worldwide,” Dr. Kiltz observed in an interview. Results from the ASAS-COMOSPA study (Ann Rheum Dis. 2018;77[3]:405-11), for example, highlighted inequity in the prescription of biologic disease-modifying antirheumatic drugs across the globe.

“The variation in quality of care is noted across rheumatologic diseases,” said Dr. Kiltz, of Ruhr University Bochum and Rheumazentrum Ruhrgebiet in Herne, Germany. “Assessing the quality of care provided to patients with axSpA is important not only to patients and physicians, but also to providers and purchasers of health care.”

A major goal of ASAS is to improve quality of care and health outcomes in patients with axSpA. To address the many gaps in current care, the society set out to develop quality standards to optimize patients’ access to care and their overall treatment.

“A quality standard consists of a quality statement accompanied by a measure. The measure can be used to assess the quality of care or service provision specified in the treatment,” Dr. Kiltz explained.

Quality standards are very different from recommendations or guidelines, she stressed. While the latter imply evidence-based actions that should be done to optimally diagnose and treat the disease, quality standards identify resources or processes that need to be optimized in high-priority areas for quality improvement.

The nine ASAS quality standards cover key areas for quality improvement relating to the care of adults with axSpA that need improvement worldwide. The statements were carefully phrased following a consensus, and the tools by which they could be measured agreed.

The first three standards concern the time to referral from primary to specialist care and state that people with a suspicion of axSpA are referred to a rheumatologist within 3 working days, assessed by a rheumatologist within 3 weeks after referral, and have their diagnostic work up completed within 2 months.

The next two quality standards concern pharmacologic management: Disease activity of people with axSpA is monitored under the supervision of a rheumatologist with validated composite scores at least twice a year, and in people with axSpA and active disease despite conventional therapy, treatment escalation to biologics is discussed.

Nonpharmacologic treatment is also covered, with the sixth quality standard stating: “People with axial SpA are informed about the benefits of regular exercise.”

Quality standard 7 states: “People with axSpA are offered education on the disease including self-management within 2 months of diagnosis,” Dr. Kiltz said. Rapid access to care is the focus of quality statement 8: “People with axSpA and disease flare or possible drug-related side effects receive advice within 2 working days of contacting the rheumatologist.”

The ninth and last quality standard states that people with axSpA should have a comprehensive annual review by a rheumatologist.

“These are the first quality standards applicable worldwide for the improvement of health care for adult patients with axSpA,” Dr. Kiltz said. “The ASAS quality standards are all measurable and achievable and are intended to minimize variation in quality of care.”

Dr. Kiltz had no relevant conflicts of interest.

SOURCE: Kiltz U. Ann Rheum Dis. Jun 2019;78(Suppl 2):1-2. Abstract SP0004, doi: 10.1136/annrheumdis-2019-eular.8514.

MADRID – Referral, treatment, and rapid access to care are three of nine new quality standards developed by a multidisciplinary task force of the Assessment of SpondyloArthritis international Society (ASAS) with the aim of improving the management of adults with axial spondyloarthritis (axSpA).

The other quality standards look at how to improve patient education and self-management and call for annual review, Uta Kiltz, MD, said at the European Congress of Rheumatology.

Sara Freeman/MDedge News

“Several unmet needs such as delayed diagnosis and restricted access to treatment have been described in patients with axSpA worldwide,” Dr. Kiltz observed in an interview. Results from the ASAS-COMOSPA study (Ann Rheum Dis. 2018;77[3]:405-11), for example, highlighted inequity in the prescription of biologic disease-modifying antirheumatic drugs across the globe.

“The variation in quality of care is noted across rheumatologic diseases,” said Dr. Kiltz, of Ruhr University Bochum and Rheumazentrum Ruhrgebiet in Herne, Germany. “Assessing the quality of care provided to patients with axSpA is important not only to patients and physicians, but also to providers and purchasers of health care.”

A major goal of ASAS is to improve quality of care and health outcomes in patients with axSpA. To address the many gaps in current care, the society set out to develop quality standards to optimize patients’ access to care and their overall treatment.

“A quality standard consists of a quality statement accompanied by a measure. The measure can be used to assess the quality of care or service provision specified in the treatment,” Dr. Kiltz explained.

Quality standards are very different from recommendations or guidelines, she stressed. While the latter imply evidence-based actions that should be done to optimally diagnose and treat the disease, quality standards identify resources or processes that need to be optimized in high-priority areas for quality improvement.

The nine ASAS quality standards cover key areas for quality improvement relating to the care of adults with axSpA that need improvement worldwide. The statements were carefully phrased following a consensus, and the tools by which they could be measured agreed.

The first three standards concern the time to referral from primary to specialist care and state that people with a suspicion of axSpA are referred to a rheumatologist within 3 working days, assessed by a rheumatologist within 3 weeks after referral, and have their diagnostic work up completed within 2 months.

The next two quality standards concern pharmacologic management: Disease activity of people with axSpA is monitored under the supervision of a rheumatologist with validated composite scores at least twice a year, and in people with axSpA and active disease despite conventional therapy, treatment escalation to biologics is discussed.

Nonpharmacologic treatment is also covered, with the sixth quality standard stating: “People with axial SpA are informed about the benefits of regular exercise.”

Quality standard 7 states: “People with axSpA are offered education on the disease including self-management within 2 months of diagnosis,” Dr. Kiltz said. Rapid access to care is the focus of quality statement 8: “People with axSpA and disease flare or possible drug-related side effects receive advice within 2 working days of contacting the rheumatologist.”

The ninth and last quality standard states that people with axSpA should have a comprehensive annual review by a rheumatologist.

“These are the first quality standards applicable worldwide for the improvement of health care for adult patients with axSpA,” Dr. Kiltz said. “The ASAS quality standards are all measurable and achievable and are intended to minimize variation in quality of care.”

Dr. Kiltz had no relevant conflicts of interest.

SOURCE: Kiltz U. Ann Rheum Dis. Jun 2019;78(Suppl 2):1-2. Abstract SP0004, doi: 10.1136/annrheumdis-2019-eular.8514.

MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.

“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.

As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.


Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.

Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.

Order imaging relevant to treatment decisions

Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.

Ted Bosworth/MDedge News

“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.

“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.

Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
 

Clinical and imaging findings better then imaging alone

Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.

In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.

A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.

In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.

Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.

“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.

However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.

One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.

SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027

MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.

“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.

As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.


Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.

Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.

Order imaging relevant to treatment decisions

Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.

Ted Bosworth/MDedge News

“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.

“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.

Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
 

Clinical and imaging findings better then imaging alone

Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.

In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.

A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.

In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.

Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.

“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.

However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.

One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.

SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027

MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.

“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.

As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.


Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.

Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.

Order imaging relevant to treatment decisions

Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.

Ted Bosworth/MDedge News

“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.

“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.

Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
 

Clinical and imaging findings better then imaging alone

Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.

In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.

A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.

In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.

Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.

“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.

However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.

One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.

SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027

MADRID – Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

MADRID – Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

MADRID – Patients achieve comparable long-term control of spondyloarthritis on biosimilars as they do on the originator biologic drug, judging from data drawn from registries in five Scandinavian countries in a study that evaluated retention rates after 1 year of therapy.

Bente Glintborg, MD, PhD, from the Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, explains in a video interview that the indication provided to biosimilars for spondyloarthritis was extended from comparisons conducted in rheumatoid arthritis (RA).

In the absence of a randomized trial in spondyloarthritis, she suggested that this comparison might be the best opportunity to evaluate whether biosimilars perform as well as their biologic originator. This is an important aim based on the theoretical possibility that equivalence in RA does not translate into equivalence in other rheumatic conditions where biologics are indicated.

As she explains, 1,015 biologic-naïve patients initiating etanercept, a tumor necrosis factor (TNF) inhibitor, or a biosimilar were assessed at baseline and at the end of 1 year of therapy. The patients were enrolled in biologic registries maintained in Denmark, Finland, Iceland, Norway, or Sweden.

Retention rates at 1 year were numerically lower on etanercept than the biosimilars, but the difference was not significant (66% vs. 73%; P = 0.18). There also were no significant differences between the biosimilars and etanercept when disease activity was compared at 6 months.

Retention rates are a reasonable surrogate for both efficacy and tolerability based on the expectation that more patients would switch or discontinue agents in the event of lack of efficacy or unacceptable side effects, Dr. Glintborg said at the European Congress of Rheumatology.

In this interview, she notes that a similar study from the Nordic registries led by a coinvestigator also showed equivalent retention rates among spondyloarthritis patients when biosimilars and infliximab were compared at 2 years.

Dr. Glintborg received research support from Biogen, Pfizer, and Abbievie.

MADRID – Treating patients with axial spondyloarthritis (axSpA) until a specific target is reached is an emerging concept that has gained a lot of traction in the past few years, Pedro Machado, MD, said at the European Congress of Rheumatology.

Vidyard Video

“The availability of biologic therapies has improved the clinical outcomes for our patients with axial spondyloarthritis and targeting clinical remission or inactive disease is now an achievable treatment goal in clinical practice,” he observed. “This has trigged the question: Is there a role for ‘treat-to-target’ in axial spondyloarthritis?”

Dr. Machado, an honorary consultant in rheumatology and muscle diseases at University College Hospital and the National Hospital for Neurology and Neurosurgery in London, took a critical look at the treat-to-target approach during a clinical science session at the meeting, organized by the European League Against Rheumatism (EULAR).

The concept of treat-to-target is not new, he acknowledged, having been imported from other chronic conditions where there is a very specific target to achieve – such as lowering glycated hemoglobin in diabetes or hypertension or hyperlipidemia in cardiovascular disease.

“The concept involves changing or escalating therapy according to a predefined target under the assumption that this may lead to a better outcome compared to what we call ‘routine care,’ ” Dr. Machado explained.

Treat-to-target is not only well established in nonrheumatic diseases but also has proved to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Whether the approach can also work in axSpA is open to debate, and one of the main arguments against using a treat-to-target in axSpA asks, what exactly is the target? While there is no firm agreement yet, Dr. Machado observed that achieving either clinical remission or inactive disease would be the most likely target.

It could be argued this is already being done to some degree, but “we need to be more ambitious,” Dr. Machado said. Indeed, current Assessment of Spondyloarthritis International Society/EULAR recommendations for the treatment of axSpA (Ann Rheum Dis. 2017;76[6]:978–91) note when patients with high disease activity despite sufficient standard treatment should be escalated to treatment with a biologic disease-modifying antirheumatic drug (bDMARD). High disease activity was defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or more or a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more.

Another argument against using the approach concerns the evidence base. There are no prospective, randomized trials supporting the use of treat-to-target over routine care. However, there is a lot of observational evidence, Dr. Machado said in an interview. Such studies have shown that achieving inactive disease may improve structural outcomes and stop the development of radiographic damage of the spine. Importantly, these observational studies also show that achieving inactive disease may also help to improve patients’ functional outcomes and quality of life.

Evidence backing a treat-to-target approach in axSpA from a randomized, controlled trial may currently be lacking, but the TiCOSPA (Tight Control in Spondyloarthritis) trial is in progress and should help change that, Dr. Machado said.

“The missing bit is a randomized trial, but I would say that the observational evidence is almost enough to advocate a treat-to-target strategy in axial spondyloarthritis.” This was also the view of an international task force that recently published recommendations and overarching principles for a treat-target strategy in spondyloarthritis, including axSpA (Ann Rheum Dis. 2018;77:3-17).

Of course, a treat-to-target approach may not be without its pitfalls. There are a limited number of drugs currently that could be used to “hit the target” of disease activity, Dr. Machado said in his presentation. The approach might also lead to ‘overtreatment,’ and more treatment is not always better as it could not only lead to more adverse events, but it also may mean the approach is not cost-effective.

Depending on the TiCOSPA study results, which are expected next year, Dr. Machado said that “the feasibility and cost-effectiveness of such a strategy in clinical practice also needs to be tested.”

MADRID – Treating patients with axial spondyloarthritis (axSpA) until a specific target is reached is an emerging concept that has gained a lot of traction in the past few years, Pedro Machado, MD, said at the European Congress of Rheumatology.

Vidyard Video

“The availability of biologic therapies has improved the clinical outcomes for our patients with axial spondyloarthritis and targeting clinical remission or inactive disease is now an achievable treatment goal in clinical practice,” he observed. “This has trigged the question: Is there a role for ‘treat-to-target’ in axial spondyloarthritis?”

Dr. Machado, an honorary consultant in rheumatology and muscle diseases at University College Hospital and the National Hospital for Neurology and Neurosurgery in London, took a critical look at the treat-to-target approach during a clinical science session at the meeting, organized by the European League Against Rheumatism (EULAR).

The concept of treat-to-target is not new, he acknowledged, having been imported from other chronic conditions where there is a very specific target to achieve – such as lowering glycated hemoglobin in diabetes or hypertension or hyperlipidemia in cardiovascular disease.

“The concept involves changing or escalating therapy according to a predefined target under the assumption that this may lead to a better outcome compared to what we call ‘routine care,’ ” Dr. Machado explained.

Treat-to-target is not only well established in nonrheumatic diseases but also has proved to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Whether the approach can also work in axSpA is open to debate, and one of the main arguments against using a treat-to-target in axSpA asks, what exactly is the target? While there is no firm agreement yet, Dr. Machado observed that achieving either clinical remission or inactive disease would be the most likely target.

It could be argued this is already being done to some degree, but “we need to be more ambitious,” Dr. Machado said. Indeed, current Assessment of Spondyloarthritis International Society/EULAR recommendations for the treatment of axSpA (Ann Rheum Dis. 2017;76[6]:978–91) note when patients with high disease activity despite sufficient standard treatment should be escalated to treatment with a biologic disease-modifying antirheumatic drug (bDMARD). High disease activity was defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or more or a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more.

Another argument against using the approach concerns the evidence base. There are no prospective, randomized trials supporting the use of treat-to-target over routine care. However, there is a lot of observational evidence, Dr. Machado said in an interview. Such studies have shown that achieving inactive disease may improve structural outcomes and stop the development of radiographic damage of the spine. Importantly, these observational studies also show that achieving inactive disease may also help to improve patients’ functional outcomes and quality of life.

Evidence backing a treat-to-target approach in axSpA from a randomized, controlled trial may currently be lacking, but the TiCOSPA (Tight Control in Spondyloarthritis) trial is in progress and should help change that, Dr. Machado said.

“The missing bit is a randomized trial, but I would say that the observational evidence is almost enough to advocate a treat-to-target strategy in axial spondyloarthritis.” This was also the view of an international task force that recently published recommendations and overarching principles for a treat-target strategy in spondyloarthritis, including axSpA (Ann Rheum Dis. 2018;77:3-17).

Of course, a treat-to-target approach may not be without its pitfalls. There are a limited number of drugs currently that could be used to “hit the target” of disease activity, Dr. Machado said in his presentation. The approach might also lead to ‘overtreatment,’ and more treatment is not always better as it could not only lead to more adverse events, but it also may mean the approach is not cost-effective.

Depending on the TiCOSPA study results, which are expected next year, Dr. Machado said that “the feasibility and cost-effectiveness of such a strategy in clinical practice also needs to be tested.”

MADRID – Treating patients with axial spondyloarthritis (axSpA) until a specific target is reached is an emerging concept that has gained a lot of traction in the past few years, Pedro Machado, MD, said at the European Congress of Rheumatology.

Vidyard Video

“The availability of biologic therapies has improved the clinical outcomes for our patients with axial spondyloarthritis and targeting clinical remission or inactive disease is now an achievable treatment goal in clinical practice,” he observed. “This has trigged the question: Is there a role for ‘treat-to-target’ in axial spondyloarthritis?”

Dr. Machado, an honorary consultant in rheumatology and muscle diseases at University College Hospital and the National Hospital for Neurology and Neurosurgery in London, took a critical look at the treat-to-target approach during a clinical science session at the meeting, organized by the European League Against Rheumatism (EULAR).

The concept of treat-to-target is not new, he acknowledged, having been imported from other chronic conditions where there is a very specific target to achieve – such as lowering glycated hemoglobin in diabetes or hypertension or hyperlipidemia in cardiovascular disease.

“The concept involves changing or escalating therapy according to a predefined target under the assumption that this may lead to a better outcome compared to what we call ‘routine care,’ ” Dr. Machado explained.

Treat-to-target is not only well established in nonrheumatic diseases but also has proved to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Whether the approach can also work in axSpA is open to debate, and one of the main arguments against using a treat-to-target in axSpA asks, what exactly is the target? While there is no firm agreement yet, Dr. Machado observed that achieving either clinical remission or inactive disease would be the most likely target.

It could be argued this is already being done to some degree, but “we need to be more ambitious,” Dr. Machado said. Indeed, current Assessment of Spondyloarthritis International Society/EULAR recommendations for the treatment of axSpA (Ann Rheum Dis. 2017;76[6]:978–91) note when patients with high disease activity despite sufficient standard treatment should be escalated to treatment with a biologic disease-modifying antirheumatic drug (bDMARD). High disease activity was defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or more or a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more.

Another argument against using the approach concerns the evidence base. There are no prospective, randomized trials supporting the use of treat-to-target over routine care. However, there is a lot of observational evidence, Dr. Machado said in an interview. Such studies have shown that achieving inactive disease may improve structural outcomes and stop the development of radiographic damage of the spine. Importantly, these observational studies also show that achieving inactive disease may also help to improve patients’ functional outcomes and quality of life.

Evidence backing a treat-to-target approach in axSpA from a randomized, controlled trial may currently be lacking, but the TiCOSPA (Tight Control in Spondyloarthritis) trial is in progress and should help change that, Dr. Machado said.

“The missing bit is a randomized trial, but I would say that the observational evidence is almost enough to advocate a treat-to-target strategy in axial spondyloarthritis.” This was also the view of an international task force that recently published recommendations and overarching principles for a treat-target strategy in spondyloarthritis, including axSpA (Ann Rheum Dis. 2018;77:3-17).

Of course, a treat-to-target approach may not be without its pitfalls. There are a limited number of drugs currently that could be used to “hit the target” of disease activity, Dr. Machado said in his presentation. The approach might also lead to ‘overtreatment,’ and more treatment is not always better as it could not only lead to more adverse events, but it also may mean the approach is not cost-effective.

Depending on the TiCOSPA study results, which are expected next year, Dr. Machado said that “the feasibility and cost-effectiveness of such a strategy in clinical practice also needs to be tested.”

About a quarter of all patients with ankylosing spondylitis, and more than half of those patients who were on Medicaid, received at least a 90-day supply of opioids in a year, based on an analysis of U.S. commercial claims data.

sdominick/iStock/Getty Images

The findings were noted in 2012-2017 data from a cohort of 11,945 patients in the Truven Health MarketScan Research database. Of those patients given the International Classification of Diseases (ICD) code 720.0, which is specific for ankylosing spondylitis, 23.5% of patients chronically used opioids. In the broader 720.x commercial claims cohort of 79,190 patients, the proportion who chronically used opioids was 27.3%.

More than 60% of the patients who chronically used opioids had a cumulative drug supply of 270 days or more.

“Patients with ankylosing spondylitis receive opioids with disturbing frequency,” said study author Victor S. Sloan, MD, and research colleagues in the June issue of the Journal of Rheumatology. Ankylosing spondylitis treatment guidelines “specify use of an NSAID as initial pharmacotherapy, with anti-TNF [tumor necrosis factor] therapy in cases of NSAID inefficacy or intolerance. However, for many patients, prescription opioids – while not addressing the underlying inflammation – may offer an inexpensive and rapid means of achieving symptomatic relief.”

Patients who chronically used opioids were more likely to have depression (25.4% vs. 12.5%) and anxiety (20.9% vs. 11.7%) during the baseline period of the study. Patients with chronic opioid use also were more likely to receive muscle relaxants (54.4% vs. 20.2%) and oral corticosteroids (18.4% vs. 9.6%), compared with patients without chronic opioid use, reported Dr. Sloan, vice president and immunology development strategy lead for UCB Pharma and of the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., and colleagues.

Claims for anti-TNF therapies, disease-modifying antirheumatic drugs (DMARDs), and NSAIDs were similar for patients with and without chronic opioid use.

The patients in the study had claims with the specified diagnosis codes during Jan. 1, 2013–March 31, 2016 and were enrolled in medical and pharmacy benefits for 12 months before and after the first qualifying ICD code. The study excluded patients with a history of cancer other than nonmelanoma skin cancer. Opioid claims within 7 days of a hospitalization or 2 days of an emergency department or urgent care visit were not included.

The investigators assessed patients’ demographics, clinical characteristics, comorbidities, and prior treatments during a 12-month baseline period prior to the index date. They examined opioid use and exposure to other treatments during a 12-month follow-up period after the index date. They defined chronic opioid use as at least 90 cumulative days of opioid use based on the supply value on opioid pharmacy claims. They summed the days’ supply for all opioid claims during the follow-up period.

Chronic use of opioids was most pronounced in the 917 patients with Medicaid claims with 720.0 diagnosis codes; 57.1% chronically used opioids during follow-up. Among 14,041 patients with Medicaid claims with 720.x codes, 76.7% chronically used opioids.

The data suggest that some patients may receive opioids before they receive recommended therapies. “If this is the case, there may be an opportunity to prevent chronic opioid use by intervening with recommended therapies earlier in the patient’s treatment course,” the authors wrote.

Dr. Sloan and colleagues noted that they had limited information about the timing of opioid use relative to ankylosing spondylitis diagnosis, opioid potency and dose, and the indication for which opioids were prescribed.

UCB Pharma funded the study. The authors are employees of UCB Pharma.

[email protected]

SOURCE: Sloan VS et al. J Rheumatol. 2019 Jan 15. doi: 10.3899/jrheum.180972.

About a quarter of all patients with ankylosing spondylitis, and more than half of those patients who were on Medicaid, received at least a 90-day supply of opioids in a year, based on an analysis of U.S. commercial claims data.

sdominick/iStock/Getty Images

The findings were noted in 2012-2017 data from a cohort of 11,945 patients in the Truven Health MarketScan Research database. Of those patients given the International Classification of Diseases (ICD) code 720.0, which is specific for ankylosing spondylitis, 23.5% of patients chronically used opioids. In the broader 720.x commercial claims cohort of 79,190 patients, the proportion who chronically used opioids was 27.3%.

More than 60% of the patients who chronically used opioids had a cumulative drug supply of 270 days or more.

“Patients with ankylosing spondylitis receive opioids with disturbing frequency,” said study author Victor S. Sloan, MD, and research colleagues in the June issue of the Journal of Rheumatology. Ankylosing spondylitis treatment guidelines “specify use of an NSAID as initial pharmacotherapy, with anti-TNF [tumor necrosis factor] therapy in cases of NSAID inefficacy or intolerance. However, for many patients, prescription opioids – while not addressing the underlying inflammation – may offer an inexpensive and rapid means of achieving symptomatic relief.”

Patients who chronically used opioids were more likely to have depression (25.4% vs. 12.5%) and anxiety (20.9% vs. 11.7%) during the baseline period of the study. Patients with chronic opioid use also were more likely to receive muscle relaxants (54.4% vs. 20.2%) and oral corticosteroids (18.4% vs. 9.6%), compared with patients without chronic opioid use, reported Dr. Sloan, vice president and immunology development strategy lead for UCB Pharma and of the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., and colleagues.

Claims for anti-TNF therapies, disease-modifying antirheumatic drugs (DMARDs), and NSAIDs were similar for patients with and without chronic opioid use.

The patients in the study had claims with the specified diagnosis codes during Jan. 1, 2013–March 31, 2016 and were enrolled in medical and pharmacy benefits for 12 months before and after the first qualifying ICD code. The study excluded patients with a history of cancer other than nonmelanoma skin cancer. Opioid claims within 7 days of a hospitalization or 2 days of an emergency department or urgent care visit were not included.

The investigators assessed patients’ demographics, clinical characteristics, comorbidities, and prior treatments during a 12-month baseline period prior to the index date. They examined opioid use and exposure to other treatments during a 12-month follow-up period after the index date. They defined chronic opioid use as at least 90 cumulative days of opioid use based on the supply value on opioid pharmacy claims. They summed the days’ supply for all opioid claims during the follow-up period.

Chronic use of opioids was most pronounced in the 917 patients with Medicaid claims with 720.0 diagnosis codes; 57.1% chronically used opioids during follow-up. Among 14,041 patients with Medicaid claims with 720.x codes, 76.7% chronically used opioids.

The data suggest that some patients may receive opioids before they receive recommended therapies. “If this is the case, there may be an opportunity to prevent chronic opioid use by intervening with recommended therapies earlier in the patient’s treatment course,” the authors wrote.

Dr. Sloan and colleagues noted that they had limited information about the timing of opioid use relative to ankylosing spondylitis diagnosis, opioid potency and dose, and the indication for which opioids were prescribed.

UCB Pharma funded the study. The authors are employees of UCB Pharma.

[email protected]

SOURCE: Sloan VS et al. J Rheumatol. 2019 Jan 15. doi: 10.3899/jrheum.180972.

About a quarter of all patients with ankylosing spondylitis, and more than half of those patients who were on Medicaid, received at least a 90-day supply of opioids in a year, based on an analysis of U.S. commercial claims data.

sdominick/iStock/Getty Images

The findings were noted in 2012-2017 data from a cohort of 11,945 patients in the Truven Health MarketScan Research database. Of those patients given the International Classification of Diseases (ICD) code 720.0, which is specific for ankylosing spondylitis, 23.5% of patients chronically used opioids. In the broader 720.x commercial claims cohort of 79,190 patients, the proportion who chronically used opioids was 27.3%.

More than 60% of the patients who chronically used opioids had a cumulative drug supply of 270 days or more.

“Patients with ankylosing spondylitis receive opioids with disturbing frequency,” said study author Victor S. Sloan, MD, and research colleagues in the June issue of the Journal of Rheumatology. Ankylosing spondylitis treatment guidelines “specify use of an NSAID as initial pharmacotherapy, with anti-TNF [tumor necrosis factor] therapy in cases of NSAID inefficacy or intolerance. However, for many patients, prescription opioids – while not addressing the underlying inflammation – may offer an inexpensive and rapid means of achieving symptomatic relief.”

Patients who chronically used opioids were more likely to have depression (25.4% vs. 12.5%) and anxiety (20.9% vs. 11.7%) during the baseline period of the study. Patients with chronic opioid use also were more likely to receive muscle relaxants (54.4% vs. 20.2%) and oral corticosteroids (18.4% vs. 9.6%), compared with patients without chronic opioid use, reported Dr. Sloan, vice president and immunology development strategy lead for UCB Pharma and of the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., and colleagues.

Claims for anti-TNF therapies, disease-modifying antirheumatic drugs (DMARDs), and NSAIDs were similar for patients with and without chronic opioid use.

The patients in the study had claims with the specified diagnosis codes during Jan. 1, 2013–March 31, 2016 and were enrolled in medical and pharmacy benefits for 12 months before and after the first qualifying ICD code. The study excluded patients with a history of cancer other than nonmelanoma skin cancer. Opioid claims within 7 days of a hospitalization or 2 days of an emergency department or urgent care visit were not included.

The investigators assessed patients’ demographics, clinical characteristics, comorbidities, and prior treatments during a 12-month baseline period prior to the index date. They examined opioid use and exposure to other treatments during a 12-month follow-up period after the index date. They defined chronic opioid use as at least 90 cumulative days of opioid use based on the supply value on opioid pharmacy claims. They summed the days’ supply for all opioid claims during the follow-up period.

Chronic use of opioids was most pronounced in the 917 patients with Medicaid claims with 720.0 diagnosis codes; 57.1% chronically used opioids during follow-up. Among 14,041 patients with Medicaid claims with 720.x codes, 76.7% chronically used opioids.

The data suggest that some patients may receive opioids before they receive recommended therapies. “If this is the case, there may be an opportunity to prevent chronic opioid use by intervening with recommended therapies earlier in the patient’s treatment course,” the authors wrote.

Dr. Sloan and colleagues noted that they had limited information about the timing of opioid use relative to ankylosing spondylitis diagnosis, opioid potency and dose, and the indication for which opioids were prescribed.

UCB Pharma funded the study. The authors are employees of UCB Pharma.

[email protected]

SOURCE: Sloan VS et al. J Rheumatol. 2019 Jan 15. doi: 10.3899/jrheum.180972.

BIRMINGHAM, ENGLAND – Almost two-thirds of patients with axial spondyloarthritis (axSpA) have more than one medical condition, and these may cluster together, the results of a single-center, cross-sectional study have shown.

Of 419 patients, 61% had multiple conditions, with a median of at least one other condition in addition to axSpA, but some patients had as many as five. The most common other conditions in patients with axSpA were hypertension (19% of patients), depression (16%), and dyspepsia (11%).

In all, 15 clusters of conditions were found, each dominated by one or two conditions in addition to axSpA. The three largest clusters were hypertension and cardiovascular disease (n = 88), anxiety and depression (n = 50), and dyspepsia (n = 31). In the cohort, 69% of the patients were male; the mean age was 45 years.

“Multimorbidity and comorbidity both essentially mean the same thing but from different perspectives,” Sizheng Steven Zhao, MD, said at the annual conference of the British Society for Rheumatology.

“Many of us will be familiar with comorbidity and this is a concept that has one index disease at the center and we consider all other conditions to be coexisting. This is a model you typically see in hospital settings, so you go to see your rheumatologist for your axSpA and your cardiologist for your cardiovascular disease,” he explained.

“From a patient’s perspective, that’s probably a little less helpful to go from specialist to specialist, each only interested in one condition so, quite rightly, there’s been a push towards providing more holistic care with the patient at the center, and this is really encapsulated by the concept of multimorbidity, which is just defined as the coexistence of any two conditions.” The multimorbidity model is particularly suited to a primary care setting rather than a hospital setting, he added.

“Whatever you want to call it, it’s becoming more of a problem,” Dr. Zhao said. There is increasing multimorbidity as people age, and it’s a common problem in those with rheumatic diseases because of shared risk factors, the consequences of systemic inflammation, and how patients are treated.

Prior studies of multimorbidity in axSpA have either been of individual comorbid diseases or counts. Dr. Zhao, a clinical research fellow at Aintree University Hospital in Liverpool, England, and his associates looked at how coexisting conditions might cluster together to provide insight into how these might be better managed collectively in patients with axSpA.


The investigators used an adapted form of the Radner index for determining multimorbidity in patients consecutively seen at the Aintree University Hospital’s rheumatology clinic between 2010 and 2017. The Radner index was adapted to consider 40 chronic conditions, including fibromyalgia and osteoporosis but excluding rheumatic diseases and their extra-articular manifestations.

Dr. Zhao and his colleagues used regression models adjusted for age, gender, symptom duration, smoking status, body mass index, social deprivation, and NSAID use to see what, if any, effect having one of these clusters of multimorbid conditions might have on quality of life, general health, disease activity, and functional impairment measures. Patients with certain clusters of conditions had worse scores, particularly those with coexisting depression and/or anxiety and those with fibromyalgia, irritable bowel syndrome, or both in addition to axSpA.

“These are important conditions to be aware of in the management of axSpA patients,” Dr. Zhao said.

These data are consistent with what has already been published, with between 50% and 60% of patients having other conditions, particularly depression, said consultant rheumatologist Helena Marzo-Ortega, MD, of Leeds Teaching Hospitals NHS Trust, who chaired the session. “These are really important numbers for us to remember in the clinic,” she said.

None of the investigators reported having relevant disclosures.

SOURCE: Zhao S et al., Rheumatology 2019;58(suppl 3), Abstract 035.

BIRMINGHAM, ENGLAND – Almost two-thirds of patients with axial spondyloarthritis (axSpA) have more than one medical condition, and these may cluster together, the results of a single-center, cross-sectional study have shown.

Of 419 patients, 61% had multiple conditions, with a median of at least one other condition in addition to axSpA, but some patients had as many as five. The most common other conditions in patients with axSpA were hypertension (19% of patients), depression (16%), and dyspepsia (11%).

In all, 15 clusters of conditions were found, each dominated by one or two conditions in addition to axSpA. The three largest clusters were hypertension and cardiovascular disease (n = 88), anxiety and depression (n = 50), and dyspepsia (n = 31). In the cohort, 69% of the patients were male; the mean age was 45 years.

“Multimorbidity and comorbidity both essentially mean the same thing but from different perspectives,” Sizheng Steven Zhao, MD, said at the annual conference of the British Society for Rheumatology.

“Many of us will be familiar with comorbidity and this is a concept that has one index disease at the center and we consider all other conditions to be coexisting. This is a model you typically see in hospital settings, so you go to see your rheumatologist for your axSpA and your cardiologist for your cardiovascular disease,” he explained.

“From a patient’s perspective, that’s probably a little less helpful to go from specialist to specialist, each only interested in one condition so, quite rightly, there’s been a push towards providing more holistic care with the patient at the center, and this is really encapsulated by the concept of multimorbidity, which is just defined as the coexistence of any two conditions.” The multimorbidity model is particularly suited to a primary care setting rather than a hospital setting, he added.

“Whatever you want to call it, it’s becoming more of a problem,” Dr. Zhao said. There is increasing multimorbidity as people age, and it’s a common problem in those with rheumatic diseases because of shared risk factors, the consequences of systemic inflammation, and how patients are treated.

Prior studies of multimorbidity in axSpA have either been of individual comorbid diseases or counts. Dr. Zhao, a clinical research fellow at Aintree University Hospital in Liverpool, England, and his associates looked at how coexisting conditions might cluster together to provide insight into how these might be better managed collectively in patients with axSpA.


The investigators used an adapted form of the Radner index for determining multimorbidity in patients consecutively seen at the Aintree University Hospital’s rheumatology clinic between 2010 and 2017. The Radner index was adapted to consider 40 chronic conditions, including fibromyalgia and osteoporosis but excluding rheumatic diseases and their extra-articular manifestations.

Dr. Zhao and his colleagues used regression models adjusted for age, gender, symptom duration, smoking status, body mass index, social deprivation, and NSAID use to see what, if any, effect having one of these clusters of multimorbid conditions might have on quality of life, general health, disease activity, and functional impairment measures. Patients with certain clusters of conditions had worse scores, particularly those with coexisting depression and/or anxiety and those with fibromyalgia, irritable bowel syndrome, or both in addition to axSpA.

“These are important conditions to be aware of in the management of axSpA patients,” Dr. Zhao said.

These data are consistent with what has already been published, with between 50% and 60% of patients having other conditions, particularly depression, said consultant rheumatologist Helena Marzo-Ortega, MD, of Leeds Teaching Hospitals NHS Trust, who chaired the session. “These are really important numbers for us to remember in the clinic,” she said.

None of the investigators reported having relevant disclosures.

SOURCE: Zhao S et al., Rheumatology 2019;58(suppl 3), Abstract 035.

BIRMINGHAM, ENGLAND – Almost two-thirds of patients with axial spondyloarthritis (axSpA) have more than one medical condition, and these may cluster together, the results of a single-center, cross-sectional study have shown.

Of 419 patients, 61% had multiple conditions, with a median of at least one other condition in addition to axSpA, but some patients had as many as five. The most common other conditions in patients with axSpA were hypertension (19% of patients), depression (16%), and dyspepsia (11%).

In all, 15 clusters of conditions were found, each dominated by one or two conditions in addition to axSpA. The three largest clusters were hypertension and cardiovascular disease (n = 88), anxiety and depression (n = 50), and dyspepsia (n = 31). In the cohort, 69% of the patients were male; the mean age was 45 years.

“Multimorbidity and comorbidity both essentially mean the same thing but from different perspectives,” Sizheng Steven Zhao, MD, said at the annual conference of the British Society for Rheumatology.

“Many of us will be familiar with comorbidity and this is a concept that has one index disease at the center and we consider all other conditions to be coexisting. This is a model you typically see in hospital settings, so you go to see your rheumatologist for your axSpA and your cardiologist for your cardiovascular disease,” he explained.

“From a patient’s perspective, that’s probably a little less helpful to go from specialist to specialist, each only interested in one condition so, quite rightly, there’s been a push towards providing more holistic care with the patient at the center, and this is really encapsulated by the concept of multimorbidity, which is just defined as the coexistence of any two conditions.” The multimorbidity model is particularly suited to a primary care setting rather than a hospital setting, he added.

“Whatever you want to call it, it’s becoming more of a problem,” Dr. Zhao said. There is increasing multimorbidity as people age, and it’s a common problem in those with rheumatic diseases because of shared risk factors, the consequences of systemic inflammation, and how patients are treated.

Prior studies of multimorbidity in axSpA have either been of individual comorbid diseases or counts. Dr. Zhao, a clinical research fellow at Aintree University Hospital in Liverpool, England, and his associates looked at how coexisting conditions might cluster together to provide insight into how these might be better managed collectively in patients with axSpA.


The investigators used an adapted form of the Radner index for determining multimorbidity in patients consecutively seen at the Aintree University Hospital’s rheumatology clinic between 2010 and 2017. The Radner index was adapted to consider 40 chronic conditions, including fibromyalgia and osteoporosis but excluding rheumatic diseases and their extra-articular manifestations.

Dr. Zhao and his colleagues used regression models adjusted for age, gender, symptom duration, smoking status, body mass index, social deprivation, and NSAID use to see what, if any, effect having one of these clusters of multimorbid conditions might have on quality of life, general health, disease activity, and functional impairment measures. Patients with certain clusters of conditions had worse scores, particularly those with coexisting depression and/or anxiety and those with fibromyalgia, irritable bowel syndrome, or both in addition to axSpA.

“These are important conditions to be aware of in the management of axSpA patients,” Dr. Zhao said.

These data are consistent with what has already been published, with between 50% and 60% of patients having other conditions, particularly depression, said consultant rheumatologist Helena Marzo-Ortega, MD, of Leeds Teaching Hospitals NHS Trust, who chaired the session. “These are really important numbers for us to remember in the clinic,” she said.

None of the investigators reported having relevant disclosures.

SOURCE: Zhao S et al., Rheumatology 2019;58(suppl 3), Abstract 035.

MADISON, WISC. – Low-dose CT may one day represent an accessible, affordable, and safe imaging option to aid in diagnosis and management of spondyloarthritis, but it’s not quite ready for everyday use, said Robert Lambert, MD, speaking at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

“Low-dose CT of the SI [sacroiliac] joints is probably underutilized,” said Dr. Lambert, chair of the department of radiology and diagnostic imaging at the University of Alberta, Edmonton. “Subtle bony changes are demonstrated very well, and it can be an excellent test for resolving equivocal findings on x-ray or MRI.”

An important first step in making imaging decisions is to put concerns about radiation exposure in context, said Dr. Lambert. “Today, almost all CT effective exposure doses are considered low risk.”

Older studies have shown that a conventional two-view chest radiograph delivers a dose of 0.1 mSv – the equivalent of 10 days of background radiation – whereas the highest radiation dose is delivered by a CT scan of the abdomen and pelvis with and without contrast. This examination delivers an effective dose of 20 mSv, the equivalent of 7 years of background radiation. Dr. Lambert pointed out what the “moderate” additional lifetime risk of malignancy – 1:500 – associated with this scan looks like in real-world numbers: “So the lifetime risk of cancer would increase from 20% to 20.2%.”

Recently, measurements of effective doses delivered in low-dose CT (ldCT) have shown that “most doses are significantly lower than previously quoted,” said Dr. Lambert. For example, ldCT of the SI joints delivers just 0.42 mSv, a radiation dose that’s in the same minimal risk category as a chest radiograph. In fact, for patients with high body mass, the radiation dose from ldCT of the SI joints can be less than that from a conventional radiograph.

“Could low-dose CT of the spine better detect new bone formation, compared to x-ray?” Dr. Lambert asked. A recent study attempted to answer the question, looking at 40 patients with ankylosing spondylitis who received ldCT at baseline and 2 years later (Ann Rheum Dis. 2018;77:371-7). In developing a CT syndesmophyte score (CTSS), two independent readers, blinded to the time order in which images were obtained, assessed vertebral syndesmophytes in the coronal and sagittal planes for each patient. The conclusion was that “new bone formation in the spine of patients with ankylosing spondylitis can be assessed reliably,” Dr. Lambert said.

A related study directly compared the new CTSS system with the modified Stoke Ankylosing Spondylitis Spine Score, used for conventional radiographs. Both studies used data from the Sensitive Imaging in Ankylosing Spondylitis cohort.

In this latter study, whole spine ldCT tracked progression better than conventional radiographs because it detected more new and growing syndesmophytes, Dr. Lambert said. One important reason for this was that conventional radiography only has utility in the cervical and lumbar spine and the pelvis, while most progression was seen in the thoracic spine with ldCT (Ann Rheum Dis. 2018;77:293-9).

The radiation dose for ldCT of the spine – approximately 4 mSv – is about 10 times that for ldCT of the SI joints, but still one-half to three-quarters of the dose for a whole-spine CT, Dr. Lambert said. Put another way, the ldCT whole-spine dose is nearly equivalent to the dose for the three radiographic studies required to image the cervical, thoracic, and lumbar spine.

Another imaging approach using CT zooms in on the thoracolumbar spine, imaging vertebrae T10-L4. Through sophisticated computational reconstruction techniques, the researchers were able to quantify syndesmophyte height circumferentially around each vertebra (J Rheumatol. 2015;42[3]:472-8).

The study, which imaged 33 patients at baseline and then at year 1 and year 2, found that the circumferential syndesmophyte height correlated well with spinal flexibility. Variation was low between two scans performed on the same day, at 0.893% per patient. Despite these advantages of high reliability and good sensitivity to change, one consideration for clinical consideration is the radiation dose, estimated about 8 mSv, Dr. Lambert noted.

Though MRI is a keystone for diagnosis and management of spondyloarthritis, Dr. Lambert pointed out that it’s more expensive than CT and still not routinely available everywhere. He also noted that reimbursement and prior authorizations may be easier to obtain for CT.

“Low-dose CT has tremendous research potential, especially in the thoracic spine,” said Dr. Lambert. “But it’s not ready for routine clinical use. First, the dose is not trivial, at about 4 mSv.” Also, it’s time consuming to interpret and not all CT scanners are compatible with ldCT techniques. “Lower dose can mean lower imaging quality,” and syndesmophytes can be harder to detect in larger individuals.

Dr. Lambert reported no relevant conflicts of interest.

[email protected]

MADISON, WISC. – Low-dose CT may one day represent an accessible, affordable, and safe imaging option to aid in diagnosis and management of spondyloarthritis, but it’s not quite ready for everyday use, said Robert Lambert, MD, speaking at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

“Low-dose CT of the SI [sacroiliac] joints is probably underutilized,” said Dr. Lambert, chair of the department of radiology and diagnostic imaging at the University of Alberta, Edmonton. “Subtle bony changes are demonstrated very well, and it can be an excellent test for resolving equivocal findings on x-ray or MRI.”

An important first step in making imaging decisions is to put concerns about radiation exposure in context, said Dr. Lambert. “Today, almost all CT effective exposure doses are considered low risk.”

Older studies have shown that a conventional two-view chest radiograph delivers a dose of 0.1 mSv – the equivalent of 10 days of background radiation – whereas the highest radiation dose is delivered by a CT scan of the abdomen and pelvis with and without contrast. This examination delivers an effective dose of 20 mSv, the equivalent of 7 years of background radiation. Dr. Lambert pointed out what the “moderate” additional lifetime risk of malignancy – 1:500 – associated with this scan looks like in real-world numbers: “So the lifetime risk of cancer would increase from 20% to 20.2%.”

Recently, measurements of effective doses delivered in low-dose CT (ldCT) have shown that “most doses are significantly lower than previously quoted,” said Dr. Lambert. For example, ldCT of the SI joints delivers just 0.42 mSv, a radiation dose that’s in the same minimal risk category as a chest radiograph. In fact, for patients with high body mass, the radiation dose from ldCT of the SI joints can be less than that from a conventional radiograph.

“Could low-dose CT of the spine better detect new bone formation, compared to x-ray?” Dr. Lambert asked. A recent study attempted to answer the question, looking at 40 patients with ankylosing spondylitis who received ldCT at baseline and 2 years later (Ann Rheum Dis. 2018;77:371-7). In developing a CT syndesmophyte score (CTSS), two independent readers, blinded to the time order in which images were obtained, assessed vertebral syndesmophytes in the coronal and sagittal planes for each patient. The conclusion was that “new bone formation in the spine of patients with ankylosing spondylitis can be assessed reliably,” Dr. Lambert said.

A related study directly compared the new CTSS system with the modified Stoke Ankylosing Spondylitis Spine Score, used for conventional radiographs. Both studies used data from the Sensitive Imaging in Ankylosing Spondylitis cohort.

In this latter study, whole spine ldCT tracked progression better than conventional radiographs because it detected more new and growing syndesmophytes, Dr. Lambert said. One important reason for this was that conventional radiography only has utility in the cervical and lumbar spine and the pelvis, while most progression was seen in the thoracic spine with ldCT (Ann Rheum Dis. 2018;77:293-9).

The radiation dose for ldCT of the spine – approximately 4 mSv – is about 10 times that for ldCT of the SI joints, but still one-half to three-quarters of the dose for a whole-spine CT, Dr. Lambert said. Put another way, the ldCT whole-spine dose is nearly equivalent to the dose for the three radiographic studies required to image the cervical, thoracic, and lumbar spine.

Another imaging approach using CT zooms in on the thoracolumbar spine, imaging vertebrae T10-L4. Through sophisticated computational reconstruction techniques, the researchers were able to quantify syndesmophyte height circumferentially around each vertebra (J Rheumatol. 2015;42[3]:472-8).

The study, which imaged 33 patients at baseline and then at year 1 and year 2, found that the circumferential syndesmophyte height correlated well with spinal flexibility. Variation was low between two scans performed on the same day, at 0.893% per patient. Despite these advantages of high reliability and good sensitivity to change, one consideration for clinical consideration is the radiation dose, estimated about 8 mSv, Dr. Lambert noted.

Though MRI is a keystone for diagnosis and management of spondyloarthritis, Dr. Lambert pointed out that it’s more expensive than CT and still not routinely available everywhere. He also noted that reimbursement and prior authorizations may be easier to obtain for CT.

“Low-dose CT has tremendous research potential, especially in the thoracic spine,” said Dr. Lambert. “But it’s not ready for routine clinical use. First, the dose is not trivial, at about 4 mSv.” Also, it’s time consuming to interpret and not all CT scanners are compatible with ldCT techniques. “Lower dose can mean lower imaging quality,” and syndesmophytes can be harder to detect in larger individuals.

Dr. Lambert reported no relevant conflicts of interest.

[email protected]

MADISON, WISC. – Low-dose CT may one day represent an accessible, affordable, and safe imaging option to aid in diagnosis and management of spondyloarthritis, but it’s not quite ready for everyday use, said Robert Lambert, MD, speaking at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

“Low-dose CT of the SI [sacroiliac] joints is probably underutilized,” said Dr. Lambert, chair of the department of radiology and diagnostic imaging at the University of Alberta, Edmonton. “Subtle bony changes are demonstrated very well, and it can be an excellent test for resolving equivocal findings on x-ray or MRI.”

An important first step in making imaging decisions is to put concerns about radiation exposure in context, said Dr. Lambert. “Today, almost all CT effective exposure doses are considered low risk.”

Older studies have shown that a conventional two-view chest radiograph delivers a dose of 0.1 mSv – the equivalent of 10 days of background radiation – whereas the highest radiation dose is delivered by a CT scan of the abdomen and pelvis with and without contrast. This examination delivers an effective dose of 20 mSv, the equivalent of 7 years of background radiation. Dr. Lambert pointed out what the “moderate” additional lifetime risk of malignancy – 1:500 – associated with this scan looks like in real-world numbers: “So the lifetime risk of cancer would increase from 20% to 20.2%.”

Recently, measurements of effective doses delivered in low-dose CT (ldCT) have shown that “most doses are significantly lower than previously quoted,” said Dr. Lambert. For example, ldCT of the SI joints delivers just 0.42 mSv, a radiation dose that’s in the same minimal risk category as a chest radiograph. In fact, for patients with high body mass, the radiation dose from ldCT of the SI joints can be less than that from a conventional radiograph.

“Could low-dose CT of the spine better detect new bone formation, compared to x-ray?” Dr. Lambert asked. A recent study attempted to answer the question, looking at 40 patients with ankylosing spondylitis who received ldCT at baseline and 2 years later (Ann Rheum Dis. 2018;77:371-7). In developing a CT syndesmophyte score (CTSS), two independent readers, blinded to the time order in which images were obtained, assessed vertebral syndesmophytes in the coronal and sagittal planes for each patient. The conclusion was that “new bone formation in the spine of patients with ankylosing spondylitis can be assessed reliably,” Dr. Lambert said.

A related study directly compared the new CTSS system with the modified Stoke Ankylosing Spondylitis Spine Score, used for conventional radiographs. Both studies used data from the Sensitive Imaging in Ankylosing Spondylitis cohort.

In this latter study, whole spine ldCT tracked progression better than conventional radiographs because it detected more new and growing syndesmophytes, Dr. Lambert said. One important reason for this was that conventional radiography only has utility in the cervical and lumbar spine and the pelvis, while most progression was seen in the thoracic spine with ldCT (Ann Rheum Dis. 2018;77:293-9).

The radiation dose for ldCT of the spine – approximately 4 mSv – is about 10 times that for ldCT of the SI joints, but still one-half to three-quarters of the dose for a whole-spine CT, Dr. Lambert said. Put another way, the ldCT whole-spine dose is nearly equivalent to the dose for the three radiographic studies required to image the cervical, thoracic, and lumbar spine.

Another imaging approach using CT zooms in on the thoracolumbar spine, imaging vertebrae T10-L4. Through sophisticated computational reconstruction techniques, the researchers were able to quantify syndesmophyte height circumferentially around each vertebra (J Rheumatol. 2015;42[3]:472-8).

The study, which imaged 33 patients at baseline and then at year 1 and year 2, found that the circumferential syndesmophyte height correlated well with spinal flexibility. Variation was low between two scans performed on the same day, at 0.893% per patient. Despite these advantages of high reliability and good sensitivity to change, one consideration for clinical consideration is the radiation dose, estimated about 8 mSv, Dr. Lambert noted.

Though MRI is a keystone for diagnosis and management of spondyloarthritis, Dr. Lambert pointed out that it’s more expensive than CT and still not routinely available everywhere. He also noted that reimbursement and prior authorizations may be easier to obtain for CT.

“Low-dose CT has tremendous research potential, especially in the thoracic spine,” said Dr. Lambert. “But it’s not ready for routine clinical use. First, the dose is not trivial, at about 4 mSv.” Also, it’s time consuming to interpret and not all CT scanners are compatible with ldCT techniques. “Lower dose can mean lower imaging quality,” and syndesmophytes can be harder to detect in larger individuals.

Dr. Lambert reported no relevant conflicts of interest.

[email protected]