EULAR (European League Against Rheumatism): 2012 Congress

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 – A 6-month course of rosuvastatin (Crestor) significantly lessened endothelial dysfunction and lowered levels of C-reactive protein in patients with systemic sclerosis, judging from findings from a new study presented at the annual European Congress of Rheumatology.

Dr. Gabriella Szucs of the department of rheumatology, University of Debrecen, Hungary, presented results from the first study of rosuvastatin therapy in systemic sclerosis (SSc), measuring the extent of endothelial dysfunction and response to the drug in the small and large vessels of these patients.

The most significant results were seen in flow-mediated dilatation (FMD), which improved from 2.2% plus or minus 3.1% to 5.7% plus or minus 3.8% (P = .0033) over the 6 months of rosuvastatin therapy. A normal level of FMD would be 8%.

The Hungarian researcher said she and her colleagues wanted to find out whether statin therapy improved the endothelial and macrovascular function as well as arterial stiffness. "These patients had systemic sclerosis with continuous progression for which we don’t even have basic therapy or so-called disease-modifying therapy. We need to try everything to see if something works or not," said Dr. Szucs, the principal investigator.

"Endothelial dysfunction is one of the first steps in the pathogenesis of the disease. If we can improve this step, it is possible that we can slow disease progression, but if this is allowed to worsen then vascular complications lead to clinical symptoms."

All 28 patients who entered the case series study had SSc, according to American College of Rheumatology criteria. The majority (25/28) were female, and average disease duration was just over 13 years. The limited form of SSc, which is most common in females, was present in 21 patients, and 7 had the cutaneous form. Patients included had not received any statin medication for 6 months prior to the study. All patients received 20 mg of rosuvastatin daily for the 6 months of the case-series study.

Other therapies used by patients, and on which they were stable at entry to the study, included ARB/ACE inhibitors (75%), calcium channel blockers (57%), and pentoxifylline (82%).

Vascular and laboratory parameters were checked both before and after rosuvastatin therapy, including triglycerides, total and low-density lipoprotein (LDL) cholesterol, and C-reactive protein (CRP) levels.

Notably, brachial artery flow-mediated dilatation significantly improved in 23 of the total of 28 patients (82%). "For stiffness in the larger arteries [pulse-wave velocity of the aorto-femoral and carotid-femoral] we didn’t see any changes but this might vary if treatment continues for longer. We intend to follow these patients up at 12 months and thereafter."

She added that CRP levels were also shown to improve. CRP levels dropped from 5.1 plus or minus 5.2 mg/L before treatment to 3.4 plus or minus 2.7 mg/L (P = .01) after 6 months. "They are almost in the normal range, but it is better for the patient to have a lower CRP because later cardiovascular morbidity and mortality can decrease."

As expected, LDL levels decreased over the 6 months from 3.0 plus or minus 1.3 mmol/L to 2.2 plus or minus 1.0 mmol/L (P = .005), and mean triglyceride levels dropped from 1.7 plus or minus 0.97 mmol/L to 1.3 plus or minus 0.46 mmol/L (P = .0004).

No difference was seen between the limited form or the diffuse cutaneous form, reported Dr. Szucs.

"Systemic sclerosis is basically a vascular disease and rosuvastatin may improve endothelial dysfunction, correct dyslipidemia, and decrease CRP levels," said Dr. Szucs. "These results suggest that statins should be used together with more conventional vasodilator therapy throughout the disease course in order to protect from micro- and macrovascular damage and complications in scleroderma."

Dr. Szucs has declared no relevant conflicts of interest.

BERLIN – A 6-month course of rosuvastatin (Crestor) significantly lessened endothelial dysfunction and lowered levels of C-reactive protein in patients with systemic sclerosis, judging from findings from a new study presented at the annual European Congress of Rheumatology.

Dr. Gabriella Szucs of the department of rheumatology, University of Debrecen, Hungary, presented results from the first study of rosuvastatin therapy in systemic sclerosis (SSc), measuring the extent of endothelial dysfunction and response to the drug in the small and large vessels of these patients.

The most significant results were seen in flow-mediated dilatation (FMD), which improved from 2.2% plus or minus 3.1% to 5.7% plus or minus 3.8% (P = .0033) over the 6 months of rosuvastatin therapy. A normal level of FMD would be 8%.

The Hungarian researcher said she and her colleagues wanted to find out whether statin therapy improved the endothelial and macrovascular function as well as arterial stiffness. "These patients had systemic sclerosis with continuous progression for which we don’t even have basic therapy or so-called disease-modifying therapy. We need to try everything to see if something works or not," said Dr. Szucs, the principal investigator.

"Endothelial dysfunction is one of the first steps in the pathogenesis of the disease. If we can improve this step, it is possible that we can slow disease progression, but if this is allowed to worsen then vascular complications lead to clinical symptoms."

All 28 patients who entered the case series study had SSc, according to American College of Rheumatology criteria. The majority (25/28) were female, and average disease duration was just over 13 years. The limited form of SSc, which is most common in females, was present in 21 patients, and 7 had the cutaneous form. Patients included had not received any statin medication for 6 months prior to the study. All patients received 20 mg of rosuvastatin daily for the 6 months of the case-series study.

Other therapies used by patients, and on which they were stable at entry to the study, included ARB/ACE inhibitors (75%), calcium channel blockers (57%), and pentoxifylline (82%).

Vascular and laboratory parameters were checked both before and after rosuvastatin therapy, including triglycerides, total and low-density lipoprotein (LDL) cholesterol, and C-reactive protein (CRP) levels.

Notably, brachial artery flow-mediated dilatation significantly improved in 23 of the total of 28 patients (82%). "For stiffness in the larger arteries [pulse-wave velocity of the aorto-femoral and carotid-femoral] we didn’t see any changes but this might vary if treatment continues for longer. We intend to follow these patients up at 12 months and thereafter."

She added that CRP levels were also shown to improve. CRP levels dropped from 5.1 plus or minus 5.2 mg/L before treatment to 3.4 plus or minus 2.7 mg/L (P = .01) after 6 months. "They are almost in the normal range, but it is better for the patient to have a lower CRP because later cardiovascular morbidity and mortality can decrease."

As expected, LDL levels decreased over the 6 months from 3.0 plus or minus 1.3 mmol/L to 2.2 plus or minus 1.0 mmol/L (P = .005), and mean triglyceride levels dropped from 1.7 plus or minus 0.97 mmol/L to 1.3 plus or minus 0.46 mmol/L (P = .0004).

No difference was seen between the limited form or the diffuse cutaneous form, reported Dr. Szucs.

"Systemic sclerosis is basically a vascular disease and rosuvastatin may improve endothelial dysfunction, correct dyslipidemia, and decrease CRP levels," said Dr. Szucs. "These results suggest that statins should be used together with more conventional vasodilator therapy throughout the disease course in order to protect from micro- and macrovascular damage and complications in scleroderma."

Dr. Szucs has declared no relevant conflicts of interest.

BERLIN – A 6-month course of rosuvastatin (Crestor) significantly lessened endothelial dysfunction and lowered levels of C-reactive protein in patients with systemic sclerosis, judging from findings from a new study presented at the annual European Congress of Rheumatology.

Dr. Gabriella Szucs of the department of rheumatology, University of Debrecen, Hungary, presented results from the first study of rosuvastatin therapy in systemic sclerosis (SSc), measuring the extent of endothelial dysfunction and response to the drug in the small and large vessels of these patients.

The most significant results were seen in flow-mediated dilatation (FMD), which improved from 2.2% plus or minus 3.1% to 5.7% plus or minus 3.8% (P = .0033) over the 6 months of rosuvastatin therapy. A normal level of FMD would be 8%.

The Hungarian researcher said she and her colleagues wanted to find out whether statin therapy improved the endothelial and macrovascular function as well as arterial stiffness. "These patients had systemic sclerosis with continuous progression for which we don’t even have basic therapy or so-called disease-modifying therapy. We need to try everything to see if something works or not," said Dr. Szucs, the principal investigator.

"Endothelial dysfunction is one of the first steps in the pathogenesis of the disease. If we can improve this step, it is possible that we can slow disease progression, but if this is allowed to worsen then vascular complications lead to clinical symptoms."

All 28 patients who entered the case series study had SSc, according to American College of Rheumatology criteria. The majority (25/28) were female, and average disease duration was just over 13 years. The limited form of SSc, which is most common in females, was present in 21 patients, and 7 had the cutaneous form. Patients included had not received any statin medication for 6 months prior to the study. All patients received 20 mg of rosuvastatin daily for the 6 months of the case-series study.

Other therapies used by patients, and on which they were stable at entry to the study, included ARB/ACE inhibitors (75%), calcium channel blockers (57%), and pentoxifylline (82%).

Vascular and laboratory parameters were checked both before and after rosuvastatin therapy, including triglycerides, total and low-density lipoprotein (LDL) cholesterol, and C-reactive protein (CRP) levels.

Notably, brachial artery flow-mediated dilatation significantly improved in 23 of the total of 28 patients (82%). "For stiffness in the larger arteries [pulse-wave velocity of the aorto-femoral and carotid-femoral] we didn’t see any changes but this might vary if treatment continues for longer. We intend to follow these patients up at 12 months and thereafter."

She added that CRP levels were also shown to improve. CRP levels dropped from 5.1 plus or minus 5.2 mg/L before treatment to 3.4 plus or minus 2.7 mg/L (P = .01) after 6 months. "They are almost in the normal range, but it is better for the patient to have a lower CRP because later cardiovascular morbidity and mortality can decrease."

As expected, LDL levels decreased over the 6 months from 3.0 plus or minus 1.3 mmol/L to 2.2 plus or minus 1.0 mmol/L (P = .005), and mean triglyceride levels dropped from 1.7 plus or minus 0.97 mmol/L to 1.3 plus or minus 0.46 mmol/L (P = .0004).

No difference was seen between the limited form or the diffuse cutaneous form, reported Dr. Szucs.

"Systemic sclerosis is basically a vascular disease and rosuvastatin may improve endothelial dysfunction, correct dyslipidemia, and decrease CRP levels," said Dr. Szucs. "These results suggest that statins should be used together with more conventional vasodilator therapy throughout the disease course in order to protect from micro- and macrovascular damage and complications in scleroderma."

Dr. Szucs has declared no relevant conflicts of interest.

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.

Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

Ustekinumab at 45-mg and 90-mg doses significantly improved arthritis symptoms, physical function, and inflammation in adults with psoriatic arthritis, compared with placebo, after 24 weeks of treatment, according to findings presented by Dr. Iain B. McInnes at the annual European Congress of Rheumatology.

These findings come from the PSUMMIT I study, a multicenter, randomized trial of 615 patients. Participants were patients whose psoriatic arthritis (PsA) remained persistent, despite treatment with NSAIDS or disease-modifying antirheumatic drugs (DMARDs). They were randomized to 45 mg of ustekinumab, 90 mg of ustekinumab, or a placebo. Patients who had been treated with anti–tumor necrosis factor (anti-TNF) agents were excluded from the study.

After 24 weeks, approximately half of the patients in the 45 mg–dose (42%) and 90 mg–dose (50%) groups achieved an ACR 20 response (that is, a 20% improvement based on certain parameters specified by the American College of Rheumatology); the percentages for both groups were significantly greater than that of the placebo group (23%).

"These findings are in line with our expectations from the original phase II trial published a short number of years ago and with the success already enjoyed in using this medicine in treating the skin component of the psoriasis/psoriatic arthritis spectrum," said Dr. McInnes, director of the Institute for Infection, Inflammation, and Immunity at the University of Glascow (Scotland). The findings are also gratifying, he added. "There has been some evidence elsewhere to suggest that the cytokines that are targeted by ustekinumab might be of importance in psoriasis and psoriatic arthritis pathogenesis – these clinical data are compatible with those ideas," he noted.

Significantly more patients in both ustekinumab groups achieved ACR 50 and ACR 70 responses, compared with the placebo patients. In addition, ustekinumab patients had clinically meaningful changes from baseline Health Assessment Questionnaire Disability Index scores (defined as a change greater than or equal to 0.3), compared with placebo patients. Approximately twice as many patients in the two treatment groups demonstrated this change, compared with the placebo patients (48% vs. 28%, respectively).

The median change in enthesitis scores were 43% in the 45-mg ustekinumab group and 50% in the 90-mg ustekinumab group, compared with no change in the placebo group.

So far, no substantial differences in adverse events between the treatment and placebo groups have emerged, Dr. McInnes said in an interview. However, "this is a small trial – in comparison to the larger phase III and postmarketing datasets for this agent in the psoriasis field – and as such we need to be conservative in our interpretation of adverse events," he emphasized. "Continued vigilance will be the key here, and follow-up is ongoing," he said.

If the findings are confirmed in other studies, "we may be able to offer this agent to provide a new mode of action for the treatment of psoriatic arthritis, a disease for which we currently have too few options available," said Dr. McInnes. However, "it is too early to determine at which stage in the patient journey such use would be optimally employed," he said.

"It seems self-evident that use of ustekinumab would be after conventional drugs have been tried, and then, most likely it would be used after a TNF inhibitor because that has been the order of discovery. This reflects the RA treatment paradigm.

"But this might not be the best course; in fact, we might get similar results with different modes of action. So without head-to-head data we would make our decision based on the extent of safety data available. There is considerable safety evidence for ustekinumab in the skin literature; however, right now there is a challenge to work out where this drug will be used if it is marketed" said Dr. McInnes.

Approximately half of the patients were using methotrexate at baseline, but this did not impact the effect of ustekinumab vs. placebo.

Dr. McInnes reported financial support from Janssen Research and Development.

Up to 13% of one cohort of adults with cystic fibrosis were affected by musculoskeletal complications, judging from data presented at the annual European Congress of Rheumatology by Dr. Ali Jawad of the Royal London Hospital and London Chest Hospital.

Because people with cystic fibrosis (CF) are living into adulthood these days, it has become clear that the same bone and joint manifestations of CF that are well known to the physicians who take care of them continue to be an issue for these patients in adulthood. But these bone manifestations have received very little attention in adults, Dr. Jawad said in an interview. Unless these problems are diagnosed early, they are likely to become disabling and interfere with CF treatment, he added.

"From our perspective, it’s a new type of disease involvement. We don’t seem to see the episodic or the hypertrophic osteoarthropathy. Is this because there is now better treatment for these patients? Most of the series reported were over the last decade. To summarize: Unlike other cases, we had no cases of large-joint episodic arthritis or hypertrophic osteoarthropathy; instead, our patients showed a polyarthritis with an age of onset of 25 in females and 38 in men. In addition to NSAIDs, a lot of these patients require DMARDs [disease-modifying antirheumatic drugs], and the important thing is that these patients need recognition because they depend on their mobility and exercise for chest clearance every day as the central component of the treatment of cystic fibrosis."

The study involved 143 adults with cystic fibrosis who attended the quarterly musculoskeletal clinic at the hospital’s CF unit.

With his coinvestigators, Dr. Jawad found that more than 13% of CF patients (aged 16 and older) in the cohort were affected by musculoskeletal complications. The age of onset was lower for female patients than males.

In the cohort, 7% of all patients were seen to have CF-related arthropathy (CFA), which manifests itself in recurrent episodes of swelling and stiffness in the large joints. In all cases, CFA took the form of polyarthralgia. Reports of previous research by other investigators have shown that CFA is a relatively infrequent complication, occurring in 2%-8.5% of the CF population.

Other musculoskeletal diseases seen in the cohort included spondyloarthritis, chondromalacia patellae, vitamin D deficiency, back pain, and rotator cuff tendinopathy. One patient had erosive disease on ultrasound examination, but that condition could not be confirmed by x-ray. None was seen to have hypertrophic osteoarthropathy, which is characterized by abnormal proliferation of the skin and bone tissue at the distal parts of the extremities.

"Our CF service is multidisciplinary, and includes practitioners from other disciplines such as hepatology, endocrinology, and rheumatology, along with specialist nurses, physiotherapists, and a nutritionist," Dr. Jawad said. Because most of the patients in the service receive nutritional advice, he added, vitamin D deficiency was rare.

Patients are customarily started on NSAIDs and, if these prove insufficient, are moved on to DMARDs. "Patients’ [responses] to DMARDs vary," Dr. Jawad said. "We initially start with sulfasalazine and/or hydroxychloroquine. If there is no response, we add or replace one of these with methotrexate. We have one patient on methotrexate for whom we are now considering a tumor necrosis factor inhibitor such as etanercept."

For patients with CF-related arthropathy and other complications, "early diagnosis is essential," Dr. Jawad said, because joint pain, swelling, and limitation of movement may become disabling and interfere with exercise and chest clearance, all of which are essential components of the treatment schedule for CF.

Although NSAIDs usually control symptoms, half of the patients needed DMARDs as well.

Early diagnosis and appropriate management are especially important for CF patients, because joint pain, swelling, and limitation of movement may become disabling and interfere with mobility, exercise, and clearing the airway of thick mucus, all essential components of CF daily treatment.

Up to 13% of one cohort of adults with cystic fibrosis were affected by musculoskeletal complications, judging from data presented at the annual European Congress of Rheumatology by Dr. Ali Jawad of the Royal London Hospital and London Chest Hospital.

Because people with cystic fibrosis (CF) are living into adulthood these days, it has become clear that the same bone and joint manifestations of CF that are well known to the physicians who take care of them continue to be an issue for these patients in adulthood. But these bone manifestations have received very little attention in adults, Dr. Jawad said in an interview. Unless these problems are diagnosed early, they are likely to become disabling and interfere with CF treatment, he added.

"From our perspective, it’s a new type of disease involvement. We don’t seem to see the episodic or the hypertrophic osteoarthropathy. Is this because there is now better treatment for these patients? Most of the series reported were over the last decade. To summarize: Unlike other cases, we had no cases of large-joint episodic arthritis or hypertrophic osteoarthropathy; instead, our patients showed a polyarthritis with an age of onset of 25 in females and 38 in men. In addition to NSAIDs, a lot of these patients require DMARDs [disease-modifying antirheumatic drugs], and the important thing is that these patients need recognition because they depend on their mobility and exercise for chest clearance every day as the central component of the treatment of cystic fibrosis."

The study involved 143 adults with cystic fibrosis who attended the quarterly musculoskeletal clinic at the hospital’s CF unit.

With his coinvestigators, Dr. Jawad found that more than 13% of CF patients (aged 16 and older) in the cohort were affected by musculoskeletal complications. The age of onset was lower for female patients than males.

In the cohort, 7% of all patients were seen to have CF-related arthropathy (CFA), which manifests itself in recurrent episodes of swelling and stiffness in the large joints. In all cases, CFA took the form of polyarthralgia. Reports of previous research by other investigators have shown that CFA is a relatively infrequent complication, occurring in 2%-8.5% of the CF population.

Other musculoskeletal diseases seen in the cohort included spondyloarthritis, chondromalacia patellae, vitamin D deficiency, back pain, and rotator cuff tendinopathy. One patient had erosive disease on ultrasound examination, but that condition could not be confirmed by x-ray. None was seen to have hypertrophic osteoarthropathy, which is characterized by abnormal proliferation of the skin and bone tissue at the distal parts of the extremities.

"Our CF service is multidisciplinary, and includes practitioners from other disciplines such as hepatology, endocrinology, and rheumatology, along with specialist nurses, physiotherapists, and a nutritionist," Dr. Jawad said. Because most of the patients in the service receive nutritional advice, he added, vitamin D deficiency was rare.

Patients are customarily started on NSAIDs and, if these prove insufficient, are moved on to DMARDs. "Patients’ [responses] to DMARDs vary," Dr. Jawad said. "We initially start with sulfasalazine and/or hydroxychloroquine. If there is no response, we add or replace one of these with methotrexate. We have one patient on methotrexate for whom we are now considering a tumor necrosis factor inhibitor such as etanercept."

For patients with CF-related arthropathy and other complications, "early diagnosis is essential," Dr. Jawad said, because joint pain, swelling, and limitation of movement may become disabling and interfere with exercise and chest clearance, all of which are essential components of the treatment schedule for CF.

Although NSAIDs usually control symptoms, half of the patients needed DMARDs as well.

Early diagnosis and appropriate management are especially important for CF patients, because joint pain, swelling, and limitation of movement may become disabling and interfere with mobility, exercise, and clearing the airway of thick mucus, all essential components of CF daily treatment.

Up to 13% of one cohort of adults with cystic fibrosis were affected by musculoskeletal complications, judging from data presented at the annual European Congress of Rheumatology by Dr. Ali Jawad of the Royal London Hospital and London Chest Hospital.

Because people with cystic fibrosis (CF) are living into adulthood these days, it has become clear that the same bone and joint manifestations of CF that are well known to the physicians who take care of them continue to be an issue for these patients in adulthood. But these bone manifestations have received very little attention in adults, Dr. Jawad said in an interview. Unless these problems are diagnosed early, they are likely to become disabling and interfere with CF treatment, he added.

"From our perspective, it’s a new type of disease involvement. We don’t seem to see the episodic or the hypertrophic osteoarthropathy. Is this because there is now better treatment for these patients? Most of the series reported were over the last decade. To summarize: Unlike other cases, we had no cases of large-joint episodic arthritis or hypertrophic osteoarthropathy; instead, our patients showed a polyarthritis with an age of onset of 25 in females and 38 in men. In addition to NSAIDs, a lot of these patients require DMARDs [disease-modifying antirheumatic drugs], and the important thing is that these patients need recognition because they depend on their mobility and exercise for chest clearance every day as the central component of the treatment of cystic fibrosis."

The study involved 143 adults with cystic fibrosis who attended the quarterly musculoskeletal clinic at the hospital’s CF unit.

With his coinvestigators, Dr. Jawad found that more than 13% of CF patients (aged 16 and older) in the cohort were affected by musculoskeletal complications. The age of onset was lower for female patients than males.

In the cohort, 7% of all patients were seen to have CF-related arthropathy (CFA), which manifests itself in recurrent episodes of swelling and stiffness in the large joints. In all cases, CFA took the form of polyarthralgia. Reports of previous research by other investigators have shown that CFA is a relatively infrequent complication, occurring in 2%-8.5% of the CF population.

Other musculoskeletal diseases seen in the cohort included spondyloarthritis, chondromalacia patellae, vitamin D deficiency, back pain, and rotator cuff tendinopathy. One patient had erosive disease on ultrasound examination, but that condition could not be confirmed by x-ray. None was seen to have hypertrophic osteoarthropathy, which is characterized by abnormal proliferation of the skin and bone tissue at the distal parts of the extremities.

"Our CF service is multidisciplinary, and includes practitioners from other disciplines such as hepatology, endocrinology, and rheumatology, along with specialist nurses, physiotherapists, and a nutritionist," Dr. Jawad said. Because most of the patients in the service receive nutritional advice, he added, vitamin D deficiency was rare.

Patients are customarily started on NSAIDs and, if these prove insufficient, are moved on to DMARDs. "Patients’ [responses] to DMARDs vary," Dr. Jawad said. "We initially start with sulfasalazine and/or hydroxychloroquine. If there is no response, we add or replace one of these with methotrexate. We have one patient on methotrexate for whom we are now considering a tumor necrosis factor inhibitor such as etanercept."

For patients with CF-related arthropathy and other complications, "early diagnosis is essential," Dr. Jawad said, because joint pain, swelling, and limitation of movement may become disabling and interfere with exercise and chest clearance, all of which are essential components of the treatment schedule for CF.

Although NSAIDs usually control symptoms, half of the patients needed DMARDs as well.

Early diagnosis and appropriate management are especially important for CF patients, because joint pain, swelling, and limitation of movement may become disabling and interfere with mobility, exercise, and clearing the airway of thick mucus, all essential components of CF daily treatment.

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.