Rheumatoid Arthritis

BERLIN – Patients with at least three erosive joints in their hands and feet have rheumatoid arthritis regardless of whatever other signs and symptoms they may or may not have, according to a task force of the American College of Rheumatology and the European League Against Rheumatism (Ann. Rheum. Dis. 2012;71[Suppl3]:25).

This unanimous decision from the 18-member international task force closes the circle for redefining the classification of rheumatoid arthritis patients, a process that began with the 2010 release of a new signs and symptoms–driven rheumatoid arthritis (RA) classification that had no role for radiographic evidence of joint erosions (Arthritis Rheum. 2010;62:2569-81).

Although "radiographs are not required in the ACR/EULAR classification criteria, the presence of typical erosions allows classification of RA even without fulfillment of the [2010] scoring system," task force leader Dr. Désirée van der Heijde said at the meeting. "Radiographs should be taken in an unclassified patient in whom long-standing, inactive disease is suspected, and is likely misclassified," said Dr. van der Heijde, professor rheumatology at Leiden (the Netherlands) University Medical Center. Another common scenario is when a radiograph already exists for a patient who might have early arthritis because it was taken before rheumatologic referral.

The key premise of the new erosive-joint classification was that because radiographs alone could classify a patient as having RA, the erosive joint criteria had to be very specific and produce a minimal number of false positives. Lack of sensitivity was not an issue, as patients could also be classified with RA by the 2010 criteria.

To get a sense of how many erosive joints are needed to produce a reliable identification of RA, the task force studied data collected from two early-arthritis groups, the Early Arthritis Cohort assembled in Leiden with 902 patients, and the Etude et Suivi des Polyarthrites Indifferenciées Récentes (ESPOIR) cohort assembled in Montpellier, France with 811 patients. The task force focused on the subgroup of people in either cohort who did not meet the 2010 classification criteria for RA, and examined the link between various numbers of erosive joints in these people and the incidence of three outcomes the task force considered pathognomonic for RA: on methotrexate treatment after 1 year, on treatment with any disease-modifying antirheumatic drug after 1 year, or disease persistence for 5 years. They found that all three outcomes occurred at similar rates.

In the ESPOIR cohort, with the end point of 5-year disease persistence, people with at least three erosive joints developed RA with a specificity of 91% and a sensitivity of 24%. (An erosive joint was any hand or foot joint with at least one radiographic erosion visible as a cortical break.) In contrast, a threshold of at least two erosive joints carried a specificity of 82% – putting it below the 90% the task force sought – and a sensitivity of 30%. In the Leiden cohort, three or more erosive joints had a sensitivity of 95% and a sensitivity of 15%, while two or more joints was 91% specific and 20% sensitive.

"Some rheumatologists might be surprised [at the need for three erosive joints] because they think that just one erosion is very specific for RA. We showed that one erosion is not specific; you really need more to be very specific for RA," she said in an interview. "After we saw the data it was very clear to us that three would be the right cutoff. It was a unanimous decision."

It also turned out that a criterion of three or more erosive joints kept a lid on the number of positive classifications. In the Leiden cohort, 31 (10%) of the 308 enrollees who did not meet the 2010 clinical criteria met the radiographic threshold; in the ESPOIR cohort, 18 (12%) of 147 had at least three erosive joints.

"There will not be many patients who get classified," based on their erosive joints, she noted. Despite that, "it’s very important to have this definition, because many people were asking for it. It’s important to have a clear definition. And it’s important for patients who do not meet the classification criteria but have several erosions."

"Erosions are the hallmark of RA; if patients have erosions they don’t need anything else," commented Dr. Alan Silman, medical director of Arthritis Research UK in Chesterfield, England. The new findings show "there are very few people with RA who just have erosions. The results support the classification criteria," by showing that the 2010 criteria capture roughly 90% of all RA patients, he said in an interview.

Dr. van der Heijde and Dr. Silman said that they had no disclosures.

BERLIN – Patients with at least three erosive joints in their hands and feet have rheumatoid arthritis regardless of whatever other signs and symptoms they may or may not have, according to a task force of the American College of Rheumatology and the European League Against Rheumatism (Ann. Rheum. Dis. 2012;71[Suppl3]:25).

This unanimous decision from the 18-member international task force closes the circle for redefining the classification of rheumatoid arthritis patients, a process that began with the 2010 release of a new signs and symptoms–driven rheumatoid arthritis (RA) classification that had no role for radiographic evidence of joint erosions (Arthritis Rheum. 2010;62:2569-81).

Although "radiographs are not required in the ACR/EULAR classification criteria, the presence of typical erosions allows classification of RA even without fulfillment of the [2010] scoring system," task force leader Dr. Désirée van der Heijde said at the meeting. "Radiographs should be taken in an unclassified patient in whom long-standing, inactive disease is suspected, and is likely misclassified," said Dr. van der Heijde, professor rheumatology at Leiden (the Netherlands) University Medical Center. Another common scenario is when a radiograph already exists for a patient who might have early arthritis because it was taken before rheumatologic referral.

The key premise of the new erosive-joint classification was that because radiographs alone could classify a patient as having RA, the erosive joint criteria had to be very specific and produce a minimal number of false positives. Lack of sensitivity was not an issue, as patients could also be classified with RA by the 2010 criteria.

To get a sense of how many erosive joints are needed to produce a reliable identification of RA, the task force studied data collected from two early-arthritis groups, the Early Arthritis Cohort assembled in Leiden with 902 patients, and the Etude et Suivi des Polyarthrites Indifferenciées Récentes (ESPOIR) cohort assembled in Montpellier, France with 811 patients. The task force focused on the subgroup of people in either cohort who did not meet the 2010 classification criteria for RA, and examined the link between various numbers of erosive joints in these people and the incidence of three outcomes the task force considered pathognomonic for RA: on methotrexate treatment after 1 year, on treatment with any disease-modifying antirheumatic drug after 1 year, or disease persistence for 5 years. They found that all three outcomes occurred at similar rates.

In the ESPOIR cohort, with the end point of 5-year disease persistence, people with at least three erosive joints developed RA with a specificity of 91% and a sensitivity of 24%. (An erosive joint was any hand or foot joint with at least one radiographic erosion visible as a cortical break.) In contrast, a threshold of at least two erosive joints carried a specificity of 82% – putting it below the 90% the task force sought – and a sensitivity of 30%. In the Leiden cohort, three or more erosive joints had a sensitivity of 95% and a sensitivity of 15%, while two or more joints was 91% specific and 20% sensitive.

"Some rheumatologists might be surprised [at the need for three erosive joints] because they think that just one erosion is very specific for RA. We showed that one erosion is not specific; you really need more to be very specific for RA," she said in an interview. "After we saw the data it was very clear to us that three would be the right cutoff. It was a unanimous decision."

It also turned out that a criterion of three or more erosive joints kept a lid on the number of positive classifications. In the Leiden cohort, 31 (10%) of the 308 enrollees who did not meet the 2010 clinical criteria met the radiographic threshold; in the ESPOIR cohort, 18 (12%) of 147 had at least three erosive joints.

"There will not be many patients who get classified," based on their erosive joints, she noted. Despite that, "it’s very important to have this definition, because many people were asking for it. It’s important to have a clear definition. And it’s important for patients who do not meet the classification criteria but have several erosions."

"Erosions are the hallmark of RA; if patients have erosions they don’t need anything else," commented Dr. Alan Silman, medical director of Arthritis Research UK in Chesterfield, England. The new findings show "there are very few people with RA who just have erosions. The results support the classification criteria," by showing that the 2010 criteria capture roughly 90% of all RA patients, he said in an interview.

Dr. van der Heijde and Dr. Silman said that they had no disclosures.

BERLIN – Patients with at least three erosive joints in their hands and feet have rheumatoid arthritis regardless of whatever other signs and symptoms they may or may not have, according to a task force of the American College of Rheumatology and the European League Against Rheumatism (Ann. Rheum. Dis. 2012;71[Suppl3]:25).

This unanimous decision from the 18-member international task force closes the circle for redefining the classification of rheumatoid arthritis patients, a process that began with the 2010 release of a new signs and symptoms–driven rheumatoid arthritis (RA) classification that had no role for radiographic evidence of joint erosions (Arthritis Rheum. 2010;62:2569-81).

Although "radiographs are not required in the ACR/EULAR classification criteria, the presence of typical erosions allows classification of RA even without fulfillment of the [2010] scoring system," task force leader Dr. Désirée van der Heijde said at the meeting. "Radiographs should be taken in an unclassified patient in whom long-standing, inactive disease is suspected, and is likely misclassified," said Dr. van der Heijde, professor rheumatology at Leiden (the Netherlands) University Medical Center. Another common scenario is when a radiograph already exists for a patient who might have early arthritis because it was taken before rheumatologic referral.

The key premise of the new erosive-joint classification was that because radiographs alone could classify a patient as having RA, the erosive joint criteria had to be very specific and produce a minimal number of false positives. Lack of sensitivity was not an issue, as patients could also be classified with RA by the 2010 criteria.

To get a sense of how many erosive joints are needed to produce a reliable identification of RA, the task force studied data collected from two early-arthritis groups, the Early Arthritis Cohort assembled in Leiden with 902 patients, and the Etude et Suivi des Polyarthrites Indifferenciées Récentes (ESPOIR) cohort assembled in Montpellier, France with 811 patients. The task force focused on the subgroup of people in either cohort who did not meet the 2010 classification criteria for RA, and examined the link between various numbers of erosive joints in these people and the incidence of three outcomes the task force considered pathognomonic for RA: on methotrexate treatment after 1 year, on treatment with any disease-modifying antirheumatic drug after 1 year, or disease persistence for 5 years. They found that all three outcomes occurred at similar rates.

In the ESPOIR cohort, with the end point of 5-year disease persistence, people with at least three erosive joints developed RA with a specificity of 91% and a sensitivity of 24%. (An erosive joint was any hand or foot joint with at least one radiographic erosion visible as a cortical break.) In contrast, a threshold of at least two erosive joints carried a specificity of 82% – putting it below the 90% the task force sought – and a sensitivity of 30%. In the Leiden cohort, three or more erosive joints had a sensitivity of 95% and a sensitivity of 15%, while two or more joints was 91% specific and 20% sensitive.

"Some rheumatologists might be surprised [at the need for three erosive joints] because they think that just one erosion is very specific for RA. We showed that one erosion is not specific; you really need more to be very specific for RA," she said in an interview. "After we saw the data it was very clear to us that three would be the right cutoff. It was a unanimous decision."

It also turned out that a criterion of three or more erosive joints kept a lid on the number of positive classifications. In the Leiden cohort, 31 (10%) of the 308 enrollees who did not meet the 2010 clinical criteria met the radiographic threshold; in the ESPOIR cohort, 18 (12%) of 147 had at least three erosive joints.

"There will not be many patients who get classified," based on their erosive joints, she noted. Despite that, "it’s very important to have this definition, because many people were asking for it. It’s important to have a clear definition. And it’s important for patients who do not meet the classification criteria but have several erosions."

"Erosions are the hallmark of RA; if patients have erosions they don’t need anything else," commented Dr. Alan Silman, medical director of Arthritis Research UK in Chesterfield, England. The new findings show "there are very few people with RA who just have erosions. The results support the classification criteria," by showing that the 2010 criteria capture roughly 90% of all RA patients, he said in an interview.

Dr. van der Heijde and Dr. Silman said that they had no disclosures.

BERLIN – Occupational exposures associated with increased risk of rheumatoid arthritis include jobs involving inhalation of chemicals or dusts as well as work in cold or humid conditions, according to data from a new Scandinavian case-control study.

Dr. Ritta-Sisko Koskela obtained detailed occupational exposure histories from more than 2,000 employed Finnish adults with rheumatoid arthritis (RA) and an equal number of hypertensive controls matched for age, occupation, gender, and region.

The impetus for the study was her observation that the age-adjusted prevalence of RA in Finland shows considerable geographic variation. Some of the highest rates occur in areas where certain industries are concentrated, such as mining, steel manufacturing, chemical processing, and ship dockyards, explained Dr. Koskela of the Finnish Institute of Occupational Health, Helsinki.

A prominent theme that emerged from the data is that occupationally linked RA seems to require a long duration of exposure and entails a lengthy latency period. For example, dock and warehouse workers with RA were 3.1-fold more likely to work under drafty conditions than were hypertensive dock workers without RA. The individuals with RA had a mean 15 years of exposure to drafty conditions, and they developed the disease an average of 20 years after this workplace exposure began.

And those were among the shortest exposure and latency times recorded in the entire study. For instance, chemical plant workers with RA were 6.9-fold more likely to have been working under cold conditions than were their coworkers without RA; they averaged a 26-year exposure history and a 29-year latency period. And metal workers with RA were 10.4-fold more likely to work with rubber and elastomers than were metal workers without RA; the workers with RA had an 18-year history of exposure to those chemicals and a 23-year latency phase, she said at the annual European Congress of Rheumatology.

Truckers with RA were 5.7- to 8.3-fold more likely to haul grain, concrete, or gas mixtures than were truckers without RA. And textile workers with RA were 8.7 times more likely to labor under humid conditions than were those without the disease. Farmers and foresters with RA were 2.1-fold more likely to work under high-humidity conditions and 6.1-fold more likely to experience infection by parasites or insect vectors than were those without RA.

Inhaled dusts linked to an increased prevalence of RA included synthetic mineral fibers, concrete, paints, pesticides, and carbonate minerals.

Dr. Koskela’s study builds on an earlier Swedish analysis of a national database including nearly 30,000 Swedes hospitalized for RA. That study identified certain occupations as being associated with increased risk, among them mining, farming, and electrical work, and in women nursing and social work (J. Rheumatol. 2008;35:986-91). The Finnish study takes things a step further by examining specific work-related factors within higher-risk occupations that distinguish those who develop RA from those who don’t. The aim is eventually to reduce the incidence of RA through avoidance of potentially modifiable exposures.

Dr. Koskela reported having no financial conflicts.

BERLIN – Occupational exposures associated with increased risk of rheumatoid arthritis include jobs involving inhalation of chemicals or dusts as well as work in cold or humid conditions, according to data from a new Scandinavian case-control study.

Dr. Ritta-Sisko Koskela obtained detailed occupational exposure histories from more than 2,000 employed Finnish adults with rheumatoid arthritis (RA) and an equal number of hypertensive controls matched for age, occupation, gender, and region.

The impetus for the study was her observation that the age-adjusted prevalence of RA in Finland shows considerable geographic variation. Some of the highest rates occur in areas where certain industries are concentrated, such as mining, steel manufacturing, chemical processing, and ship dockyards, explained Dr. Koskela of the Finnish Institute of Occupational Health, Helsinki.

A prominent theme that emerged from the data is that occupationally linked RA seems to require a long duration of exposure and entails a lengthy latency period. For example, dock and warehouse workers with RA were 3.1-fold more likely to work under drafty conditions than were hypertensive dock workers without RA. The individuals with RA had a mean 15 years of exposure to drafty conditions, and they developed the disease an average of 20 years after this workplace exposure began.

And those were among the shortest exposure and latency times recorded in the entire study. For instance, chemical plant workers with RA were 6.9-fold more likely to have been working under cold conditions than were their coworkers without RA; they averaged a 26-year exposure history and a 29-year latency period. And metal workers with RA were 10.4-fold more likely to work with rubber and elastomers than were metal workers without RA; the workers with RA had an 18-year history of exposure to those chemicals and a 23-year latency phase, she said at the annual European Congress of Rheumatology.

Truckers with RA were 5.7- to 8.3-fold more likely to haul grain, concrete, or gas mixtures than were truckers without RA. And textile workers with RA were 8.7 times more likely to labor under humid conditions than were those without the disease. Farmers and foresters with RA were 2.1-fold more likely to work under high-humidity conditions and 6.1-fold more likely to experience infection by parasites or insect vectors than were those without RA.

Inhaled dusts linked to an increased prevalence of RA included synthetic mineral fibers, concrete, paints, pesticides, and carbonate minerals.

Dr. Koskela’s study builds on an earlier Swedish analysis of a national database including nearly 30,000 Swedes hospitalized for RA. That study identified certain occupations as being associated with increased risk, among them mining, farming, and electrical work, and in women nursing and social work (J. Rheumatol. 2008;35:986-91). The Finnish study takes things a step further by examining specific work-related factors within higher-risk occupations that distinguish those who develop RA from those who don’t. The aim is eventually to reduce the incidence of RA through avoidance of potentially modifiable exposures.

Dr. Koskela reported having no financial conflicts.

BERLIN – Occupational exposures associated with increased risk of rheumatoid arthritis include jobs involving inhalation of chemicals or dusts as well as work in cold or humid conditions, according to data from a new Scandinavian case-control study.

Dr. Ritta-Sisko Koskela obtained detailed occupational exposure histories from more than 2,000 employed Finnish adults with rheumatoid arthritis (RA) and an equal number of hypertensive controls matched for age, occupation, gender, and region.

The impetus for the study was her observation that the age-adjusted prevalence of RA in Finland shows considerable geographic variation. Some of the highest rates occur in areas where certain industries are concentrated, such as mining, steel manufacturing, chemical processing, and ship dockyards, explained Dr. Koskela of the Finnish Institute of Occupational Health, Helsinki.

A prominent theme that emerged from the data is that occupationally linked RA seems to require a long duration of exposure and entails a lengthy latency period. For example, dock and warehouse workers with RA were 3.1-fold more likely to work under drafty conditions than were hypertensive dock workers without RA. The individuals with RA had a mean 15 years of exposure to drafty conditions, and they developed the disease an average of 20 years after this workplace exposure began.

And those were among the shortest exposure and latency times recorded in the entire study. For instance, chemical plant workers with RA were 6.9-fold more likely to have been working under cold conditions than were their coworkers without RA; they averaged a 26-year exposure history and a 29-year latency period. And metal workers with RA were 10.4-fold more likely to work with rubber and elastomers than were metal workers without RA; the workers with RA had an 18-year history of exposure to those chemicals and a 23-year latency phase, she said at the annual European Congress of Rheumatology.

Truckers with RA were 5.7- to 8.3-fold more likely to haul grain, concrete, or gas mixtures than were truckers without RA. And textile workers with RA were 8.7 times more likely to labor under humid conditions than were those without the disease. Farmers and foresters with RA were 2.1-fold more likely to work under high-humidity conditions and 6.1-fold more likely to experience infection by parasites or insect vectors than were those without RA.

Inhaled dusts linked to an increased prevalence of RA included synthetic mineral fibers, concrete, paints, pesticides, and carbonate minerals.

Dr. Koskela’s study builds on an earlier Swedish analysis of a national database including nearly 30,000 Swedes hospitalized for RA. That study identified certain occupations as being associated with increased risk, among them mining, farming, and electrical work, and in women nursing and social work (J. Rheumatol. 2008;35:986-91). The Finnish study takes things a step further by examining specific work-related factors within higher-risk occupations that distinguish those who develop RA from those who don’t. The aim is eventually to reduce the incidence of RA through avoidance of potentially modifiable exposures.

Dr. Koskela reported having no financial conflicts.

BERLIN – The tumor necrosis factor inhibitor certolizumab pegol significantly lessened both joint and skin symptoms of psoriatic arthritis in a pivotal phase-III clinical trial.

"This will be the basis for seeking regulatory approval for this drug in the treatment of psoriatic arthritis. It’s a very important development because we don’t have quite the armamentarium of drugs for treating psoriatic arthritis that we do in treating rheumatoid arthritis," Dr. Philip J. Mease observed when he presented the results of the study, known as RAPID-PsA, at the annual European Congress of Rheumatology.

The ACR 20, ACR 50, and ACR 70 responses (that is, 20%, 50%, and 70% improvements, respectively, in certain parameters specified by the American College of Rheumatology) to certolizumab were two- to fourfold higher than in placebo-treated controls. Also impressive were the proportion of certolizumab-treated patients with at least a PASI 75 (that is, a 75% improvement in the Psoriasis Area and Severity Index), as well as the documented improvement in physical functioning. But perhaps most striking of all was the kinetics of the response to certolizumab.

"As early as 1 week with this agent, it separates from placebo. There’s a very fast onset of action with certolizumab," noted Dr. Mease of the University of Washington, Seattle.

The 24-week, three-armed, phase III, double-blind clinical trial included 409 psoriatic arthritis (PsA) patients. They were randomized to placebo or to a loading dose of 400 mg of subcutaneous certolizumab (Cimzia) at weeks 0, 2, and 4, then were further randomized to continue certolizumab at either 200 mg every 2 weeks or 400 mg every 4 weeks.

These patients had severe PsA, with a mean baseline of 20 tender and 11 swollen joints. Nearly two-thirds of subjects had enthesitis and one-third had dactylitis. Their median baseline PASI was in the 7-8 range, with C-reactive protein levels ranging from 7 mg/L to 9 mg/L. All subjects had failed at least one disease-modifying antirheumatic drug, and about half had failed two or more. Moreover, 20% of subjects had previously received a TNF inhibitor that over time had become ineffective.

"That makes it presumably tougher to achieve the kinds of responses we see in most other trials where patients are required to be naive to anti-TNF medications. But this design more approximates a real-world situation in which some of the patients you’re treating receive certolizumab as first-line therapy, but others may receive it as second- or third-line anti-TNF medication," the rheumatologist explained.

The ACR 20 response to the pegylated humanized TNF inhibitor at week 12 (the prespecified primary study end point) was closely similar in the twice-monthly and once-monthly dosing groups, as was the ACR 50 response. However, the twice-monthly 200-mg regimen was superior at achieving ACR 70. (See box.)

Skin responses were "quite robust," Dr. Mease declared. At week 12, among patients with at least 3% body surface area involvement at baseline, PASI 75 responses were documented in 47% of patients in either of the certolizumab arms, compared with 14% of placebo-treated controls. At week 24, PASI 75 responses were noted in 62% of patients on twice-monthly certolizumab, in 61% of those on once-monthly therapy, and in 15% of controls.

Improved physical functioning was reflected in a mean 0.54-point reduction at week 24 from a mean baseline HAQ-DI (Health Assessment Questionnaire-Disease Index) score of 1.3 in the twice-monthly certolizumab group and a 0.46-point decrease with once-monthly therapy, both of which were well beyond the 0.35-point reduction threshold conventionally deemed to be a minimally clinically important improvement. In contrast, HAQ-DI scores decreased by a mean of only 0.19 points in the control group.

Side effects were the same as those seen in the treatment of rheumatoid arthritis, for which certolizumab is approved in the United States and Europe with the same dosing choices.

"No new safety news," Dr. Mease commented.

He noted that he was presenting a first look at the RAPID-PsA results. Later this year at the annual meeting of the American College of Rheumatology, he and his coinvestigators will be able to share the results of ongoing analyses of the radiographic response to treatment, as well as certolizumab’s ability to treat enthesitis and dactylitis.

Dr. Mease predicted that the dosing that’s ultimately approved for PsA will mimic that used in RA, offering patients the flexibility to choose between once- and twice-monthly therapy.

Psoriasis occurs in about 2.1% of the general population worldwide. Roughly 30% of affected patients also have PsA.

"This is one of the most devastating diseases a person can have because not only does it feature the functional impairment of a musculoskeletal disease but also the embarrassing cosmetic problems of psoriasis. Psoriatic arthritis is one of the few diseases we work with in rheumatology where suicide is one of the reasons for increased early mortality," Dr. Mease said.

Dr. Mease reported financial relation ships with UCB, which markets certolizumab. In addition, as a clinical trialist he has financial relationships with numerous other pharmaceutical companies that are interested in rheumatologic diseases.

BERLIN – The tumor necrosis factor inhibitor certolizumab pegol significantly lessened both joint and skin symptoms of psoriatic arthritis in a pivotal phase-III clinical trial.

"This will be the basis for seeking regulatory approval for this drug in the treatment of psoriatic arthritis. It’s a very important development because we don’t have quite the armamentarium of drugs for treating psoriatic arthritis that we do in treating rheumatoid arthritis," Dr. Philip J. Mease observed when he presented the results of the study, known as RAPID-PsA, at the annual European Congress of Rheumatology.

The ACR 20, ACR 50, and ACR 70 responses (that is, 20%, 50%, and 70% improvements, respectively, in certain parameters specified by the American College of Rheumatology) to certolizumab were two- to fourfold higher than in placebo-treated controls. Also impressive were the proportion of certolizumab-treated patients with at least a PASI 75 (that is, a 75% improvement in the Psoriasis Area and Severity Index), as well as the documented improvement in physical functioning. But perhaps most striking of all was the kinetics of the response to certolizumab.

"As early as 1 week with this agent, it separates from placebo. There’s a very fast onset of action with certolizumab," noted Dr. Mease of the University of Washington, Seattle.

The 24-week, three-armed, phase III, double-blind clinical trial included 409 psoriatic arthritis (PsA) patients. They were randomized to placebo or to a loading dose of 400 mg of subcutaneous certolizumab (Cimzia) at weeks 0, 2, and 4, then were further randomized to continue certolizumab at either 200 mg every 2 weeks or 400 mg every 4 weeks.

These patients had severe PsA, with a mean baseline of 20 tender and 11 swollen joints. Nearly two-thirds of subjects had enthesitis and one-third had dactylitis. Their median baseline PASI was in the 7-8 range, with C-reactive protein levels ranging from 7 mg/L to 9 mg/L. All subjects had failed at least one disease-modifying antirheumatic drug, and about half had failed two or more. Moreover, 20% of subjects had previously received a TNF inhibitor that over time had become ineffective.

"That makes it presumably tougher to achieve the kinds of responses we see in most other trials where patients are required to be naive to anti-TNF medications. But this design more approximates a real-world situation in which some of the patients you’re treating receive certolizumab as first-line therapy, but others may receive it as second- or third-line anti-TNF medication," the rheumatologist explained.

The ACR 20 response to the pegylated humanized TNF inhibitor at week 12 (the prespecified primary study end point) was closely similar in the twice-monthly and once-monthly dosing groups, as was the ACR 50 response. However, the twice-monthly 200-mg regimen was superior at achieving ACR 70. (See box.)

Skin responses were "quite robust," Dr. Mease declared. At week 12, among patients with at least 3% body surface area involvement at baseline, PASI 75 responses were documented in 47% of patients in either of the certolizumab arms, compared with 14% of placebo-treated controls. At week 24, PASI 75 responses were noted in 62% of patients on twice-monthly certolizumab, in 61% of those on once-monthly therapy, and in 15% of controls.

Improved physical functioning was reflected in a mean 0.54-point reduction at week 24 from a mean baseline HAQ-DI (Health Assessment Questionnaire-Disease Index) score of 1.3 in the twice-monthly certolizumab group and a 0.46-point decrease with once-monthly therapy, both of which were well beyond the 0.35-point reduction threshold conventionally deemed to be a minimally clinically important improvement. In contrast, HAQ-DI scores decreased by a mean of only 0.19 points in the control group.

Side effects were the same as those seen in the treatment of rheumatoid arthritis, for which certolizumab is approved in the United States and Europe with the same dosing choices.

"No new safety news," Dr. Mease commented.

He noted that he was presenting a first look at the RAPID-PsA results. Later this year at the annual meeting of the American College of Rheumatology, he and his coinvestigators will be able to share the results of ongoing analyses of the radiographic response to treatment, as well as certolizumab’s ability to treat enthesitis and dactylitis.

Dr. Mease predicted that the dosing that’s ultimately approved for PsA will mimic that used in RA, offering patients the flexibility to choose between once- and twice-monthly therapy.

Psoriasis occurs in about 2.1% of the general population worldwide. Roughly 30% of affected patients also have PsA.

"This is one of the most devastating diseases a person can have because not only does it feature the functional impairment of a musculoskeletal disease but also the embarrassing cosmetic problems of psoriasis. Psoriatic arthritis is one of the few diseases we work with in rheumatology where suicide is one of the reasons for increased early mortality," Dr. Mease said.

Dr. Mease reported financial relation ships with UCB, which markets certolizumab. In addition, as a clinical trialist he has financial relationships with numerous other pharmaceutical companies that are interested in rheumatologic diseases.

BERLIN – The tumor necrosis factor inhibitor certolizumab pegol significantly lessened both joint and skin symptoms of psoriatic arthritis in a pivotal phase-III clinical trial.

"This will be the basis for seeking regulatory approval for this drug in the treatment of psoriatic arthritis. It’s a very important development because we don’t have quite the armamentarium of drugs for treating psoriatic arthritis that we do in treating rheumatoid arthritis," Dr. Philip J. Mease observed when he presented the results of the study, known as RAPID-PsA, at the annual European Congress of Rheumatology.

The ACR 20, ACR 50, and ACR 70 responses (that is, 20%, 50%, and 70% improvements, respectively, in certain parameters specified by the American College of Rheumatology) to certolizumab were two- to fourfold higher than in placebo-treated controls. Also impressive were the proportion of certolizumab-treated patients with at least a PASI 75 (that is, a 75% improvement in the Psoriasis Area and Severity Index), as well as the documented improvement in physical functioning. But perhaps most striking of all was the kinetics of the response to certolizumab.

"As early as 1 week with this agent, it separates from placebo. There’s a very fast onset of action with certolizumab," noted Dr. Mease of the University of Washington, Seattle.

The 24-week, three-armed, phase III, double-blind clinical trial included 409 psoriatic arthritis (PsA) patients. They were randomized to placebo or to a loading dose of 400 mg of subcutaneous certolizumab (Cimzia) at weeks 0, 2, and 4, then were further randomized to continue certolizumab at either 200 mg every 2 weeks or 400 mg every 4 weeks.

These patients had severe PsA, with a mean baseline of 20 tender and 11 swollen joints. Nearly two-thirds of subjects had enthesitis and one-third had dactylitis. Their median baseline PASI was in the 7-8 range, with C-reactive protein levels ranging from 7 mg/L to 9 mg/L. All subjects had failed at least one disease-modifying antirheumatic drug, and about half had failed two or more. Moreover, 20% of subjects had previously received a TNF inhibitor that over time had become ineffective.

"That makes it presumably tougher to achieve the kinds of responses we see in most other trials where patients are required to be naive to anti-TNF medications. But this design more approximates a real-world situation in which some of the patients you’re treating receive certolizumab as first-line therapy, but others may receive it as second- or third-line anti-TNF medication," the rheumatologist explained.

The ACR 20 response to the pegylated humanized TNF inhibitor at week 12 (the prespecified primary study end point) was closely similar in the twice-monthly and once-monthly dosing groups, as was the ACR 50 response. However, the twice-monthly 200-mg regimen was superior at achieving ACR 70. (See box.)

Skin responses were "quite robust," Dr. Mease declared. At week 12, among patients with at least 3% body surface area involvement at baseline, PASI 75 responses were documented in 47% of patients in either of the certolizumab arms, compared with 14% of placebo-treated controls. At week 24, PASI 75 responses were noted in 62% of patients on twice-monthly certolizumab, in 61% of those on once-monthly therapy, and in 15% of controls.

Improved physical functioning was reflected in a mean 0.54-point reduction at week 24 from a mean baseline HAQ-DI (Health Assessment Questionnaire-Disease Index) score of 1.3 in the twice-monthly certolizumab group and a 0.46-point decrease with once-monthly therapy, both of which were well beyond the 0.35-point reduction threshold conventionally deemed to be a minimally clinically important improvement. In contrast, HAQ-DI scores decreased by a mean of only 0.19 points in the control group.

Side effects were the same as those seen in the treatment of rheumatoid arthritis, for which certolizumab is approved in the United States and Europe with the same dosing choices.

"No new safety news," Dr. Mease commented.

He noted that he was presenting a first look at the RAPID-PsA results. Later this year at the annual meeting of the American College of Rheumatology, he and his coinvestigators will be able to share the results of ongoing analyses of the radiographic response to treatment, as well as certolizumab’s ability to treat enthesitis and dactylitis.

Dr. Mease predicted that the dosing that’s ultimately approved for PsA will mimic that used in RA, offering patients the flexibility to choose between once- and twice-monthly therapy.

Psoriasis occurs in about 2.1% of the general population worldwide. Roughly 30% of affected patients also have PsA.

"This is one of the most devastating diseases a person can have because not only does it feature the functional impairment of a musculoskeletal disease but also the embarrassing cosmetic problems of psoriasis. Psoriatic arthritis is one of the few diseases we work with in rheumatology where suicide is one of the reasons for increased early mortality," Dr. Mease said.

Dr. Mease reported financial relation ships with UCB, which markets certolizumab. In addition, as a clinical trialist he has financial relationships with numerous other pharmaceutical companies that are interested in rheumatologic diseases.

BERLIN – Consistent daily use of full-dose NSAIDs significantly slows radiographic spinal progression in ankylosing spondylitis patients but only in the subgroup with risk factors for progression – namely, syndesmophytes and elevated C-reactive protein or erythrocyte sedimentation rate.

Ankylosing spondylitis (AS) patients without these risk factors have such a low rate of radiographic spinal progression over 2 years of follow-up that their risk is unaffected by how consistently they use NSAIDs, Dr. Denis Poddubnyy reported at the annual European Congress of Rheumatology.

These conclusions are based on two studies presented at the meeting: one by Dr. Poddubnyy involving participants in a prospective registry known as the German Spondyloarthritis Inception Cohort, and the other a new post hoc analysis of data from the first, and to date the only, randomized controlled trial of the impact of consistently high versus as-needed use of NSAIDs on radiographic spinal progression in patients with AS.

"I think these data might change future treatment guidelines as we move along the way to more individualized treatment for patients with ankylosing spondylitis. Symptomatic patients who require NSAIDs would benefit most from the medication if they also have risk factors associated with radiographic progression," said Dr. Poddubnyy of Charité Hospital in Berlin.

He presented a study of 164 German registry participants, all with definite early axial spondyloarthritis. Eighty-eight patients met diagnostic criteria for axial AS, and the other 76 had nonradiographic axial spondyloarthritis. They were selected from the registry because they all had 2 years of serial spinal x-rays and detailed information on their NSAID use during that period. Axial spinal x-rays were independently assessed by two blinded readers using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). NSAID intake was rated using a scoring system developed by the Assessment of Spondylarthritis International Society (Ann. Rheum. Dis. 2011;70:249-51).

Sixty-four AS patients were categorized as having low NSAID intake, defined as less than 50% of daily full-dose use. These patients took NSAIDs on an as-needed basis. They had a substantial rate of radiographic progression of their spinal disease: a mean 0.96-point increase in mSASSS over the course of 2 years from a baseline score of about 6. In contrast, patients with high NSAID intake – that is, at least 50% of full-dose therapy 7 days a week – had virtually no radiographic progression, with a mean 0.02-point increase. Consistent use of full-dose NSAIDs had a beneficial structure-modifying effect on new bone formation, the rheumatologist observed.

A multivariate logistic regression analysis identified two independent risk factors for substantial radiographic spinal progression: the presence of syndesmophytes on the baseline spinal x-ray and a consistently elevated C-reactive protein (CRP) level. Baseline syndesmophytes were by far the most potent risk factor, with an associated 6.8-fold increased risk. AS patients with one or both of these risk factors and low NSAID intake averaged a 4.36-point increase in mSASSS scores over 2 years, while high NSAID users with risk factors averaged a nonsignificant 0.14-point increase.

"Remarkably, in patients without risk factors for progression we saw nearly no progression, and no difference between high and low NSAID intake," according to Dr. Poddubnyy.

In response to an audience question, he estimated that about 30% of AS patients have risk factors for radiographic spinal progression.

In the 76 registry patients with nonradiographic axial spondyloarthritis, the level of NSAID use made no difference in terms of the rate of change in mSASSS scores. "At this stage, radiographic progression in these patients is probably due to forces other than new bone formation," he explained.

Dr. Poddubnyy noted that while this was not a randomized trial, the registry findings were confirmed in another study presented during the congress. This was a Dutch post hoc secondary analysis of data from the only randomized prospective clinical trial to date demonstrating that continuous NSAID intake over a 2-year period was associated with significantly less radiographic spinal progression than as-needed use (Arthritis Rheum. 2005;52:1756-65).

The new post hoc analysis of 150 AS patients randomized to continuous or as-needed celecoxib showed that retardation of radiographic spinal progression through high intake of NSAIDs was essentially confined to patients with either of two baseline risk factors for radiographic progression: a consistently elevated CRP or an elevated erythrocyte sedimentation rate (ESR).

The Dutch investigators found that patients with a high baseline CRP had a 13% rate of substantial radiographic disease progression during 2 years if they used celecoxib continuously compared with a 38% rate with as-needed use. Those with an elevated ESR had a 22% risk of substantial progression if they used the NSAID continuously but a 49% risk if they took celecoxib on an as-needed basis.

These two studies, Dr. Poddubnyy continued, point the way toward maximizing the risk/benefit ratio of NSAID therapy in patients with AS.

The German registry study was funded by the German Rheumatism Research Center of Berlin. Dr. Poddubnyy reported having no financial conflicts.

BERLIN – Consistent daily use of full-dose NSAIDs significantly slows radiographic spinal progression in ankylosing spondylitis patients but only in the subgroup with risk factors for progression – namely, syndesmophytes and elevated C-reactive protein or erythrocyte sedimentation rate.

Ankylosing spondylitis (AS) patients without these risk factors have such a low rate of radiographic spinal progression over 2 years of follow-up that their risk is unaffected by how consistently they use NSAIDs, Dr. Denis Poddubnyy reported at the annual European Congress of Rheumatology.

These conclusions are based on two studies presented at the meeting: one by Dr. Poddubnyy involving participants in a prospective registry known as the German Spondyloarthritis Inception Cohort, and the other a new post hoc analysis of data from the first, and to date the only, randomized controlled trial of the impact of consistently high versus as-needed use of NSAIDs on radiographic spinal progression in patients with AS.

"I think these data might change future treatment guidelines as we move along the way to more individualized treatment for patients with ankylosing spondylitis. Symptomatic patients who require NSAIDs would benefit most from the medication if they also have risk factors associated with radiographic progression," said Dr. Poddubnyy of Charité Hospital in Berlin.

He presented a study of 164 German registry participants, all with definite early axial spondyloarthritis. Eighty-eight patients met diagnostic criteria for axial AS, and the other 76 had nonradiographic axial spondyloarthritis. They were selected from the registry because they all had 2 years of serial spinal x-rays and detailed information on their NSAID use during that period. Axial spinal x-rays were independently assessed by two blinded readers using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). NSAID intake was rated using a scoring system developed by the Assessment of Spondylarthritis International Society (Ann. Rheum. Dis. 2011;70:249-51).

Sixty-four AS patients were categorized as having low NSAID intake, defined as less than 50% of daily full-dose use. These patients took NSAIDs on an as-needed basis. They had a substantial rate of radiographic progression of their spinal disease: a mean 0.96-point increase in mSASSS over the course of 2 years from a baseline score of about 6. In contrast, patients with high NSAID intake – that is, at least 50% of full-dose therapy 7 days a week – had virtually no radiographic progression, with a mean 0.02-point increase. Consistent use of full-dose NSAIDs had a beneficial structure-modifying effect on new bone formation, the rheumatologist observed.

A multivariate logistic regression analysis identified two independent risk factors for substantial radiographic spinal progression: the presence of syndesmophytes on the baseline spinal x-ray and a consistently elevated C-reactive protein (CRP) level. Baseline syndesmophytes were by far the most potent risk factor, with an associated 6.8-fold increased risk. AS patients with one or both of these risk factors and low NSAID intake averaged a 4.36-point increase in mSASSS scores over 2 years, while high NSAID users with risk factors averaged a nonsignificant 0.14-point increase.

"Remarkably, in patients without risk factors for progression we saw nearly no progression, and no difference between high and low NSAID intake," according to Dr. Poddubnyy.

In response to an audience question, he estimated that about 30% of AS patients have risk factors for radiographic spinal progression.

In the 76 registry patients with nonradiographic axial spondyloarthritis, the level of NSAID use made no difference in terms of the rate of change in mSASSS scores. "At this stage, radiographic progression in these patients is probably due to forces other than new bone formation," he explained.

Dr. Poddubnyy noted that while this was not a randomized trial, the registry findings were confirmed in another study presented during the congress. This was a Dutch post hoc secondary analysis of data from the only randomized prospective clinical trial to date demonstrating that continuous NSAID intake over a 2-year period was associated with significantly less radiographic spinal progression than as-needed use (Arthritis Rheum. 2005;52:1756-65).

The new post hoc analysis of 150 AS patients randomized to continuous or as-needed celecoxib showed that retardation of radiographic spinal progression through high intake of NSAIDs was essentially confined to patients with either of two baseline risk factors for radiographic progression: a consistently elevated CRP or an elevated erythrocyte sedimentation rate (ESR).

The Dutch investigators found that patients with a high baseline CRP had a 13% rate of substantial radiographic disease progression during 2 years if they used celecoxib continuously compared with a 38% rate with as-needed use. Those with an elevated ESR had a 22% risk of substantial progression if they used the NSAID continuously but a 49% risk if they took celecoxib on an as-needed basis.

These two studies, Dr. Poddubnyy continued, point the way toward maximizing the risk/benefit ratio of NSAID therapy in patients with AS.

The German registry study was funded by the German Rheumatism Research Center of Berlin. Dr. Poddubnyy reported having no financial conflicts.

BERLIN – Consistent daily use of full-dose NSAIDs significantly slows radiographic spinal progression in ankylosing spondylitis patients but only in the subgroup with risk factors for progression – namely, syndesmophytes and elevated C-reactive protein or erythrocyte sedimentation rate.

Ankylosing spondylitis (AS) patients without these risk factors have such a low rate of radiographic spinal progression over 2 years of follow-up that their risk is unaffected by how consistently they use NSAIDs, Dr. Denis Poddubnyy reported at the annual European Congress of Rheumatology.

These conclusions are based on two studies presented at the meeting: one by Dr. Poddubnyy involving participants in a prospective registry known as the German Spondyloarthritis Inception Cohort, and the other a new post hoc analysis of data from the first, and to date the only, randomized controlled trial of the impact of consistently high versus as-needed use of NSAIDs on radiographic spinal progression in patients with AS.

"I think these data might change future treatment guidelines as we move along the way to more individualized treatment for patients with ankylosing spondylitis. Symptomatic patients who require NSAIDs would benefit most from the medication if they also have risk factors associated with radiographic progression," said Dr. Poddubnyy of Charité Hospital in Berlin.

He presented a study of 164 German registry participants, all with definite early axial spondyloarthritis. Eighty-eight patients met diagnostic criteria for axial AS, and the other 76 had nonradiographic axial spondyloarthritis. They were selected from the registry because they all had 2 years of serial spinal x-rays and detailed information on their NSAID use during that period. Axial spinal x-rays were independently assessed by two blinded readers using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). NSAID intake was rated using a scoring system developed by the Assessment of Spondylarthritis International Society (Ann. Rheum. Dis. 2011;70:249-51).

Sixty-four AS patients were categorized as having low NSAID intake, defined as less than 50% of daily full-dose use. These patients took NSAIDs on an as-needed basis. They had a substantial rate of radiographic progression of their spinal disease: a mean 0.96-point increase in mSASSS over the course of 2 years from a baseline score of about 6. In contrast, patients with high NSAID intake – that is, at least 50% of full-dose therapy 7 days a week – had virtually no radiographic progression, with a mean 0.02-point increase. Consistent use of full-dose NSAIDs had a beneficial structure-modifying effect on new bone formation, the rheumatologist observed.

A multivariate logistic regression analysis identified two independent risk factors for substantial radiographic spinal progression: the presence of syndesmophytes on the baseline spinal x-ray and a consistently elevated C-reactive protein (CRP) level. Baseline syndesmophytes were by far the most potent risk factor, with an associated 6.8-fold increased risk. AS patients with one or both of these risk factors and low NSAID intake averaged a 4.36-point increase in mSASSS scores over 2 years, while high NSAID users with risk factors averaged a nonsignificant 0.14-point increase.

"Remarkably, in patients without risk factors for progression we saw nearly no progression, and no difference between high and low NSAID intake," according to Dr. Poddubnyy.

In response to an audience question, he estimated that about 30% of AS patients have risk factors for radiographic spinal progression.

In the 76 registry patients with nonradiographic axial spondyloarthritis, the level of NSAID use made no difference in terms of the rate of change in mSASSS scores. "At this stage, radiographic progression in these patients is probably due to forces other than new bone formation," he explained.

Dr. Poddubnyy noted that while this was not a randomized trial, the registry findings were confirmed in another study presented during the congress. This was a Dutch post hoc secondary analysis of data from the only randomized prospective clinical trial to date demonstrating that continuous NSAID intake over a 2-year period was associated with significantly less radiographic spinal progression than as-needed use (Arthritis Rheum. 2005;52:1756-65).

The new post hoc analysis of 150 AS patients randomized to continuous or as-needed celecoxib showed that retardation of radiographic spinal progression through high intake of NSAIDs was essentially confined to patients with either of two baseline risk factors for radiographic progression: a consistently elevated CRP or an elevated erythrocyte sedimentation rate (ESR).

The Dutch investigators found that patients with a high baseline CRP had a 13% rate of substantial radiographic disease progression during 2 years if they used celecoxib continuously compared with a 38% rate with as-needed use. Those with an elevated ESR had a 22% risk of substantial progression if they used the NSAID continuously but a 49% risk if they took celecoxib on an as-needed basis.

These two studies, Dr. Poddubnyy continued, point the way toward maximizing the risk/benefit ratio of NSAID therapy in patients with AS.

The German registry study was funded by the German Rheumatism Research Center of Berlin. Dr. Poddubnyy reported having no financial conflicts.

BERLIN – Obese patients with psoriatic arthritis demonstrate a worse response when starting anti–tumor necrosis factor therapy than do normal weight patients, but achievement of minimal disease activity can be improved by weight loss, based on two studies by Dr. Giovanni Di Minno, lead investigator on both.

The first study investigated the influence of obesity and the second, the influence of weight loss on response to starting anti–tumor necrosis factor (TNF) therapy.

The study on the effect of obesity on response to anti-TNF therapy in psoriatic arthritis (PsA) involved 135 psoriatic arthritis patients with a body mass index (BMI) over 30 kg/m²and 135 normal weight controls. Dr. Di Minno and his coinvestigators found that the two groups did not differ significantly in terms of disease activity and vascular risk factors including swollen and tender joint counts, levels of C-reactive protein, erythrocyte sedimentation rates, and psoriasis area severity index scores. They found that patients with a BMI over 30 had a higher prevalence of hypercholesterolemia and hypertriglyceridemia.

"Controlling weight is very important for these patients in the long term."

Dr. Di Minno and his associates in the department of clinical and experimental medicine, Federico II University, Naples, Italy, found that at 12 months’ follow-up, 98 of the 270 patients (36.3%) had achieved minimal disease activity (MDA). The prevalence of obesity was higher in those not achieving MDA than in those achieving it (64% vs. 25.5%, P less than .001).

"A BMI of over 30 was shown to be a strong predictor [of not achieving MDA] with a hazard ratio of 4.90 (95%CI: 3.04-7.87; P less than .001)," according to Cox regression analysis findings, reported Dr. Di Minno.

At 24 months, 17.3% of those who achieved MDA a year earlier relapsed, and 82.7% maintained their MDA. "A BMI greater than 30 was associated with a higher risk of disease relapse, with a hazard ratio of 2.04 [95% CI: 1.02-3.61; P = .014]," he said at the annual European Congress of Rheumatology.

Dr. Di Minno also noted that there was no difference found between the three anti-TNF blockers (infliximab, etanercept, and adalimumab) used in the study.

Session moderator Dr. Laura Coates said that the study was valuable because patients with PsA were prone to being overweight, and there was an established link between excess weight, metabolic syndrome, and psoriasis. "Until this study, there were no data to support the concept that weight loss could alter people’s outcome in terms of their arthritis response.

"This provides evidence of an immediate improvement to people’s health with weight loss, in terms of a better response to the anti-TNF therapies," said Dr. Coates of the division of rheumatic and musculoskeletal disease at Chapel Allerton Hospital in Leeds, England.

Furthermore, Dr. Coates noted that there was also a known association between psoriasis/PsA and cardiovascular morbidity related to the metabolic syndrome. "Controlling weight is very important for these patients in the long term as well," she said.

Introducing his second study, which investigated the effect of weight loss in obese patients, Dr Di Minno noted that prior studies had shown that restricting calorie intake reduced obesity-related inflammation.

The study specifically investigated the impact of changes in body weight on the achievement of MDA in PsA patients starting treatment on anti-TNF therapy.

A total of 126 obese (BMI greater than 30) patients with active PsA, who had not responded to traditional disease-modifying antirheumaic drugs were randomized to either a diet of 1,300 calories per day (n = 63), or an unrestricted diet (n = 63), with the advice to eat more vegetables, fish, and fresh fruits and no more than 2 tablespoons of olive oil per day. All patients were encouraged to exercise five times a week, and all started on anti-TNF therapy immediately.

"The intervention diet was the traditional Mediterranean diet rich in fibers, with a careful balance of sugar, proteins, and lipids, similar to the diet used by diabetics," explained Dr. Di Minno. The Mediterranean diet has been shown to lessen inflammation because it is rich in mono- and polyunsaturated fatty acids, antioxidants, dietary fiber, and phytochemicals.

At the 6-month follow-up, the researchers found a 5%-10% weight loss was achieved by 47.6% of patients on the hypocaloric diet versus 28.6% on the unrestricted diet. Only 41.3% of patients on the hypocaloric diet lost more than 10% of their body weight.

Furthermore, patients on the hypocaloric diet had more significant reductions in triglycerides and cholesterol compared with those on the unrestricted diet (29.1% vs. 10% for triglycerides. and 23.7% vs. 8.1% for cholesterol, for hypocaloric and unrestricted diets, respectively).

"To our surprise we found that the Mediterranean diet was not much better than the other diet in terms of MDA achievement [42.9% on the hypocaloric diet vs. 34.9% on the free diet; P = .465]," reported Dr. Di Minno.

MDA was achieved more frequently by patients who achieved a greater than 5% weight loss compared with those who did not [50% vs. 23.1%]. Furthermore, as weight loss increased so did the achievement of MDA, with 16.7%, 42.9%, and 59.5% MDA achievement for a weight loss of less than 5%, 5%-10%, and more than 10%, respectively.

The data strongly support the need for the control of body weight and cardiometabolic parameters in PsA subjects starting anti-TNF treatment, Dr. Di Minno said. "This may result in a better achievement of minimal disease activity in these patients."

Dr. Di Minno and Dr. Coates reported having no relevant financial conflicts.

BERLIN – Obese patients with psoriatic arthritis demonstrate a worse response when starting anti–tumor necrosis factor therapy than do normal weight patients, but achievement of minimal disease activity can be improved by weight loss, based on two studies by Dr. Giovanni Di Minno, lead investigator on both.

The first study investigated the influence of obesity and the second, the influence of weight loss on response to starting anti–tumor necrosis factor (TNF) therapy.

The study on the effect of obesity on response to anti-TNF therapy in psoriatic arthritis (PsA) involved 135 psoriatic arthritis patients with a body mass index (BMI) over 30 kg/m²and 135 normal weight controls. Dr. Di Minno and his coinvestigators found that the two groups did not differ significantly in terms of disease activity and vascular risk factors including swollen and tender joint counts, levels of C-reactive protein, erythrocyte sedimentation rates, and psoriasis area severity index scores. They found that patients with a BMI over 30 had a higher prevalence of hypercholesterolemia and hypertriglyceridemia.

"Controlling weight is very important for these patients in the long term."

Dr. Di Minno and his associates in the department of clinical and experimental medicine, Federico II University, Naples, Italy, found that at 12 months’ follow-up, 98 of the 270 patients (36.3%) had achieved minimal disease activity (MDA). The prevalence of obesity was higher in those not achieving MDA than in those achieving it (64% vs. 25.5%, P less than .001).

"A BMI of over 30 was shown to be a strong predictor [of not achieving MDA] with a hazard ratio of 4.90 (95%CI: 3.04-7.87; P less than .001)," according to Cox regression analysis findings, reported Dr. Di Minno.

At 24 months, 17.3% of those who achieved MDA a year earlier relapsed, and 82.7% maintained their MDA. "A BMI greater than 30 was associated with a higher risk of disease relapse, with a hazard ratio of 2.04 [95% CI: 1.02-3.61; P = .014]," he said at the annual European Congress of Rheumatology.

Dr. Di Minno also noted that there was no difference found between the three anti-TNF blockers (infliximab, etanercept, and adalimumab) used in the study.

Session moderator Dr. Laura Coates said that the study was valuable because patients with PsA were prone to being overweight, and there was an established link between excess weight, metabolic syndrome, and psoriasis. "Until this study, there were no data to support the concept that weight loss could alter people’s outcome in terms of their arthritis response.

"This provides evidence of an immediate improvement to people’s health with weight loss, in terms of a better response to the anti-TNF therapies," said Dr. Coates of the division of rheumatic and musculoskeletal disease at Chapel Allerton Hospital in Leeds, England.

Furthermore, Dr. Coates noted that there was also a known association between psoriasis/PsA and cardiovascular morbidity related to the metabolic syndrome. "Controlling weight is very important for these patients in the long term as well," she said.

Introducing his second study, which investigated the effect of weight loss in obese patients, Dr Di Minno noted that prior studies had shown that restricting calorie intake reduced obesity-related inflammation.

The study specifically investigated the impact of changes in body weight on the achievement of MDA in PsA patients starting treatment on anti-TNF therapy.

A total of 126 obese (BMI greater than 30) patients with active PsA, who had not responded to traditional disease-modifying antirheumaic drugs were randomized to either a diet of 1,300 calories per day (n = 63), or an unrestricted diet (n = 63), with the advice to eat more vegetables, fish, and fresh fruits and no more than 2 tablespoons of olive oil per day. All patients were encouraged to exercise five times a week, and all started on anti-TNF therapy immediately.

"The intervention diet was the traditional Mediterranean diet rich in fibers, with a careful balance of sugar, proteins, and lipids, similar to the diet used by diabetics," explained Dr. Di Minno. The Mediterranean diet has been shown to lessen inflammation because it is rich in mono- and polyunsaturated fatty acids, antioxidants, dietary fiber, and phytochemicals.

At the 6-month follow-up, the researchers found a 5%-10% weight loss was achieved by 47.6% of patients on the hypocaloric diet versus 28.6% on the unrestricted diet. Only 41.3% of patients on the hypocaloric diet lost more than 10% of their body weight.

Furthermore, patients on the hypocaloric diet had more significant reductions in triglycerides and cholesterol compared with those on the unrestricted diet (29.1% vs. 10% for triglycerides. and 23.7% vs. 8.1% for cholesterol, for hypocaloric and unrestricted diets, respectively).

"To our surprise we found that the Mediterranean diet was not much better than the other diet in terms of MDA achievement [42.9% on the hypocaloric diet vs. 34.9% on the free diet; P = .465]," reported Dr. Di Minno.

MDA was achieved more frequently by patients who achieved a greater than 5% weight loss compared with those who did not [50% vs. 23.1%]. Furthermore, as weight loss increased so did the achievement of MDA, with 16.7%, 42.9%, and 59.5% MDA achievement for a weight loss of less than 5%, 5%-10%, and more than 10%, respectively.

The data strongly support the need for the control of body weight and cardiometabolic parameters in PsA subjects starting anti-TNF treatment, Dr. Di Minno said. "This may result in a better achievement of minimal disease activity in these patients."

Dr. Di Minno and Dr. Coates reported having no relevant financial conflicts.

BERLIN – Obese patients with psoriatic arthritis demonstrate a worse response when starting anti–tumor necrosis factor therapy than do normal weight patients, but achievement of minimal disease activity can be improved by weight loss, based on two studies by Dr. Giovanni Di Minno, lead investigator on both.

The first study investigated the influence of obesity and the second, the influence of weight loss on response to starting anti–tumor necrosis factor (TNF) therapy.

The study on the effect of obesity on response to anti-TNF therapy in psoriatic arthritis (PsA) involved 135 psoriatic arthritis patients with a body mass index (BMI) over 30 kg/m²and 135 normal weight controls. Dr. Di Minno and his coinvestigators found that the two groups did not differ significantly in terms of disease activity and vascular risk factors including swollen and tender joint counts, levels of C-reactive protein, erythrocyte sedimentation rates, and psoriasis area severity index scores. They found that patients with a BMI over 30 had a higher prevalence of hypercholesterolemia and hypertriglyceridemia.

"Controlling weight is very important for these patients in the long term."

Dr. Di Minno and his associates in the department of clinical and experimental medicine, Federico II University, Naples, Italy, found that at 12 months’ follow-up, 98 of the 270 patients (36.3%) had achieved minimal disease activity (MDA). The prevalence of obesity was higher in those not achieving MDA than in those achieving it (64% vs. 25.5%, P less than .001).

"A BMI of over 30 was shown to be a strong predictor [of not achieving MDA] with a hazard ratio of 4.90 (95%CI: 3.04-7.87; P less than .001)," according to Cox regression analysis findings, reported Dr. Di Minno.

At 24 months, 17.3% of those who achieved MDA a year earlier relapsed, and 82.7% maintained their MDA. "A BMI greater than 30 was associated with a higher risk of disease relapse, with a hazard ratio of 2.04 [95% CI: 1.02-3.61; P = .014]," he said at the annual European Congress of Rheumatology.

Dr. Di Minno also noted that there was no difference found between the three anti-TNF blockers (infliximab, etanercept, and adalimumab) used in the study.

Session moderator Dr. Laura Coates said that the study was valuable because patients with PsA were prone to being overweight, and there was an established link between excess weight, metabolic syndrome, and psoriasis. "Until this study, there were no data to support the concept that weight loss could alter people’s outcome in terms of their arthritis response.

"This provides evidence of an immediate improvement to people’s health with weight loss, in terms of a better response to the anti-TNF therapies," said Dr. Coates of the division of rheumatic and musculoskeletal disease at Chapel Allerton Hospital in Leeds, England.

Furthermore, Dr. Coates noted that there was also a known association between psoriasis/PsA and cardiovascular morbidity related to the metabolic syndrome. "Controlling weight is very important for these patients in the long term as well," she said.

Introducing his second study, which investigated the effect of weight loss in obese patients, Dr Di Minno noted that prior studies had shown that restricting calorie intake reduced obesity-related inflammation.

The study specifically investigated the impact of changes in body weight on the achievement of MDA in PsA patients starting treatment on anti-TNF therapy.

A total of 126 obese (BMI greater than 30) patients with active PsA, who had not responded to traditional disease-modifying antirheumaic drugs were randomized to either a diet of 1,300 calories per day (n = 63), or an unrestricted diet (n = 63), with the advice to eat more vegetables, fish, and fresh fruits and no more than 2 tablespoons of olive oil per day. All patients were encouraged to exercise five times a week, and all started on anti-TNF therapy immediately.

"The intervention diet was the traditional Mediterranean diet rich in fibers, with a careful balance of sugar, proteins, and lipids, similar to the diet used by diabetics," explained Dr. Di Minno. The Mediterranean diet has been shown to lessen inflammation because it is rich in mono- and polyunsaturated fatty acids, antioxidants, dietary fiber, and phytochemicals.

At the 6-month follow-up, the researchers found a 5%-10% weight loss was achieved by 47.6% of patients on the hypocaloric diet versus 28.6% on the unrestricted diet. Only 41.3% of patients on the hypocaloric diet lost more than 10% of their body weight.

Furthermore, patients on the hypocaloric diet had more significant reductions in triglycerides and cholesterol compared with those on the unrestricted diet (29.1% vs. 10% for triglycerides. and 23.7% vs. 8.1% for cholesterol, for hypocaloric and unrestricted diets, respectively).

"To our surprise we found that the Mediterranean diet was not much better than the other diet in terms of MDA achievement [42.9% on the hypocaloric diet vs. 34.9% on the free diet; P = .465]," reported Dr. Di Minno.

MDA was achieved more frequently by patients who achieved a greater than 5% weight loss compared with those who did not [50% vs. 23.1%]. Furthermore, as weight loss increased so did the achievement of MDA, with 16.7%, 42.9%, and 59.5% MDA achievement for a weight loss of less than 5%, 5%-10%, and more than 10%, respectively.

The data strongly support the need for the control of body weight and cardiometabolic parameters in PsA subjects starting anti-TNF treatment, Dr. Di Minno said. "This may result in a better achievement of minimal disease activity in these patients."

Dr. Di Minno and Dr. Coates reported having no relevant financial conflicts.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

BERLIN – Comprehensive feedback from patients and clinicians indicates that the American College of Rheumatology’s core set of criteria for rheumatoid arthritis may need to be expanded to include patient-centered domains such as stiffness, self-management, and participation to measure disease flare.

With no established definition for flare, the OMERACT (Outcomes Measure in Rheumatology) Rheumatoid Arthritis Flare Group developed a working framework of flare based on patient self-report of disease worsening. Next, they put the preliminary symptom domains to the test in a comparison study, the results of which Dr. Elisabeth Lie presented at the annual European Congress of Rheumatology.

"Among clinicians and patients, episodes of disease worsening or flare are a recognized aspect of the rheumatoid arthritis disease process," Dr. Lie said. "Currently there is no established definition of flare or standardized method to measure flare."

"The aim is to develop a data-driven, patient-centered, and consensus-based definition of flare in rheumatoid arthritis for use in clinical trials ... as well as in clinical practice."

Participants were asked, "Since the start of treatment in this follow-up study, has your rheumatic disease improved, remained unchanged, or deteriorated?"

When the DAS28 (Disease Assessment Score with a 28-joint count) was used, "there was a significant difference in change at 6 months for flare versus no flare based on patient reported worsening," Dr. Lie said. Effects were larger using this working definition compared with a flare definition based on treatment change or a definition using both criteria, she added.

The preliminary symptom domains discriminated well between patients with and without worsening flare in the domains of pain and stiffness, according to Dr. Lie of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

"The working definition of flare based on patient-reported worsening discriminated well between patients with and without worsening in most domains, especially those related to pain and function," Dr. Lie said.

For joint pain visual analog scale scores, the standardized mean difference (SMD) between flare and no flare was 1.30. The Short Form-36 Bodily Pain questionnaire yielded a 1.24 SMD between groups. Intensity of morning stiffness was associated with a 1.17 SMD.

Dr. Lie and her colleagues assessed 1,195 patients in the NOR-DMARD register who, according to a 5-point Likert scale, reported that they initially were "much improved" or "improved" 3 months after initiating RA treatment. At 6 months, the 79 of these patients who reported that they were "worse" or "much worse" accounted for the flare group.

"Importantly, the RA flare group has developed a preliminary flare questionnaire that is currently being applied in two randomized clinical trials and three observational studies," Dr. Lie said in an interview. "This questionnaire addresses all the important domains identified as essential by patients, and data from these studies will be very important to further the process to develop a preliminary patient-reported instrument to measure RA flare."

"The involvement of patients in the early phases of this work revealed that flares are a common occurrence in patients with RA and likely represent an underrecognized aspect of the disease experience," Dr. Lie said. "Focus groups also revealed the complexity of the flare concept and the heterogeneity of clusters of symptoms that may constitute a flare."

"I think it is fair to say that rheumatologists should pay attention to patient report of flare, especially as milder flares occurring between visits to the rheumatologist may be self-managed by the patient and underreported."

The mean age of study subjects was 55 years, their mean duration of disease was 6.3 years, and 71% were female. NOR-DMARD is an ongoing, longitudinal, observational study of patients initiating DMARD (disease-modifying antirheumatic drug) therapy. Of the 1,195 participants studied, 727 were taking methotrexate, 224 received other nonbiologic DMARD agents, 229 took a tumor necrosis factor inhibitor, and 15 were taking other biologic therapy.

Patients and clinicians used Delphi exercises (a survey process in which they identified the six most relevant domains for flare from among pain, function, swollen joints, tender joints, stiffness, participation, patient global assessment, self-management, and fatigue). Some of these identified domains are featured in the RA core set (often referred to as the American College of Rheumatology core set), but others – like stiffness, self-management, and participation – are not.

Dr. Lie explained how the investigators performed an additional analysis, defining flare by change in treatment, such as a step-up of DMARD or systemic corticosteroid therapy. This yielded 162 flare patients, only 35 of whom also were identified using their patient-centered working definition. The implication is that a flare definition based on patient report of disease worsening is truly distinct and warrants further study.

The research is ongoing. A meeting attendee suggested that Dr. Lie consider assessment of concomitant osteoarthritis in the future as well, to avoid any contribution to assessment of rheumatoid arthritis flare in the study. Further results of this study are in press in Annals of the Rheumatic Diseases.

Dr. Lie did not have any relevant financial disclosures.

A novel risk score for predicting serious infections in individual patients with rheumatoid arthritis who are treated with either tumor necrosis factor–alpha inhibitors or conventional disease-modifying antirheumatic drugs showed high agreement between observed and expected rates of serious infection, said Dr. Angela Zink at the annual European Congress of Rheumatology.

The score, known as the RABBIT risk score, is named for the German biologics register from which patients were enrolled. The risk score was previously evaluated in 5,044 patients enrolled in the RABBIT register between May 2001 and December 2006, and was shown to provide detailed information about the expected absolute risk of serious infection findings (Ann. Rheum. Dis. 2011;70:1914-20).

The new findings demonstrate the value of the score in a new population of patients not included in the previous analysis because they enrolled in the register after January 2009. Taken together, the two sets of data suggest that the score will serve as a useful tool with which rheumatologists can identify patients at increased risk of infection. By knowing the score, rheumatologists can avoid the use of treatment combinations that confer an increased risk for serious infection, said Dr. Zink of the German Rheumatism Research Center, Berlin.

"We showed that the risk of an individual patient at any point in time results from background risks such as age, comorbidity, or treatment history, and from risks that change over time, such as the activity of the disease, functional status, comedication with glucocorticoids, or treatment with TNF inhibitors or conventional DMARDs," Dr. Zink said, noting that multivariate methods were used to calculate the relative contributions of each of these factors. Dr. Zink presented the results for Dr. Anja Strangfeld, a colleague at the German Rheumatism Research Center.

For the analysis the investigators used data from 1,327 RA patients who were treated with TNF-alpha inhibitors and 1,276 RA patients treated with conventional DMARDs. The patients included in this analysis were enrolled in the RABBIT register at the start of their treatment with anti-TNF-alphas or DMARDs. The investigators used the RABBIT score to determine the serious infection risk, and they compared the observed serious infection rate with the expected rate in the total cohort and certain defined subgroups.

Agreement between the observed and expected rates of serious infection was high, as was agreement in subgroups of patients with a higher risk of infections. For example, the observed and expected rates of serious infection in those taking a TNF-alpha inhibitor were 3.2 and 3.0 serious infections per 100 person-years, respectively, and the observed and expected rates of serious infection in those taking a conventional DMARD were 1.3 and 1.5 serious infections per 100 person-years, respectively. Among those at high risk (based on the presence of one or more risk factors) who were taking a TNF-alpha inhibitor, the observed and expected rates were 5.2 and 4.3 serious infections per 100 person-years, respectively, and among those at high risk who were taking a conventional DMARD, the observed and expected rates were 1.7 and 1.9 serious infections per 100 person-years, respectively.

"We think that long-term observational studies of new treatments offer excellent opportunities to understand what happens during the treatment of real-life patients," Dr. Zink said of the value of biologics registers in general.

These data allow us to balance risks against each other, she added.

"For instance, an almost fivefold risk of serious infection was found in patients who had to be treated with dosages of glucocorticoids of 15 mg/day or above, compared to those with less than 7.5mg/day. TNF inhibition, which was associated with a 1.8-fold increased overall risk of infection, can lead to a decrease in risk if the disease activity is successfully suppressed, thereby allowing the glucocorticoid dose to be reduced," she explained.

The researchers did not disclose any conflicts of interest. This research was supported by a joint unconditional grant from Abbott, Amgen/Swedish Orphan Biovitrum, Bristol Myers Squibb, Essex/MSD, Pfizer, Roche, and UCB.

A novel risk score for predicting serious infections in individual patients with rheumatoid arthritis who are treated with either tumor necrosis factor–alpha inhibitors or conventional disease-modifying antirheumatic drugs showed high agreement between observed and expected rates of serious infection, said Dr. Angela Zink at the annual European Congress of Rheumatology.

The score, known as the RABBIT risk score, is named for the German biologics register from which patients were enrolled. The risk score was previously evaluated in 5,044 patients enrolled in the RABBIT register between May 2001 and December 2006, and was shown to provide detailed information about the expected absolute risk of serious infection findings (Ann. Rheum. Dis. 2011;70:1914-20).

The new findings demonstrate the value of the score in a new population of patients not included in the previous analysis because they enrolled in the register after January 2009. Taken together, the two sets of data suggest that the score will serve as a useful tool with which rheumatologists can identify patients at increased risk of infection. By knowing the score, rheumatologists can avoid the use of treatment combinations that confer an increased risk for serious infection, said Dr. Zink of the German Rheumatism Research Center, Berlin.

"We showed that the risk of an individual patient at any point in time results from background risks such as age, comorbidity, or treatment history, and from risks that change over time, such as the activity of the disease, functional status, comedication with glucocorticoids, or treatment with TNF inhibitors or conventional DMARDs," Dr. Zink said, noting that multivariate methods were used to calculate the relative contributions of each of these factors. Dr. Zink presented the results for Dr. Anja Strangfeld, a colleague at the German Rheumatism Research Center.

For the analysis the investigators used data from 1,327 RA patients who were treated with TNF-alpha inhibitors and 1,276 RA patients treated with conventional DMARDs. The patients included in this analysis were enrolled in the RABBIT register at the start of their treatment with anti-TNF-alphas or DMARDs. The investigators used the RABBIT score to determine the serious infection risk, and they compared the observed serious infection rate with the expected rate in the total cohort and certain defined subgroups.

Agreement between the observed and expected rates of serious infection was high, as was agreement in subgroups of patients with a higher risk of infections. For example, the observed and expected rates of serious infection in those taking a TNF-alpha inhibitor were 3.2 and 3.0 serious infections per 100 person-years, respectively, and the observed and expected rates of serious infection in those taking a conventional DMARD were 1.3 and 1.5 serious infections per 100 person-years, respectively. Among those at high risk (based on the presence of one or more risk factors) who were taking a TNF-alpha inhibitor, the observed and expected rates were 5.2 and 4.3 serious infections per 100 person-years, respectively, and among those at high risk who were taking a conventional DMARD, the observed and expected rates were 1.7 and 1.9 serious infections per 100 person-years, respectively.

"We think that long-term observational studies of new treatments offer excellent opportunities to understand what happens during the treatment of real-life patients," Dr. Zink said of the value of biologics registers in general.

These data allow us to balance risks against each other, she added.

"For instance, an almost fivefold risk of serious infection was found in patients who had to be treated with dosages of glucocorticoids of 15 mg/day or above, compared to those with less than 7.5mg/day. TNF inhibition, which was associated with a 1.8-fold increased overall risk of infection, can lead to a decrease in risk if the disease activity is successfully suppressed, thereby allowing the glucocorticoid dose to be reduced," she explained.

The researchers did not disclose any conflicts of interest. This research was supported by a joint unconditional grant from Abbott, Amgen/Swedish Orphan Biovitrum, Bristol Myers Squibb, Essex/MSD, Pfizer, Roche, and UCB.

A novel risk score for predicting serious infections in individual patients with rheumatoid arthritis who are treated with either tumor necrosis factor–alpha inhibitors or conventional disease-modifying antirheumatic drugs showed high agreement between observed and expected rates of serious infection, said Dr. Angela Zink at the annual European Congress of Rheumatology.

The score, known as the RABBIT risk score, is named for the German biologics register from which patients were enrolled. The risk score was previously evaluated in 5,044 patients enrolled in the RABBIT register between May 2001 and December 2006, and was shown to provide detailed information about the expected absolute risk of serious infection findings (Ann. Rheum. Dis. 2011;70:1914-20).

The new findings demonstrate the value of the score in a new population of patients not included in the previous analysis because they enrolled in the register after January 2009. Taken together, the two sets of data suggest that the score will serve as a useful tool with which rheumatologists can identify patients at increased risk of infection. By knowing the score, rheumatologists can avoid the use of treatment combinations that confer an increased risk for serious infection, said Dr. Zink of the German Rheumatism Research Center, Berlin.

"We showed that the risk of an individual patient at any point in time results from background risks such as age, comorbidity, or treatment history, and from risks that change over time, such as the activity of the disease, functional status, comedication with glucocorticoids, or treatment with TNF inhibitors or conventional DMARDs," Dr. Zink said, noting that multivariate methods were used to calculate the relative contributions of each of these factors. Dr. Zink presented the results for Dr. Anja Strangfeld, a colleague at the German Rheumatism Research Center.

For the analysis the investigators used data from 1,327 RA patients who were treated with TNF-alpha inhibitors and 1,276 RA patients treated with conventional DMARDs. The patients included in this analysis were enrolled in the RABBIT register at the start of their treatment with anti-TNF-alphas or DMARDs. The investigators used the RABBIT score to determine the serious infection risk, and they compared the observed serious infection rate with the expected rate in the total cohort and certain defined subgroups.

Agreement between the observed and expected rates of serious infection was high, as was agreement in subgroups of patients with a higher risk of infections. For example, the observed and expected rates of serious infection in those taking a TNF-alpha inhibitor were 3.2 and 3.0 serious infections per 100 person-years, respectively, and the observed and expected rates of serious infection in those taking a conventional DMARD were 1.3 and 1.5 serious infections per 100 person-years, respectively. Among those at high risk (based on the presence of one or more risk factors) who were taking a TNF-alpha inhibitor, the observed and expected rates were 5.2 and 4.3 serious infections per 100 person-years, respectively, and among those at high risk who were taking a conventional DMARD, the observed and expected rates were 1.7 and 1.9 serious infections per 100 person-years, respectively.

"We think that long-term observational studies of new treatments offer excellent opportunities to understand what happens during the treatment of real-life patients," Dr. Zink said of the value of biologics registers in general.

These data allow us to balance risks against each other, she added.

"For instance, an almost fivefold risk of serious infection was found in patients who had to be treated with dosages of glucocorticoids of 15 mg/day or above, compared to those with less than 7.5mg/day. TNF inhibition, which was associated with a 1.8-fold increased overall risk of infection, can lead to a decrease in risk if the disease activity is successfully suppressed, thereby allowing the glucocorticoid dose to be reduced," she explained.

The researchers did not disclose any conflicts of interest. This research was supported by a joint unconditional grant from Abbott, Amgen/Swedish Orphan Biovitrum, Bristol Myers Squibb, Essex/MSD, Pfizer, Roche, and UCB.

Early remission and sustained remission are associated with improved survival in patients with inflammatory polyarthritis, according to findings from the Norfolk Arthritis Register presented by Dr. Carlo Alberto Scirè at the annual European Congress of Rheumatology.

The findings provide further evidence of the importance of targeting remission, Dr. Scirè said in an interview.

"Several previous studies have demonstrated the influence of clinical remission in terms of reduction of joint damage and development of functional disability in patients with inflammatory polyarthritis, including rheumatoid arthritis. Given that rheumatoid arthritis also associates with increased mortality, we aimed to explore the relationship between clinical remission and mortality," said Dr. Scirè of the epidemiology unit of the Italian Society for Rheumatology, Milan, who is also currently a visiting scholar at the arthritis epidemiology unit of Manchester (England) University.

The Norfolk Arthritis Register, a primary care–based inception cohort of patients with inflammatory polyarthritis, provides a unique source of data with which to explore this relationship, he noted.

For the study, Dr. Scirè and his coinvestigators analyzed data from the more than 1,600 patients who were recruited in 1990-1994 and 2000-2004 and were followed for a median of 10 years. The investigators used three definitions of remission that varied in their strictness. More than a third of the patients met at least the most liberal definition of remission criteria at least once within the first 3 years. The strictest definition of remission allowed for the patient to have not a single swollen or tender joint in a 51 joint count exam. The least stringent allowed for a single swollen or tender joint in a 28-joint count exam, Dr. Scirè explained.

After the investigators adjusted for demographics, baseline disease activity, baseline disease severity, and cumulative treatment variables, 20% more of these patients survived compared with those who did not achieve remission within the first 3 years of follow-up.

The number of times patients achieved remission was also associated with a significant decrease in the risk of all-cause mortality, with a 10% decrease in risk per each additional time they achieved remission.

The greatest reduction in mortality risk was seen in those who achieved remission (as defined by the strictest standard) at 1 year after the first assessment, compared with those who did not achieve remission during the first 3 years. No similar association was found for patients who achieved remission after the first year, Dr. Scirè noted.

Registry patients included in the study were consecutive patients with early inflammatory polyarthritis. They were assessed at baseline through the 51 tender and swollen joint count, the Health Assessment Questionnaire, and blood testing. The joint counts were also assessed at the 1-, 2-, and 3-year follow-up.

Remission for this study was defined as the absence of clinically detectable joint inflammation.

"This study provides evidence of an association between the achievement of the absence of clinically detectable joint inflammation [used as an indicator of clinical remission] and decrease [in] mortality, supporting the relevance of targeting remission when treating rheumatoid arthritis in clinical practice," Dr. Scirè said.

Patients who met the strictest definition of remission seem to lengthen their survival by 2-3 years, according to Dr. Scirè. An audience member noted that the diagnosis of rheumatoid arthritis shortens life by about 7 years, so meeting a strict definition of remission within the first year after diagnosis comes close to halving that increased mortality burden.

Early remission and sustained remission are associated with improved survival in patients with inflammatory polyarthritis, according to findings from the Norfolk Arthritis Register presented by Dr. Carlo Alberto Scirè at the annual European Congress of Rheumatology.

The findings provide further evidence of the importance of targeting remission, Dr. Scirè said in an interview.

"Several previous studies have demonstrated the influence of clinical remission in terms of reduction of joint damage and development of functional disability in patients with inflammatory polyarthritis, including rheumatoid arthritis. Given that rheumatoid arthritis also associates with increased mortality, we aimed to explore the relationship between clinical remission and mortality," said Dr. Scirè of the epidemiology unit of the Italian Society for Rheumatology, Milan, who is also currently a visiting scholar at the arthritis epidemiology unit of Manchester (England) University.

The Norfolk Arthritis Register, a primary care–based inception cohort of patients with inflammatory polyarthritis, provides a unique source of data with which to explore this relationship, he noted.

For the study, Dr. Scirè and his coinvestigators analyzed data from the more than 1,600 patients who were recruited in 1990-1994 and 2000-2004 and were followed for a median of 10 years. The investigators used three definitions of remission that varied in their strictness. More than a third of the patients met at least the most liberal definition of remission criteria at least once within the first 3 years. The strictest definition of remission allowed for the patient to have not a single swollen or tender joint in a 51 joint count exam. The least stringent allowed for a single swollen or tender joint in a 28-joint count exam, Dr. Scirè explained.

After the investigators adjusted for demographics, baseline disease activity, baseline disease severity, and cumulative treatment variables, 20% more of these patients survived compared with those who did not achieve remission within the first 3 years of follow-up.

The number of times patients achieved remission was also associated with a significant decrease in the risk of all-cause mortality, with a 10% decrease in risk per each additional time they achieved remission.

The greatest reduction in mortality risk was seen in those who achieved remission (as defined by the strictest standard) at 1 year after the first assessment, compared with those who did not achieve remission during the first 3 years. No similar association was found for patients who achieved remission after the first year, Dr. Scirè noted.

Registry patients included in the study were consecutive patients with early inflammatory polyarthritis. They were assessed at baseline through the 51 tender and swollen joint count, the Health Assessment Questionnaire, and blood testing. The joint counts were also assessed at the 1-, 2-, and 3-year follow-up.

Remission for this study was defined as the absence of clinically detectable joint inflammation.

"This study provides evidence of an association between the achievement of the absence of clinically detectable joint inflammation [used as an indicator of clinical remission] and decrease [in] mortality, supporting the relevance of targeting remission when treating rheumatoid arthritis in clinical practice," Dr. Scirè said.

Patients who met the strictest definition of remission seem to lengthen their survival by 2-3 years, according to Dr. Scirè. An audience member noted that the diagnosis of rheumatoid arthritis shortens life by about 7 years, so meeting a strict definition of remission within the first year after diagnosis comes close to halving that increased mortality burden.

Early remission and sustained remission are associated with improved survival in patients with inflammatory polyarthritis, according to findings from the Norfolk Arthritis Register presented by Dr. Carlo Alberto Scirè at the annual European Congress of Rheumatology.

The findings provide further evidence of the importance of targeting remission, Dr. Scirè said in an interview.

"Several previous studies have demonstrated the influence of clinical remission in terms of reduction of joint damage and development of functional disability in patients with inflammatory polyarthritis, including rheumatoid arthritis. Given that rheumatoid arthritis also associates with increased mortality, we aimed to explore the relationship between clinical remission and mortality," said Dr. Scirè of the epidemiology unit of the Italian Society for Rheumatology, Milan, who is also currently a visiting scholar at the arthritis epidemiology unit of Manchester (England) University.

The Norfolk Arthritis Register, a primary care–based inception cohort of patients with inflammatory polyarthritis, provides a unique source of data with which to explore this relationship, he noted.

For the study, Dr. Scirè and his coinvestigators analyzed data from the more than 1,600 patients who were recruited in 1990-1994 and 2000-2004 and were followed for a median of 10 years. The investigators used three definitions of remission that varied in their strictness. More than a third of the patients met at least the most liberal definition of remission criteria at least once within the first 3 years. The strictest definition of remission allowed for the patient to have not a single swollen or tender joint in a 51 joint count exam. The least stringent allowed for a single swollen or tender joint in a 28-joint count exam, Dr. Scirè explained.

After the investigators adjusted for demographics, baseline disease activity, baseline disease severity, and cumulative treatment variables, 20% more of these patients survived compared with those who did not achieve remission within the first 3 years of follow-up.

The number of times patients achieved remission was also associated with a significant decrease in the risk of all-cause mortality, with a 10% decrease in risk per each additional time they achieved remission.

The greatest reduction in mortality risk was seen in those who achieved remission (as defined by the strictest standard) at 1 year after the first assessment, compared with those who did not achieve remission during the first 3 years. No similar association was found for patients who achieved remission after the first year, Dr. Scirè noted.

Registry patients included in the study were consecutive patients with early inflammatory polyarthritis. They were assessed at baseline through the 51 tender and swollen joint count, the Health Assessment Questionnaire, and blood testing. The joint counts were also assessed at the 1-, 2-, and 3-year follow-up.

Remission for this study was defined as the absence of clinically detectable joint inflammation.

"This study provides evidence of an association between the achievement of the absence of clinically detectable joint inflammation [used as an indicator of clinical remission] and decrease [in] mortality, supporting the relevance of targeting remission when treating rheumatoid arthritis in clinical practice," Dr. Scirè said.

Patients who met the strictest definition of remission seem to lengthen their survival by 2-3 years, according to Dr. Scirè. An audience member noted that the diagnosis of rheumatoid arthritis shortens life by about 7 years, so meeting a strict definition of remission within the first year after diagnosis comes close to halving that increased mortality burden.

The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis appear to be more sensitive than the 1987 criteria for the early identification of RA patients, but the two sets of criteria may identify different patient groups, judging from findings presented by Jenny Humphreys, Ph.D.

Looking at 260 patients enrolled in the Norfolk Arthritis Register, a primary care–based inception cohort, who presented between 1990 and 1995 with early inflammatory arthritis symptoms, the investigators found that the 2010 criteria identified as many patients with early RA at baseline as did the 1987 criteria over 5 years, Dr. Humphreys said in an interview at the Annual European Congress of Rheumatology meeting. All subjects were 16 years of age or older at the time they enrolled in the Norfolk Arthritis Register.

Specifically, the incidence rates for RA according to the 2010 criteria were 53.9 cases per 100,000 population for women at baseline and 24.5 cases per 100,000 population for men at baseline, which were similar to the cumulative 5-year incidence rates of 55.7 cases for women and 26.5 cases for men according to the 1987 criteria, said Dr. Humphreys, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester (England).

This suggests that "the 2010 criteria are allowing us to identify these patients earlier on, which is useful," she said, noting that the 1987 criteria identified only 44 cases/100,000 population for women with RA at baseline and only 19 cases/100,000 population for men at baseline.

This is the first study to estimate the incidence of RA using the 2010 ACR/EULAR classification criteria for RA, she noted.

"What we have shown is that the incidence of RA using the 2010 criteria is greater when patients first present to health care services," compared with the previous criteria from 1987, Dr. Humphreys said.

However, although the total numbers of patients identified at baseline by the 2010 criteria, and over 5 years by the 1987 criteria, were similar, those identified "were not exactly the same group of patients," she noted.

For example, 4% of patients who satisfied the 1987 criteria cumulatively over 5 years never satisfied the new criteria, and 14% who satisfied the new criteria never satisfied the 1987 criteria. The patients who satisfied the earlier criteria but not the new criteria had more hand joint involvement, symmetrical arthritis, and morning stiffness than did those who satisfied both sets of criteria or just the 2010 criteria.

"This means we need to explore in detail the long-term outcomes in those patients who only ever meet one criteria set," Dr. Humphreys said.

The incidence of a disease is always important in health economics because it gives an idea of the frequency of its occurrence in the population, and resources may be allocated based on this. In addition, it has been suggested that the 2010 criteria could be used as eligibility criteria for certain interventions in RA patients, although this has not been validated and is not currently recommended. "Our data suggest that if that were the case, similar amounts of resources would be required but they may need to be made available earlier, when patients first present with symptoms," she said.

Dr. Humphreys reported that she had no financial conflicts of interest that were relevant to this research.

The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis appear to be more sensitive than the 1987 criteria for the early identification of RA patients, but the two sets of criteria may identify different patient groups, judging from findings presented by Jenny Humphreys, Ph.D.

Looking at 260 patients enrolled in the Norfolk Arthritis Register, a primary care–based inception cohort, who presented between 1990 and 1995 with early inflammatory arthritis symptoms, the investigators found that the 2010 criteria identified as many patients with early RA at baseline as did the 1987 criteria over 5 years, Dr. Humphreys said in an interview at the Annual European Congress of Rheumatology meeting. All subjects were 16 years of age or older at the time they enrolled in the Norfolk Arthritis Register.

Specifically, the incidence rates for RA according to the 2010 criteria were 53.9 cases per 100,000 population for women at baseline and 24.5 cases per 100,000 population for men at baseline, which were similar to the cumulative 5-year incidence rates of 55.7 cases for women and 26.5 cases for men according to the 1987 criteria, said Dr. Humphreys, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester (England).

This suggests that "the 2010 criteria are allowing us to identify these patients earlier on, which is useful," she said, noting that the 1987 criteria identified only 44 cases/100,000 population for women with RA at baseline and only 19 cases/100,000 population for men at baseline.

This is the first study to estimate the incidence of RA using the 2010 ACR/EULAR classification criteria for RA, she noted.

"What we have shown is that the incidence of RA using the 2010 criteria is greater when patients first present to health care services," compared with the previous criteria from 1987, Dr. Humphreys said.

However, although the total numbers of patients identified at baseline by the 2010 criteria, and over 5 years by the 1987 criteria, were similar, those identified "were not exactly the same group of patients," she noted.

For example, 4% of patients who satisfied the 1987 criteria cumulatively over 5 years never satisfied the new criteria, and 14% who satisfied the new criteria never satisfied the 1987 criteria. The patients who satisfied the earlier criteria but not the new criteria had more hand joint involvement, symmetrical arthritis, and morning stiffness than did those who satisfied both sets of criteria or just the 2010 criteria.

"This means we need to explore in detail the long-term outcomes in those patients who only ever meet one criteria set," Dr. Humphreys said.

The incidence of a disease is always important in health economics because it gives an idea of the frequency of its occurrence in the population, and resources may be allocated based on this. In addition, it has been suggested that the 2010 criteria could be used as eligibility criteria for certain interventions in RA patients, although this has not been validated and is not currently recommended. "Our data suggest that if that were the case, similar amounts of resources would be required but they may need to be made available earlier, when patients first present with symptoms," she said.

Dr. Humphreys reported that she had no financial conflicts of interest that were relevant to this research.

The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis appear to be more sensitive than the 1987 criteria for the early identification of RA patients, but the two sets of criteria may identify different patient groups, judging from findings presented by Jenny Humphreys, Ph.D.

Looking at 260 patients enrolled in the Norfolk Arthritis Register, a primary care–based inception cohort, who presented between 1990 and 1995 with early inflammatory arthritis symptoms, the investigators found that the 2010 criteria identified as many patients with early RA at baseline as did the 1987 criteria over 5 years, Dr. Humphreys said in an interview at the Annual European Congress of Rheumatology meeting. All subjects were 16 years of age or older at the time they enrolled in the Norfolk Arthritis Register.

Specifically, the incidence rates for RA according to the 2010 criteria were 53.9 cases per 100,000 population for women at baseline and 24.5 cases per 100,000 population for men at baseline, which were similar to the cumulative 5-year incidence rates of 55.7 cases for women and 26.5 cases for men according to the 1987 criteria, said Dr. Humphreys, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester (England).

This suggests that "the 2010 criteria are allowing us to identify these patients earlier on, which is useful," she said, noting that the 1987 criteria identified only 44 cases/100,000 population for women with RA at baseline and only 19 cases/100,000 population for men at baseline.

This is the first study to estimate the incidence of RA using the 2010 ACR/EULAR classification criteria for RA, she noted.

"What we have shown is that the incidence of RA using the 2010 criteria is greater when patients first present to health care services," compared with the previous criteria from 1987, Dr. Humphreys said.

However, although the total numbers of patients identified at baseline by the 2010 criteria, and over 5 years by the 1987 criteria, were similar, those identified "were not exactly the same group of patients," she noted.

For example, 4% of patients who satisfied the 1987 criteria cumulatively over 5 years never satisfied the new criteria, and 14% who satisfied the new criteria never satisfied the 1987 criteria. The patients who satisfied the earlier criteria but not the new criteria had more hand joint involvement, symmetrical arthritis, and morning stiffness than did those who satisfied both sets of criteria or just the 2010 criteria.

"This means we need to explore in detail the long-term outcomes in those patients who only ever meet one criteria set," Dr. Humphreys said.

The incidence of a disease is always important in health economics because it gives an idea of the frequency of its occurrence in the population, and resources may be allocated based on this. In addition, it has been suggested that the 2010 criteria could be used as eligibility criteria for certain interventions in RA patients, although this has not been validated and is not currently recommended. "Our data suggest that if that were the case, similar amounts of resources would be required but they may need to be made available earlier, when patients first present with symptoms," she said.

Dr. Humphreys reported that she had no financial conflicts of interest that were relevant to this research.

A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.

"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."

"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."

The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.

To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.

The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.

"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.

Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.

The recommendations – in three different categories – are as follows:

Education and prevention

• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.

• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.

• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.

• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.

• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.

Dosing/risk-benefit

• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.

• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.

• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.

Monitoring

• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.

The recommendation rejected by the task force is as follows:

• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.

Dr. Duru reported that she has no relevant conflicts of interest.

A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.

"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."

"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."

The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.

To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.

The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.

"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.

Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.

The recommendations – in three different categories – are as follows:

Education and prevention

• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.

• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.

• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.

• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.

• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.

Dosing/risk-benefit

• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.

• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.

• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.

Monitoring

• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.

The recommendation rejected by the task force is as follows:

• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.

Dr. Duru reported that she has no relevant conflicts of interest.

A multidisciplinary EULAR task force has developed for the first time recommendations for the management of medium- to high-dose systemic glucocorticoid therapy in rheumatic diseases at the annual European Congress of Rheumatology.

"High doses are very important because systemic glucocorticoids work rapidly and are most effective, but there is very little known about adverse events and incidence," said Dr. Nurten Duru said in an interview. "There are many studies; however, the adverse events are not systematically assessed. The studies have not focused on the adverse events; they have involved investigation of efficacy."

"We expect to see adverse events at high doses but the question is how to handle these, and how to take the co-morbidities into consideration. This is difficult without data. The best we have is expert opinion and they advise vigilance for these adverse events."

The recommendations focus on patient education and informing general practitioners, preventive measures for osteoporosis, optimal glucocorticoid (GC) starting dosages, risk-benefit ratio of GC treatment, GC sparing therapy, screening for co morbidity, and monitoring for adverse events, according to Dr. Duru, a rheumatologist at University Medical Center Utrecht, the Netherlands.

To develop the recommendations the task force conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library, and the strength of recommendations was given according to available evidence, clinical expertise and patient preference. However, "robust evidence was often lacking and items in need for further research were defined," the task force noted.

The task force comprised eight rheumatologists, one endocrinologist, one rheumatologist/epidemiologist, four patients, and two research fellows from seven European countries. "Each participant contributed 10 propositions describing key clinical points concerning the safe use of medium to high dose GCs. The final recommendations were developed using a Delphi consensus approach and the wording was improved by a native speaker," according to the task force.

"In this EULAR task force patients participated. The most important issue from the patient point of view was their concern with side effects such as alopecia," she said.

Dr. Duru said the next steps maybe developing a patient-friendly version of the recommendations in different languages, or a website where physicians could search for information about glucocorticoids.

The recommendations – in three different categories – are as follows:

Education and prevention

• Explain to patients (and their family and/or caregivers, including general practitioners) the aim of medium-/high-dose GC treatment and the potential risks associated with such therapy.

• Discuss measures to mitigate such risks, including diet, regular exercise, and awareness of wounds.

• Dispense appropriate preventive/therapeutic interventions to patients with or at risk of GC-induced osteoporosis.

• Present appropriate, practical advice to patients and the patients’ treatment teams on how to manage with GC-induced hypothalamic-pituitary-adrenal axis suppression.

• Provide an accessible resource to promote best practice in the use of medium/high dose GCs to general practitioners.

Dosing/risk-benefit

• Consider comorbidities that might predispose patients to adverse effects before starting them on medium-/high dose GC treatment; these include diabetes, glucose intolerance, cardiovascular disease, peptic ulcer disease, chronic infections, severe immunosuppression, (risk factors of) glaucoma, and osteoporosis. Patients with these comorbidities require especially tight control of dosages to manage the risk/benefit ratio.

• Select the appropriate starting dose as the (expected) minimum required to achieve therapeutic response.

• Keep the requirement for continuing on GC treatment under constant review and titrate the dose against therapeutic response and any developing adverse effects.

Monitoring

• Regularly monitor all patients for frequent, clinically significant adverse effects. The minimum set of items to monitor includes diabetes, hypertension, dyslipidemia, weight gain, edema, osteoporosis, (hidden) infections, osteonecrosis, myopathy, eye problems, skin problems, and neuropsychological adverse effects.

The recommendation rejected by the task force is as follows:

• Actively consider GC sparing therapy if long-term medium-/high-dose GC therapy is anticipated to be necessary.

Dr. Duru reported that she has no relevant conflicts of interest.