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TNF Inhibitors May Slow Plaque Progression

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TNF Inhibitors May Slow Plaque Progression

Major Finding: Among 154 patients with rheumatoid arthritis, those taking TNF inhibitors had significantly less arterial plaque load progression than did those not taking the drug.

Data Source: A subanalysis of the ESCAPE RA study.

Disclosures: The ESCAPE RA trial was primarily sponsored by the National Institutes of Health. The subanalysis was sponsored by the American College of Rheumatology Research and Education Foundation. None of the authors reported any financial conflicts.

Tumor necrosis factor–inhibiting drugs may moderate atherosclerosis progression in patients with rheumatoid arthritis, a prospective study has suggested.

Compared with patients who did not get the drugs, those treated with TNF inhibitors had a 37% lower rate of plaque progression in the common carotid artery, Dr. Jon T. Giles and his colleagues reported in Arthritis & Rheumatism (2011 [doi:10.1002/art.30542]).

“Our observation that TNF-inhibitor treated patients [had a 37% reduction in arterial plaque] provides some human confirmation of a link between cytokines and atherosclerosis,” wrote Dr. Giles of New York Presbyterian–Columbia University Medical Center, New York, and his coauthors. “However, it is unclear whether this effect is due to TNF inhibition per se, and is thus a unique effect of the TNF inhibitors, or is a general anti-inflammatory effect.”

The study also found a significantly increased rate of progression with glucocorticoid exposure – a relationship that seemed to be attenuated by the concurrent use of statins.

The 3-year study was a subanalysis of the ESCAPE RA (Evaluation of Subclinical Cardiovascular Disease and Predictors of Events in Rheumatoid Arthritis) cohort study, which looked at subclinical cardiovascular disease. This analysis examined intima-medial thickness in the common and internal carotid arteries and the internal carotid artery bulb among 154 patients with rheumatoid arthritis, none of whom had prior cardiovascular disease. All underwent carotid ultrasound at 1 and 3 years.

The patients' mean age was 59 years at baseline, and they had had rheumatoid arthritis for a mean of 8.5 years.

In all, 42% were taking TNF inhibitors, and 86% were taking a nonbiologic disease-modifying antirheumatic drug. The mean cumulative prednisone dose was 3.1 grams.

Overall, plaque deposits grew at a median rate of 16 mcm/year in the common carotid artery; 82% showed some level of increase. The median plaque increase in the internal carotid artery was 25 mcm/year; 82% of patients also showed some level of plaque increase in this artery.

At baseline, 38% of patients showed no stenosis in the internal carotid artery due to plaque, 55% showed plaque stenosis of up to 24%, and 7% had plaque stenosis of 35%-50%. There were no patients with arterial plaque stenosis of more than 50%.

Among the 58 patients without plaque at baseline, 8 (14%) showed some new plaque at 3 years – a progression rate of 4 patients per 100 person-years. Among the 96 patients with plaque at baseline, 5% (5) had increased plaque at 3 years – a progression rate of 1.6 patients per 100 person-years. In the remaining 91 patients with plaque at baseline, 89% had the same degree of plaque at 3 years and 6 patients (7%) showed less plaque stenosis, the authors noted.

In a multivariate analysis, two disease characteristics were significantly associated with plaque progression in the common carotid artery: disease duration and TNF-inhibitor use.

The rate of change in common carotid plaque was doubled in the first tertile of disease duration (up to 6 years), compared with the second or third tertiles (7-14 years and more than 14 years). The rate of change was not significantly different from the second to third tertiles of disease duration.

Framingham risk score did significantly affect plaque change in the group with shortest disease duration, however. The rate of change was significantly higher among those with higher risk scores or diabetes than in those with lower risk scores (33 vs. 20 mcm/year). “In contrast … progression rates were identical for RA patients with longer-standing disease, regardless of Framingham score,” the authors wrote.

Statin therapy exerted a significant, positive effect on plaque progression in those with longer-standing disease. Compared with patients who were not taking a statin at baseline, those who were had significantly less annual progression of plaque (1 vs. 15 mcm/year). Statins exerted no significant effect on patients with the shortest disease duration.

Baseline use of TNF inhibitors reduced the annual progression rate by 37% compared with those not using the drugs at baseline (14 vs. 22 mcm/year). This difference remained significant even after adjusting for demographics, lifestyle characteristics, Framingham score, and other disease characteristics.

In the internal carotid artery, prior glucocorticoid exposure was significantly related to higher annual plaque change. “This association was modified by statin use, as the association of cumulative prednisone exposure with the adjusted average yearly change … was attenuated, yet remained significant, in participants receiving statins at baseline,” the authors noted.

 

 

For the internal carotid artery bulb, the authors found four significant predictors of plaque change: hormone replacement therapy, cumulative average swollen joint count, cumulative C-reactive protein level, and age. Neither exposure to TNF inhibitors nor exposure to glucocorticoids was related to plaque progression in the bulb.

C-reactive protein did not exert a linear effect on plaque progression or on the appearance of incident plaque until it reached 12 mg/L or more. This threshold of change was significantly lower in patients with higher Framingham scores or diabetes at baseline (5 mg/L).

The role of statins in modifying progression is complicated, the authors stated. “Notably, statin use was associated with almost no progression of [common carotid plaque] in RA patients with longer disease duration, an observation supporting the use of statins in RA,” they said.

“Interestingly, however, statin use was not associated with lower [common carotid progression] among participants with earlier disease. This may suggest differing mechanisms for [common carotid plaque] progression in early vs. late disease.”

The additional finding that statins attenuated the risk exerted by glucocorticoid exposure “deserves additional study and, short of a confirmatory trial, suggests that statins could be considered in RA patients receiving glucocorticoids.”

Baseline TNF inhibitor use reduced the annual progression rate by 37% compared with those not using the drugs.

Source DR. GILES

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Major Finding: Among 154 patients with rheumatoid arthritis, those taking TNF inhibitors had significantly less arterial plaque load progression than did those not taking the drug.

Data Source: A subanalysis of the ESCAPE RA study.

Disclosures: The ESCAPE RA trial was primarily sponsored by the National Institutes of Health. The subanalysis was sponsored by the American College of Rheumatology Research and Education Foundation. None of the authors reported any financial conflicts.

Tumor necrosis factor–inhibiting drugs may moderate atherosclerosis progression in patients with rheumatoid arthritis, a prospective study has suggested.

Compared with patients who did not get the drugs, those treated with TNF inhibitors had a 37% lower rate of plaque progression in the common carotid artery, Dr. Jon T. Giles and his colleagues reported in Arthritis & Rheumatism (2011 [doi:10.1002/art.30542]).

“Our observation that TNF-inhibitor treated patients [had a 37% reduction in arterial plaque] provides some human confirmation of a link between cytokines and atherosclerosis,” wrote Dr. Giles of New York Presbyterian–Columbia University Medical Center, New York, and his coauthors. “However, it is unclear whether this effect is due to TNF inhibition per se, and is thus a unique effect of the TNF inhibitors, or is a general anti-inflammatory effect.”

The study also found a significantly increased rate of progression with glucocorticoid exposure – a relationship that seemed to be attenuated by the concurrent use of statins.

The 3-year study was a subanalysis of the ESCAPE RA (Evaluation of Subclinical Cardiovascular Disease and Predictors of Events in Rheumatoid Arthritis) cohort study, which looked at subclinical cardiovascular disease. This analysis examined intima-medial thickness in the common and internal carotid arteries and the internal carotid artery bulb among 154 patients with rheumatoid arthritis, none of whom had prior cardiovascular disease. All underwent carotid ultrasound at 1 and 3 years.

The patients' mean age was 59 years at baseline, and they had had rheumatoid arthritis for a mean of 8.5 years.

In all, 42% were taking TNF inhibitors, and 86% were taking a nonbiologic disease-modifying antirheumatic drug. The mean cumulative prednisone dose was 3.1 grams.

Overall, plaque deposits grew at a median rate of 16 mcm/year in the common carotid artery; 82% showed some level of increase. The median plaque increase in the internal carotid artery was 25 mcm/year; 82% of patients also showed some level of plaque increase in this artery.

At baseline, 38% of patients showed no stenosis in the internal carotid artery due to plaque, 55% showed plaque stenosis of up to 24%, and 7% had plaque stenosis of 35%-50%. There were no patients with arterial plaque stenosis of more than 50%.

Among the 58 patients without plaque at baseline, 8 (14%) showed some new plaque at 3 years – a progression rate of 4 patients per 100 person-years. Among the 96 patients with plaque at baseline, 5% (5) had increased plaque at 3 years – a progression rate of 1.6 patients per 100 person-years. In the remaining 91 patients with plaque at baseline, 89% had the same degree of plaque at 3 years and 6 patients (7%) showed less plaque stenosis, the authors noted.

In a multivariate analysis, two disease characteristics were significantly associated with plaque progression in the common carotid artery: disease duration and TNF-inhibitor use.

The rate of change in common carotid plaque was doubled in the first tertile of disease duration (up to 6 years), compared with the second or third tertiles (7-14 years and more than 14 years). The rate of change was not significantly different from the second to third tertiles of disease duration.

Framingham risk score did significantly affect plaque change in the group with shortest disease duration, however. The rate of change was significantly higher among those with higher risk scores or diabetes than in those with lower risk scores (33 vs. 20 mcm/year). “In contrast … progression rates were identical for RA patients with longer-standing disease, regardless of Framingham score,” the authors wrote.

Statin therapy exerted a significant, positive effect on plaque progression in those with longer-standing disease. Compared with patients who were not taking a statin at baseline, those who were had significantly less annual progression of plaque (1 vs. 15 mcm/year). Statins exerted no significant effect on patients with the shortest disease duration.

Baseline use of TNF inhibitors reduced the annual progression rate by 37% compared with those not using the drugs at baseline (14 vs. 22 mcm/year). This difference remained significant even after adjusting for demographics, lifestyle characteristics, Framingham score, and other disease characteristics.

In the internal carotid artery, prior glucocorticoid exposure was significantly related to higher annual plaque change. “This association was modified by statin use, as the association of cumulative prednisone exposure with the adjusted average yearly change … was attenuated, yet remained significant, in participants receiving statins at baseline,” the authors noted.

 

 

For the internal carotid artery bulb, the authors found four significant predictors of plaque change: hormone replacement therapy, cumulative average swollen joint count, cumulative C-reactive protein level, and age. Neither exposure to TNF inhibitors nor exposure to glucocorticoids was related to plaque progression in the bulb.

C-reactive protein did not exert a linear effect on plaque progression or on the appearance of incident plaque until it reached 12 mg/L or more. This threshold of change was significantly lower in patients with higher Framingham scores or diabetes at baseline (5 mg/L).

The role of statins in modifying progression is complicated, the authors stated. “Notably, statin use was associated with almost no progression of [common carotid plaque] in RA patients with longer disease duration, an observation supporting the use of statins in RA,” they said.

“Interestingly, however, statin use was not associated with lower [common carotid progression] among participants with earlier disease. This may suggest differing mechanisms for [common carotid plaque] progression in early vs. late disease.”

The additional finding that statins attenuated the risk exerted by glucocorticoid exposure “deserves additional study and, short of a confirmatory trial, suggests that statins could be considered in RA patients receiving glucocorticoids.”

Baseline TNF inhibitor use reduced the annual progression rate by 37% compared with those not using the drugs.

Source DR. GILES

Major Finding: Among 154 patients with rheumatoid arthritis, those taking TNF inhibitors had significantly less arterial plaque load progression than did those not taking the drug.

Data Source: A subanalysis of the ESCAPE RA study.

Disclosures: The ESCAPE RA trial was primarily sponsored by the National Institutes of Health. The subanalysis was sponsored by the American College of Rheumatology Research and Education Foundation. None of the authors reported any financial conflicts.

Tumor necrosis factor–inhibiting drugs may moderate atherosclerosis progression in patients with rheumatoid arthritis, a prospective study has suggested.

Compared with patients who did not get the drugs, those treated with TNF inhibitors had a 37% lower rate of plaque progression in the common carotid artery, Dr. Jon T. Giles and his colleagues reported in Arthritis & Rheumatism (2011 [doi:10.1002/art.30542]).

“Our observation that TNF-inhibitor treated patients [had a 37% reduction in arterial plaque] provides some human confirmation of a link between cytokines and atherosclerosis,” wrote Dr. Giles of New York Presbyterian–Columbia University Medical Center, New York, and his coauthors. “However, it is unclear whether this effect is due to TNF inhibition per se, and is thus a unique effect of the TNF inhibitors, or is a general anti-inflammatory effect.”

The study also found a significantly increased rate of progression with glucocorticoid exposure – a relationship that seemed to be attenuated by the concurrent use of statins.

The 3-year study was a subanalysis of the ESCAPE RA (Evaluation of Subclinical Cardiovascular Disease and Predictors of Events in Rheumatoid Arthritis) cohort study, which looked at subclinical cardiovascular disease. This analysis examined intima-medial thickness in the common and internal carotid arteries and the internal carotid artery bulb among 154 patients with rheumatoid arthritis, none of whom had prior cardiovascular disease. All underwent carotid ultrasound at 1 and 3 years.

The patients' mean age was 59 years at baseline, and they had had rheumatoid arthritis for a mean of 8.5 years.

In all, 42% were taking TNF inhibitors, and 86% were taking a nonbiologic disease-modifying antirheumatic drug. The mean cumulative prednisone dose was 3.1 grams.

Overall, plaque deposits grew at a median rate of 16 mcm/year in the common carotid artery; 82% showed some level of increase. The median plaque increase in the internal carotid artery was 25 mcm/year; 82% of patients also showed some level of plaque increase in this artery.

At baseline, 38% of patients showed no stenosis in the internal carotid artery due to plaque, 55% showed plaque stenosis of up to 24%, and 7% had plaque stenosis of 35%-50%. There were no patients with arterial plaque stenosis of more than 50%.

Among the 58 patients without plaque at baseline, 8 (14%) showed some new plaque at 3 years – a progression rate of 4 patients per 100 person-years. Among the 96 patients with plaque at baseline, 5% (5) had increased plaque at 3 years – a progression rate of 1.6 patients per 100 person-years. In the remaining 91 patients with plaque at baseline, 89% had the same degree of plaque at 3 years and 6 patients (7%) showed less plaque stenosis, the authors noted.

In a multivariate analysis, two disease characteristics were significantly associated with plaque progression in the common carotid artery: disease duration and TNF-inhibitor use.

The rate of change in common carotid plaque was doubled in the first tertile of disease duration (up to 6 years), compared with the second or third tertiles (7-14 years and more than 14 years). The rate of change was not significantly different from the second to third tertiles of disease duration.

Framingham risk score did significantly affect plaque change in the group with shortest disease duration, however. The rate of change was significantly higher among those with higher risk scores or diabetes than in those with lower risk scores (33 vs. 20 mcm/year). “In contrast … progression rates were identical for RA patients with longer-standing disease, regardless of Framingham score,” the authors wrote.

Statin therapy exerted a significant, positive effect on plaque progression in those with longer-standing disease. Compared with patients who were not taking a statin at baseline, those who were had significantly less annual progression of plaque (1 vs. 15 mcm/year). Statins exerted no significant effect on patients with the shortest disease duration.

Baseline use of TNF inhibitors reduced the annual progression rate by 37% compared with those not using the drugs at baseline (14 vs. 22 mcm/year). This difference remained significant even after adjusting for demographics, lifestyle characteristics, Framingham score, and other disease characteristics.

In the internal carotid artery, prior glucocorticoid exposure was significantly related to higher annual plaque change. “This association was modified by statin use, as the association of cumulative prednisone exposure with the adjusted average yearly change … was attenuated, yet remained significant, in participants receiving statins at baseline,” the authors noted.

 

 

For the internal carotid artery bulb, the authors found four significant predictors of plaque change: hormone replacement therapy, cumulative average swollen joint count, cumulative C-reactive protein level, and age. Neither exposure to TNF inhibitors nor exposure to glucocorticoids was related to plaque progression in the bulb.

C-reactive protein did not exert a linear effect on plaque progression or on the appearance of incident plaque until it reached 12 mg/L or more. This threshold of change was significantly lower in patients with higher Framingham scores or diabetes at baseline (5 mg/L).

The role of statins in modifying progression is complicated, the authors stated. “Notably, statin use was associated with almost no progression of [common carotid plaque] in RA patients with longer disease duration, an observation supporting the use of statins in RA,” they said.

“Interestingly, however, statin use was not associated with lower [common carotid progression] among participants with earlier disease. This may suggest differing mechanisms for [common carotid plaque] progression in early vs. late disease.”

The additional finding that statins attenuated the risk exerted by glucocorticoid exposure “deserves additional study and, short of a confirmatory trial, suggests that statins could be considered in RA patients receiving glucocorticoids.”

Baseline TNF inhibitor use reduced the annual progression rate by 37% compared with those not using the drugs.

Source DR. GILES

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Manage Cardiovascular Risk in Vulnerable RA Patients

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Manage Cardiovascular Risk in Vulnerable RA Patients

The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.

Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent MI occurred more often in RA patients, and sudden death was more likely in these patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).

Some experts say RA is now equivalent to diabetes in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.

The European League Against Rheumatism has proposed multiplying conventional cardiovascular risk models by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).

This approach is not well validated, and may not be widely used, she said. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. It suggests that considering RA as a risk factor equivalent to diabetes – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.

Consider yearly cardiovascular risk screening, she said. The benefits of imaging and biomarkers are unclear, and no guidelines are in place. As a management strategy, aspirin therapy might be useful, but should be considered in the context of the patient's other medications. Statins are a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.

Definite treatment strategies for RA patients include weight management for overweight patients, to help reduce inflammation, as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are imperative, Dr. Bathon said.

She noted that conventional risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays a role.

Dr. Bathon said she had no disclosures.

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The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.

Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent MI occurred more often in RA patients, and sudden death was more likely in these patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).

Some experts say RA is now equivalent to diabetes in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.

The European League Against Rheumatism has proposed multiplying conventional cardiovascular risk models by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).

This approach is not well validated, and may not be widely used, she said. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. It suggests that considering RA as a risk factor equivalent to diabetes – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.

Consider yearly cardiovascular risk screening, she said. The benefits of imaging and biomarkers are unclear, and no guidelines are in place. As a management strategy, aspirin therapy might be useful, but should be considered in the context of the patient's other medications. Statins are a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.

Definite treatment strategies for RA patients include weight management for overweight patients, to help reduce inflammation, as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are imperative, Dr. Bathon said.

She noted that conventional risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays a role.

Dr. Bathon said she had no disclosures.

The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.

Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent MI occurred more often in RA patients, and sudden death was more likely in these patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).

Some experts say RA is now equivalent to diabetes in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.

The European League Against Rheumatism has proposed multiplying conventional cardiovascular risk models by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).

This approach is not well validated, and may not be widely used, she said. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. It suggests that considering RA as a risk factor equivalent to diabetes – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.

Consider yearly cardiovascular risk screening, she said. The benefits of imaging and biomarkers are unclear, and no guidelines are in place. As a management strategy, aspirin therapy might be useful, but should be considered in the context of the patient's other medications. Statins are a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.

Definite treatment strategies for RA patients include weight management for overweight patients, to help reduce inflammation, as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are imperative, Dr. Bathon said.

She noted that conventional risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays a role.

Dr. Bathon said she had no disclosures.

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Hyaluronic Acid Improves Function in Knee OA : Number of responders increases after each treatment cycle; benefits persist at 1 year follow-up.

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Hyaluronic Acid Improves Function in Knee OA : Number of responders increases after each treatment cycle; benefits persist at 1 year follow-up.

Major Finding: Compared with saline injections, hyaluronic injections eased pain and improved function in 22% more patients.

Data Source: A double-blinded randomized controlled trial of 306 patients with knee osteoarthritis.

Disclosures: The study was supported by Tedec Meiji Farma SA. Dr. Navarro-Sarabia and coauthors received research funds from the company as study investigators. Two coauthors are Tedec Meiji Farma SA employees.

Repeated intra-articular injections of hyaluronic acid appear to lessen pain and improve function in knee osteoarthritis between treatment cycles, and for up to a year later.

The 40-month AMELIA (Osteoarthritis Modifying Effects of Long-Term Intra-Articular Adant) project found that, compared with those getting saline as a placebo injection, patients who got the treatment were 22% more likely to experience a clinical response – a 50% or greater improvement in pain or function (80% vs. 66%; risk ratio 1.22).

However, wrote Dr. Federico Navarro-Sarabia and his colleagues, the study could not determine why the improvement persisted as long as it did after treatments stopped.

“In this regard, it is not possible to establish whether this carry-over effect reflects a true disease remission or just a modification of the natural course of the disease,” the investigators wrote (Ann. Rheum. Dis. 2011 Aug. 17 [doi: 10.1136/ard.2011.152017]).

AMELIA comprised 306 patients with knee osteoarthritis. They were randomized to four cycles of five weekly injections. The treatment groups received 2.5 mL 1% sodium hyaluronate derived from Streptococcus zooepidemicus. The placebo group received saline injections. Patients and evaluators were both blinded to the treatments by using a blinded evaluator and an unblinded investigator to administer the injections.

Follow-up occurred during the 6 months after cycles 1 and 2; and 1 year after cycles 3 and 4. Patients were allowed to use aspirin or paracetamol, and short durations of nonsteroidal anti-inflammatories. “However, for 24 h and 1 week before efficacy evaluation, patients were required to abstain from any paracetamol or NSAID, respectively,” the researchers wrote. No corticosteroid injections were allowed in the treated knee throughout the entire study.

The patients were mostly women (87%), with a mean age of 63 years. The mean body mass index was 28 (kg/m

Of the 306 randomized, 109 in the treatment group and 94 in the placebo group completed the entire study. In the treatment group, discontinuation was due to lack of efficacy (8), patient decision (12), adverse events (12), and investigator decision (1). The rest were lost to follow-up or left for other reasons. In the placebo group, reasons were lack of efficacy (19), patient decision (13), adverse events (16), and investigator decision (1). The rest were lost to follow-up or left for other reasons. Outcomes were assessed in an intent-to-treat analysis.

At the end of the 40-month study period, 22% more treated patients than placebo patients were judged responders according to the Osteoarthritis Research Society International 2004 criteria – a significant difference.

However, the number of responders in the treatment group progressively increased after each cycle, from 71% after the first cycle to 80% after the last cycle. Response rates in the placebo group remained stable throughout the study (68% after the first cycle and 66% after the last cycle).

The chances of response seemed to increase as the study progressed, the authors noted. Among the nonresponders in the treatment group, 54% became responders later on. Similarly, 38% of the nonresponders in the placebo group eventually became responders.

The high placebo response is not an unusual finding in osteoarthritis trials, said Dr. Navarro-Sarabi of Hospital Universitario Virgen Macarena, Seville, Spain, and coauthors.

“In AMELIA, however, the success of the study was in fact accentuated by the high placebo efficacy detected, making the results found [80% vs. 68%] even more clinically meaningful and remarkable.”

Most of the patients (71% of each group) used either an NSAID or paracetamol as a rescue medication during the study. Among the 48% who took paracetamol over the study's course, the mean daily dose declined by 27% in the treatment group and 4% in the placebo group.

Twenty-nine adverse events occurred (15 in the treatment group and 14 in the placebo group), among 22 patients (11 in each group). These included allergic reaction (three in each treatment group), bleeding and pain at the injection site, arthralgia, and other events.

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Nonresponders Become Responders

I think this is a valuable study. It adds important information on the use of hyaluronic acid injections for osteoarthritis of the knee.

▸ First, under controlled conditions with a saline control parallel group, a series of four courses of repeat series of injections can provide significantly greater benefit than in the control group.

 

 

▸ Second, that the repeat series of injections were safe with this bacteria-derived product; there was no increase in adverse events.

▸ Third – which is a new finding to my knowledge – is that there is a subset of patients who don't respond to the initial series of injections but who did respond to repeat series of injections.

▸ Fourth – this is the first controlled study to my knowledge that has demonstrated benefit lasting for at least a year following the repeated series of injections.

Statistically, they used the OMERACT-OARSI responder criteria, a robust technique that separates responders and nonresponders.

This is the kind of study that reinforces the way I practice and may even change it. If I have someone with only a borderline response to the first injections, I now might give it a second try.

One thing I do question is the dropout rate. With a dropout rate of 27% in the treatment group and 39% in the saline group, you wonder if the significance of the findings would change if they had completed the trial.

ROY ALTMAN, M.D., is professor of rheumatology and immunology at the University of California, Los Angeles. He reported having no financial relationship to disclose relevant to Adant. Dr. Altman said that he consults for Ferring, Fidia, Novozyme, and Smith & Nephew/Q-Med, all of which make other hyaluronic acid products.

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Major Finding: Compared with saline injections, hyaluronic injections eased pain and improved function in 22% more patients.

Data Source: A double-blinded randomized controlled trial of 306 patients with knee osteoarthritis.

Disclosures: The study was supported by Tedec Meiji Farma SA. Dr. Navarro-Sarabia and coauthors received research funds from the company as study investigators. Two coauthors are Tedec Meiji Farma SA employees.

Repeated intra-articular injections of hyaluronic acid appear to lessen pain and improve function in knee osteoarthritis between treatment cycles, and for up to a year later.

The 40-month AMELIA (Osteoarthritis Modifying Effects of Long-Term Intra-Articular Adant) project found that, compared with those getting saline as a placebo injection, patients who got the treatment were 22% more likely to experience a clinical response – a 50% or greater improvement in pain or function (80% vs. 66%; risk ratio 1.22).

However, wrote Dr. Federico Navarro-Sarabia and his colleagues, the study could not determine why the improvement persisted as long as it did after treatments stopped.

“In this regard, it is not possible to establish whether this carry-over effect reflects a true disease remission or just a modification of the natural course of the disease,” the investigators wrote (Ann. Rheum. Dis. 2011 Aug. 17 [doi: 10.1136/ard.2011.152017]).

AMELIA comprised 306 patients with knee osteoarthritis. They were randomized to four cycles of five weekly injections. The treatment groups received 2.5 mL 1% sodium hyaluronate derived from Streptococcus zooepidemicus. The placebo group received saline injections. Patients and evaluators were both blinded to the treatments by using a blinded evaluator and an unblinded investigator to administer the injections.

Follow-up occurred during the 6 months after cycles 1 and 2; and 1 year after cycles 3 and 4. Patients were allowed to use aspirin or paracetamol, and short durations of nonsteroidal anti-inflammatories. “However, for 24 h and 1 week before efficacy evaluation, patients were required to abstain from any paracetamol or NSAID, respectively,” the researchers wrote. No corticosteroid injections were allowed in the treated knee throughout the entire study.

The patients were mostly women (87%), with a mean age of 63 years. The mean body mass index was 28 (kg/m

Of the 306 randomized, 109 in the treatment group and 94 in the placebo group completed the entire study. In the treatment group, discontinuation was due to lack of efficacy (8), patient decision (12), adverse events (12), and investigator decision (1). The rest were lost to follow-up or left for other reasons. In the placebo group, reasons were lack of efficacy (19), patient decision (13), adverse events (16), and investigator decision (1). The rest were lost to follow-up or left for other reasons. Outcomes were assessed in an intent-to-treat analysis.

At the end of the 40-month study period, 22% more treated patients than placebo patients were judged responders according to the Osteoarthritis Research Society International 2004 criteria – a significant difference.

However, the number of responders in the treatment group progressively increased after each cycle, from 71% after the first cycle to 80% after the last cycle. Response rates in the placebo group remained stable throughout the study (68% after the first cycle and 66% after the last cycle).

The chances of response seemed to increase as the study progressed, the authors noted. Among the nonresponders in the treatment group, 54% became responders later on. Similarly, 38% of the nonresponders in the placebo group eventually became responders.

The high placebo response is not an unusual finding in osteoarthritis trials, said Dr. Navarro-Sarabi of Hospital Universitario Virgen Macarena, Seville, Spain, and coauthors.

“In AMELIA, however, the success of the study was in fact accentuated by the high placebo efficacy detected, making the results found [80% vs. 68%] even more clinically meaningful and remarkable.”

Most of the patients (71% of each group) used either an NSAID or paracetamol as a rescue medication during the study. Among the 48% who took paracetamol over the study's course, the mean daily dose declined by 27% in the treatment group and 4% in the placebo group.

Twenty-nine adverse events occurred (15 in the treatment group and 14 in the placebo group), among 22 patients (11 in each group). These included allergic reaction (three in each treatment group), bleeding and pain at the injection site, arthralgia, and other events.

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Nonresponders Become Responders

I think this is a valuable study. It adds important information on the use of hyaluronic acid injections for osteoarthritis of the knee.

▸ First, under controlled conditions with a saline control parallel group, a series of four courses of repeat series of injections can provide significantly greater benefit than in the control group.

 

 

▸ Second, that the repeat series of injections were safe with this bacteria-derived product; there was no increase in adverse events.

▸ Third – which is a new finding to my knowledge – is that there is a subset of patients who don't respond to the initial series of injections but who did respond to repeat series of injections.

▸ Fourth – this is the first controlled study to my knowledge that has demonstrated benefit lasting for at least a year following the repeated series of injections.

Statistically, they used the OMERACT-OARSI responder criteria, a robust technique that separates responders and nonresponders.

This is the kind of study that reinforces the way I practice and may even change it. If I have someone with only a borderline response to the first injections, I now might give it a second try.

One thing I do question is the dropout rate. With a dropout rate of 27% in the treatment group and 39% in the saline group, you wonder if the significance of the findings would change if they had completed the trial.

ROY ALTMAN, M.D., is professor of rheumatology and immunology at the University of California, Los Angeles. He reported having no financial relationship to disclose relevant to Adant. Dr. Altman said that he consults for Ferring, Fidia, Novozyme, and Smith & Nephew/Q-Med, all of which make other hyaluronic acid products.

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Major Finding: Compared with saline injections, hyaluronic injections eased pain and improved function in 22% more patients.

Data Source: A double-blinded randomized controlled trial of 306 patients with knee osteoarthritis.

Disclosures: The study was supported by Tedec Meiji Farma SA. Dr. Navarro-Sarabia and coauthors received research funds from the company as study investigators. Two coauthors are Tedec Meiji Farma SA employees.

Repeated intra-articular injections of hyaluronic acid appear to lessen pain and improve function in knee osteoarthritis between treatment cycles, and for up to a year later.

The 40-month AMELIA (Osteoarthritis Modifying Effects of Long-Term Intra-Articular Adant) project found that, compared with those getting saline as a placebo injection, patients who got the treatment were 22% more likely to experience a clinical response – a 50% or greater improvement in pain or function (80% vs. 66%; risk ratio 1.22).

However, wrote Dr. Federico Navarro-Sarabia and his colleagues, the study could not determine why the improvement persisted as long as it did after treatments stopped.

“In this regard, it is not possible to establish whether this carry-over effect reflects a true disease remission or just a modification of the natural course of the disease,” the investigators wrote (Ann. Rheum. Dis. 2011 Aug. 17 [doi: 10.1136/ard.2011.152017]).

AMELIA comprised 306 patients with knee osteoarthritis. They were randomized to four cycles of five weekly injections. The treatment groups received 2.5 mL 1% sodium hyaluronate derived from Streptococcus zooepidemicus. The placebo group received saline injections. Patients and evaluators were both blinded to the treatments by using a blinded evaluator and an unblinded investigator to administer the injections.

Follow-up occurred during the 6 months after cycles 1 and 2; and 1 year after cycles 3 and 4. Patients were allowed to use aspirin or paracetamol, and short durations of nonsteroidal anti-inflammatories. “However, for 24 h and 1 week before efficacy evaluation, patients were required to abstain from any paracetamol or NSAID, respectively,” the researchers wrote. No corticosteroid injections were allowed in the treated knee throughout the entire study.

The patients were mostly women (87%), with a mean age of 63 years. The mean body mass index was 28 (kg/m

Of the 306 randomized, 109 in the treatment group and 94 in the placebo group completed the entire study. In the treatment group, discontinuation was due to lack of efficacy (8), patient decision (12), adverse events (12), and investigator decision (1). The rest were lost to follow-up or left for other reasons. In the placebo group, reasons were lack of efficacy (19), patient decision (13), adverse events (16), and investigator decision (1). The rest were lost to follow-up or left for other reasons. Outcomes were assessed in an intent-to-treat analysis.

At the end of the 40-month study period, 22% more treated patients than placebo patients were judged responders according to the Osteoarthritis Research Society International 2004 criteria – a significant difference.

However, the number of responders in the treatment group progressively increased after each cycle, from 71% after the first cycle to 80% after the last cycle. Response rates in the placebo group remained stable throughout the study (68% after the first cycle and 66% after the last cycle).

The chances of response seemed to increase as the study progressed, the authors noted. Among the nonresponders in the treatment group, 54% became responders later on. Similarly, 38% of the nonresponders in the placebo group eventually became responders.

The high placebo response is not an unusual finding in osteoarthritis trials, said Dr. Navarro-Sarabi of Hospital Universitario Virgen Macarena, Seville, Spain, and coauthors.

“In AMELIA, however, the success of the study was in fact accentuated by the high placebo efficacy detected, making the results found [80% vs. 68%] even more clinically meaningful and remarkable.”

Most of the patients (71% of each group) used either an NSAID or paracetamol as a rescue medication during the study. Among the 48% who took paracetamol over the study's course, the mean daily dose declined by 27% in the treatment group and 4% in the placebo group.

Twenty-nine adverse events occurred (15 in the treatment group and 14 in the placebo group), among 22 patients (11 in each group). These included allergic reaction (three in each treatment group), bleeding and pain at the injection site, arthralgia, and other events.

View on the News

Nonresponders Become Responders

I think this is a valuable study. It adds important information on the use of hyaluronic acid injections for osteoarthritis of the knee.

▸ First, under controlled conditions with a saline control parallel group, a series of four courses of repeat series of injections can provide significantly greater benefit than in the control group.

 

 

▸ Second, that the repeat series of injections were safe with this bacteria-derived product; there was no increase in adverse events.

▸ Third – which is a new finding to my knowledge – is that there is a subset of patients who don't respond to the initial series of injections but who did respond to repeat series of injections.

▸ Fourth – this is the first controlled study to my knowledge that has demonstrated benefit lasting for at least a year following the repeated series of injections.

Statistically, they used the OMERACT-OARSI responder criteria, a robust technique that separates responders and nonresponders.

This is the kind of study that reinforces the way I practice and may even change it. If I have someone with only a borderline response to the first injections, I now might give it a second try.

One thing I do question is the dropout rate. With a dropout rate of 27% in the treatment group and 39% in the saline group, you wonder if the significance of the findings would change if they had completed the trial.

ROY ALTMAN, M.D., is professor of rheumatology and immunology at the University of California, Los Angeles. He reported having no financial relationship to disclose relevant to Adant. Dr. Altman said that he consults for Ferring, Fidia, Novozyme, and Smith & Nephew/Q-Med, all of which make other hyaluronic acid products.

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Bone Edema on MRI Predicts Rheumatoid Arthritis

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Magnetic resonance imaging evidence of bone edema in the wrist and metatarsophalangeal joints was an independent predictor of future development of rheumatoid arthritis in a prospective Danish study of patients with early undifferentiated arthritis.

Incorporating MRI bone edema findings, together with clinical and biochemical parameters, yielded a prediction model that showed unprecedented accuracy in identifying which patients would or would not develop rheumatoid arthritis, Dr. Anne Duer-Jensen of Copenhagen University Hospital at Hvidovre and Copenhagen University Hospital at Glostrup, and her associates reported in Arthritis & Rheumatism (2011;63:2192-202).

The study involved 116 patients with early undifferentiated arthritis, 23% of whom went on to meet American College of Rheumatology 1987 criteria for RA during a median 17 months of follow-up. They were matched with 24 healthy controls. The predictive model had a sensitivity of 81% and a specificity of 82% for progression to RA. Thus, it classified 82% of patients correctly.

That’s a markedly better predictive accuracy than achieved when the investigators applied the published and validated van der Helm-van Mil prediction model to the same study population. The van der Helm-van Mil model (Arthritis Rheum. 2007;56:433-40) had a 60% predictive accuracy.

Participants in the Danish study had two or more tender joints and/or two or more swollen joints among the wrist, metatarsophalangeal (MTP), proximal interphalangeal, or metacarpophalangeal joints for more than 6 weeks but less than 2 years. None of the 116 subjects had a specific rheumatologic diagnosis at baseline. Thus, they were typical of the patients often referred to rheumatologists for early undifferentiated arthritis, a condition that can morph into osteoarthritis, RA, persistent arthralgias, or nonprogressive disease.

The investigators developed their predictive model based on the findings of a multivariate logistic regression analysis that encompassed numerous variables. The final prediction model included four independent predictors of RA: serum positivity for rheumatoid factor, the presence of hand arthritis, morning stiffness lasting longer than 1 hour, and the MRI summary score for bone edema in the wrist and MTP joints that grew out of the Outcome Measures in Rheumatology Clinical Trials, or OMERACT (J. Rheumatol. 2003;30:1385-6).

Of note, in the Danish study the presence of rheumatoid factor was an independent predictor of subsequent RA, whereas a positive anti–cyclic citrullinated peptide test was not, unlike in several recent studies. MRI summary scores for bone edema proved to be a significantly more potent predictor of RA than MRI scores for synovitis or erosion.

The formula for the current iteration of the prediction model is cumbersome. A simpler version would be welcome. Toward that end, the investigators tried using MRI bone edema scores for the wrist or MTP joints alone, but they found that it unacceptably weakened the model’s predictive power.

The next step in this project will be to see how the prediction model performs in other cohorts of patients with early undifferentiated arthritis. The goal is to develop a tool that enables physicians to extend the current, highly successful early and aggressive treatment strategy for RA into the pre-RA setting.

This study was funded by the Danish Rheumatism Foundation and other foundation grants. While Dr. Duer-Jensen reported having no financial conflicts of interest, several of her associates did. Those can be found on the full text of the journal article.

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Magnetic resonance imaging evidence of bone edema in the wrist and metatarsophalangeal joints was an independent predictor of future development of rheumatoid arthritis in a prospective Danish study of patients with early undifferentiated arthritis.

Incorporating MRI bone edema findings, together with clinical and biochemical parameters, yielded a prediction model that showed unprecedented accuracy in identifying which patients would or would not develop rheumatoid arthritis, Dr. Anne Duer-Jensen of Copenhagen University Hospital at Hvidovre and Copenhagen University Hospital at Glostrup, and her associates reported in Arthritis & Rheumatism (2011;63:2192-202).

The study involved 116 patients with early undifferentiated arthritis, 23% of whom went on to meet American College of Rheumatology 1987 criteria for RA during a median 17 months of follow-up. They were matched with 24 healthy controls. The predictive model had a sensitivity of 81% and a specificity of 82% for progression to RA. Thus, it classified 82% of patients correctly.

That’s a markedly better predictive accuracy than achieved when the investigators applied the published and validated van der Helm-van Mil prediction model to the same study population. The van der Helm-van Mil model (Arthritis Rheum. 2007;56:433-40) had a 60% predictive accuracy.

Participants in the Danish study had two or more tender joints and/or two or more swollen joints among the wrist, metatarsophalangeal (MTP), proximal interphalangeal, or metacarpophalangeal joints for more than 6 weeks but less than 2 years. None of the 116 subjects had a specific rheumatologic diagnosis at baseline. Thus, they were typical of the patients often referred to rheumatologists for early undifferentiated arthritis, a condition that can morph into osteoarthritis, RA, persistent arthralgias, or nonprogressive disease.

The investigators developed their predictive model based on the findings of a multivariate logistic regression analysis that encompassed numerous variables. The final prediction model included four independent predictors of RA: serum positivity for rheumatoid factor, the presence of hand arthritis, morning stiffness lasting longer than 1 hour, and the MRI summary score for bone edema in the wrist and MTP joints that grew out of the Outcome Measures in Rheumatology Clinical Trials, or OMERACT (J. Rheumatol. 2003;30:1385-6).

Of note, in the Danish study the presence of rheumatoid factor was an independent predictor of subsequent RA, whereas a positive anti–cyclic citrullinated peptide test was not, unlike in several recent studies. MRI summary scores for bone edema proved to be a significantly more potent predictor of RA than MRI scores for synovitis or erosion.

The formula for the current iteration of the prediction model is cumbersome. A simpler version would be welcome. Toward that end, the investigators tried using MRI bone edema scores for the wrist or MTP joints alone, but they found that it unacceptably weakened the model’s predictive power.

The next step in this project will be to see how the prediction model performs in other cohorts of patients with early undifferentiated arthritis. The goal is to develop a tool that enables physicians to extend the current, highly successful early and aggressive treatment strategy for RA into the pre-RA setting.

This study was funded by the Danish Rheumatism Foundation and other foundation grants. While Dr. Duer-Jensen reported having no financial conflicts of interest, several of her associates did. Those can be found on the full text of the journal article.

Magnetic resonance imaging evidence of bone edema in the wrist and metatarsophalangeal joints was an independent predictor of future development of rheumatoid arthritis in a prospective Danish study of patients with early undifferentiated arthritis.

Incorporating MRI bone edema findings, together with clinical and biochemical parameters, yielded a prediction model that showed unprecedented accuracy in identifying which patients would or would not develop rheumatoid arthritis, Dr. Anne Duer-Jensen of Copenhagen University Hospital at Hvidovre and Copenhagen University Hospital at Glostrup, and her associates reported in Arthritis & Rheumatism (2011;63:2192-202).

The study involved 116 patients with early undifferentiated arthritis, 23% of whom went on to meet American College of Rheumatology 1987 criteria for RA during a median 17 months of follow-up. They were matched with 24 healthy controls. The predictive model had a sensitivity of 81% and a specificity of 82% for progression to RA. Thus, it classified 82% of patients correctly.

That’s a markedly better predictive accuracy than achieved when the investigators applied the published and validated van der Helm-van Mil prediction model to the same study population. The van der Helm-van Mil model (Arthritis Rheum. 2007;56:433-40) had a 60% predictive accuracy.

Participants in the Danish study had two or more tender joints and/or two or more swollen joints among the wrist, metatarsophalangeal (MTP), proximal interphalangeal, or metacarpophalangeal joints for more than 6 weeks but less than 2 years. None of the 116 subjects had a specific rheumatologic diagnosis at baseline. Thus, they were typical of the patients often referred to rheumatologists for early undifferentiated arthritis, a condition that can morph into osteoarthritis, RA, persistent arthralgias, or nonprogressive disease.

The investigators developed their predictive model based on the findings of a multivariate logistic regression analysis that encompassed numerous variables. The final prediction model included four independent predictors of RA: serum positivity for rheumatoid factor, the presence of hand arthritis, morning stiffness lasting longer than 1 hour, and the MRI summary score for bone edema in the wrist and MTP joints that grew out of the Outcome Measures in Rheumatology Clinical Trials, or OMERACT (J. Rheumatol. 2003;30:1385-6).

Of note, in the Danish study the presence of rheumatoid factor was an independent predictor of subsequent RA, whereas a positive anti–cyclic citrullinated peptide test was not, unlike in several recent studies. MRI summary scores for bone edema proved to be a significantly more potent predictor of RA than MRI scores for synovitis or erosion.

The formula for the current iteration of the prediction model is cumbersome. A simpler version would be welcome. Toward that end, the investigators tried using MRI bone edema scores for the wrist or MTP joints alone, but they found that it unacceptably weakened the model’s predictive power.

The next step in this project will be to see how the prediction model performs in other cohorts of patients with early undifferentiated arthritis. The goal is to develop a tool that enables physicians to extend the current, highly successful early and aggressive treatment strategy for RA into the pre-RA setting.

This study was funded by the Danish Rheumatism Foundation and other foundation grants. While Dr. Duer-Jensen reported having no financial conflicts of interest, several of her associates did. Those can be found on the full text of the journal article.

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Major Finding: Incorporating MRI bone edema findings, together with clinical and biochemical parameters, yielded a prediction model that had a sensitivity of 81% and a specificity of 82% for progression to RA.

Data Source: The study involved 24 healthy controls and 116 patients with early undifferentiated arthritis, 23% of whom went on to meet American College of Rheumatology 1987 criteria for RA during a median 17 months of follow-up.

Disclosures: This study was funded by the Danish Rheumatism Foundation and other foundation grants. While Dr. Duer-Jensen reported having no financial conflicts of interest, several of her associates did. Those can be found on the full text of the journal article.

Analgesic Combination May Increase GI Bleeding

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Analgesic Combination May Increase GI Bleeding

Major Finding: Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief after 10 days in adults with knee pain/osteoarthritis (P less than .01), but at the expense of an increase in presumed GI bleeding at 13 weeks.

Data Source: A study of 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day.

Disclosures: The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial found that paracetamol 3 g per day may cause similar levels of blood loss as ibuprofen 1,200 mg per day, and that the combination of the two appears to be additive, or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

“These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding,” wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. “If confirmed, this observation should lead to the re-consideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect.”

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, “Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?” Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1 g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

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Major Finding: Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief after 10 days in adults with knee pain/osteoarthritis (P less than .01), but at the expense of an increase in presumed GI bleeding at 13 weeks.

Data Source: A study of 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day.

Disclosures: The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial found that paracetamol 3 g per day may cause similar levels of blood loss as ibuprofen 1,200 mg per day, and that the combination of the two appears to be additive, or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

“These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding,” wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. “If confirmed, this observation should lead to the re-consideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect.”

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, “Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?” Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1 g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

Major Finding: Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief after 10 days in adults with knee pain/osteoarthritis (P less than .01), but at the expense of an increase in presumed GI bleeding at 13 weeks.

Data Source: A study of 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day.

Disclosures: The study was sponsored by Reckitt Benckiser Healthcare International Ltd. Dr. Doherty disclosed that he has received honoraria for attending two advisory boards for Reckitt Benckiser. In addition, one of the study authors is currently employed by the company and two others are former employees.

Combining ibuprofen and paracetamol at nonprescription doses conferred a modest improvement in pain relief in adults with knee pain/osteoarthritis. But this gain came at the expense of an increase in presumed gastrointestinal bleeding, results from a large randomized, controlled trial demonstrated.

The trial found that paracetamol 3 g per day may cause similar levels of blood loss as ibuprofen 1,200 mg per day, and that the combination of the two appears to be additive, or even synergistic in terms of the number of individuals with a decrease in hemoglobin greater than 2 g/dL.

“These results need to be confirmed, along with their clinical relevance and identification of the site of gastrointestinal bleeding,” wrote the researchers, who were led by Dr. Michael Doherty of the Arthritis UK Pain Center at Nottingham (England) City Hospital. “If confirmed, this observation should lead to the re-consideration of current recommendations for oral analgesic use in osteoarthritis and in chronic pain in general, and to the consideration of strategies to reduce this side effect.”

Over a period of 13 weeks, Dr. Doherty and his associates followed 892 adults with chronic knee pain who were randomized to one of four treatment regimens, each taken three times a day: ibuprofen (400 mg), paracetamol (1,000 mg), one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg), or two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1,000 mg).

The primary short-term efficacy end point was the difference at 10 days between groups in the WOMAC (Western Ontario McMaster Universities) osteoarthritis index pain subscale, which was normalized to a 0- to 100-mm scale.

The primary long-term efficacy end point was the patient global assessment of study medication after 13 weeks. This was determined by asking patients, “Taking into account both how your medicine worked for you and any side effects you think it caused you, how would you rate your medication as a treatment for your painful knee?” Respondents used a 5-point scale for replies (1, excellent; 2, good; 3, fair; 4, poor; 5, unacceptable).

The primary safety end point was incidence of moderate and severe adverse events reported during the study period (Ann. Rheum. Dis. 2011;70:1534-41).

Criteria for inclusion were age of at least 40 years; knee pain for most of the past 3 months and on 4 of 7 preceding days; discontinuation of current analgesics; Steinbrocker functional capacity class I-III; and pain affecting the index knee (after a washout period if currently taking analgesics) of 30 mm or greater and 80 mm or less on a 100-mm visual analog scale over the previous 48 hours for one or more of the following: walking on a flat surface, going up/down stairs, at night, sitting, lying, or standing upright.

The mean age of patients was 61 years and 51% were men. More than half of the study participants (63%) had radiographic osteoarthritis, and 85% fulfilled American College of Rheumatology criteria for the condition.

After measuring the mean change in WOMAC pain scores from baseline, the researchers found that at day 10, two combination tablets provided significantly more pain relief, compared with paracetamol alone (P less than .01). At 13 weeks, a significantly greater proportion of participants taking one or two combination tablets rated their treatment as excellent/good, compared with paracetamol alone (P = .015 and .0002, respectively).

The incidence of adverse events was comparable among groups and consisted mainly of dyspepsia, diarrhea, and nausea. However, at 13 weeks a decrease in hemoglobin level by at least 1 g/dL was observed among some participants in all treatment groups. More than two-thirds of patients taking two combination tablets experienced this decrease (38%), compared with 24% taking one combination tablet, 20% taking paracetamol monotherapy, and 20% taking ibuprofen monotherapy.

At 13 weeks, a significantly greater proportion of patients in the two combination tablet group experienced a decrease in hemoglobin level by 2 g/L or greater (6.9%), compared with their counterparts in the one combination tablet (1.8%), paracetamol (0.9%), and ibuprofen (0.9%) treatment groups.

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MRI Poised to Boost Early Detection of Osteoarthritis

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Magnetic resonance imaging has an increasingly important role in early detection and diagnosis of osteoarthritis, although for now it remains one of several diagnostic tools that also include x-rays, clinical findings, and lab results.

Physicians who treat patients with osteoarthritis (OA) need further research results to better clarify the best use of MRI in early OA detection, said Dr. Philip Conaghan, professor of musculoskeletal medicine at the University of Leeds (England).

In June, Dr. Conaghan and his colleagues on the OA Imaging Working Group for the Osteoarthritis Research Society International (OARSI) issued 11 propositions on using MRI to define OA – propositions that the group said need formal testing “regarding their diagnostic performance before they are more widely used” (Osteoarthritis Cartilage 2011;19:963-9).

The working group clearly endorsed MRI, saying that “MRI may add to the diagnosis of OA and should be incorporated into the [American College of Rheumatology] diagnostic criteria,” but in the same proposition, the working group also reiterated the role of x-ray, clinical, and laboratory parameters. Other propositions caution that “no single MRI finding is diagnostic of MRI,” and that “certain MRI changes in isolation … are not diagnostic of osteoarthritis.”

The working group's propositions included two MRI-based definitions of OA, for the tibiofemoral form and for the patellofemoral type.

In a recent talk on MRI and OA, Dr. Conaghan stressed the potential that MRI holds for early OA detection. “We need to develop an early OA culture,” similar to what has emerged for rheumatoid arthritis, he said speaking in May at the annual European Congress of Rheumatology in London. “In OA, we need a culture of early intervention” that would rely on early detection, most likely using MRI.

“Clinical features may suffice at present” for early OA detection, but MRI offers the best individualized option for assessing cartilage, bone features, and possibly the meniscus, he said. Soluble biomarkers may be more feasible” than MRI, but biomarkers need more development and for early detection are “not there yet.”

The sheer frequency of MRI lesions in OA patients may prove limiting. OA lesions appear more often on MRI than on x-rays. In five different reported series, the prevalence of cartilage defects visible by MRI in OA patients was 85%-98%, and the prevalence of osteophytes was 70%-100%, Dr. Conaghan noted. Often the MRI changes appear with no radio-graphic change visible. Other MRI changes that look like promising OA markers are bone marrow lesions and bone shape.

The OARSI Working Group defined tibiofemoral OA by MRI as either both items from group A, or one group A item and at least two from group B. The group A diagnostic features are definite osteophyte formation and full-thickness cartilage loss. The group B items are a subchondral bone marrow lesion or cyst that is not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative tear; partial-thickness cartilage loss; and bone attrition.

The working group's definition of patellofemoral OA requires both a definitive osteophyte and partial- or full-thickness cartilage loss.

Dr. Conaghan said that he had no relevant disclosures.

'We need a culture of early intervention' that would rely on early detection, most likely using MRI.

Source DR. CONAGHAN

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Magnetic resonance imaging has an increasingly important role in early detection and diagnosis of osteoarthritis, although for now it remains one of several diagnostic tools that also include x-rays, clinical findings, and lab results.

Physicians who treat patients with osteoarthritis (OA) need further research results to better clarify the best use of MRI in early OA detection, said Dr. Philip Conaghan, professor of musculoskeletal medicine at the University of Leeds (England).

In June, Dr. Conaghan and his colleagues on the OA Imaging Working Group for the Osteoarthritis Research Society International (OARSI) issued 11 propositions on using MRI to define OA – propositions that the group said need formal testing “regarding their diagnostic performance before they are more widely used” (Osteoarthritis Cartilage 2011;19:963-9).

The working group clearly endorsed MRI, saying that “MRI may add to the diagnosis of OA and should be incorporated into the [American College of Rheumatology] diagnostic criteria,” but in the same proposition, the working group also reiterated the role of x-ray, clinical, and laboratory parameters. Other propositions caution that “no single MRI finding is diagnostic of MRI,” and that “certain MRI changes in isolation … are not diagnostic of osteoarthritis.”

The working group's propositions included two MRI-based definitions of OA, for the tibiofemoral form and for the patellofemoral type.

In a recent talk on MRI and OA, Dr. Conaghan stressed the potential that MRI holds for early OA detection. “We need to develop an early OA culture,” similar to what has emerged for rheumatoid arthritis, he said speaking in May at the annual European Congress of Rheumatology in London. “In OA, we need a culture of early intervention” that would rely on early detection, most likely using MRI.

“Clinical features may suffice at present” for early OA detection, but MRI offers the best individualized option for assessing cartilage, bone features, and possibly the meniscus, he said. Soluble biomarkers may be more feasible” than MRI, but biomarkers need more development and for early detection are “not there yet.”

The sheer frequency of MRI lesions in OA patients may prove limiting. OA lesions appear more often on MRI than on x-rays. In five different reported series, the prevalence of cartilage defects visible by MRI in OA patients was 85%-98%, and the prevalence of osteophytes was 70%-100%, Dr. Conaghan noted. Often the MRI changes appear with no radio-graphic change visible. Other MRI changes that look like promising OA markers are bone marrow lesions and bone shape.

The OARSI Working Group defined tibiofemoral OA by MRI as either both items from group A, or one group A item and at least two from group B. The group A diagnostic features are definite osteophyte formation and full-thickness cartilage loss. The group B items are a subchondral bone marrow lesion or cyst that is not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative tear; partial-thickness cartilage loss; and bone attrition.

The working group's definition of patellofemoral OA requires both a definitive osteophyte and partial- or full-thickness cartilage loss.

Dr. Conaghan said that he had no relevant disclosures.

'We need a culture of early intervention' that would rely on early detection, most likely using MRI.

Source DR. CONAGHAN

Magnetic resonance imaging has an increasingly important role in early detection and diagnosis of osteoarthritis, although for now it remains one of several diagnostic tools that also include x-rays, clinical findings, and lab results.

Physicians who treat patients with osteoarthritis (OA) need further research results to better clarify the best use of MRI in early OA detection, said Dr. Philip Conaghan, professor of musculoskeletal medicine at the University of Leeds (England).

In June, Dr. Conaghan and his colleagues on the OA Imaging Working Group for the Osteoarthritis Research Society International (OARSI) issued 11 propositions on using MRI to define OA – propositions that the group said need formal testing “regarding their diagnostic performance before they are more widely used” (Osteoarthritis Cartilage 2011;19:963-9).

The working group clearly endorsed MRI, saying that “MRI may add to the diagnosis of OA and should be incorporated into the [American College of Rheumatology] diagnostic criteria,” but in the same proposition, the working group also reiterated the role of x-ray, clinical, and laboratory parameters. Other propositions caution that “no single MRI finding is diagnostic of MRI,” and that “certain MRI changes in isolation … are not diagnostic of osteoarthritis.”

The working group's propositions included two MRI-based definitions of OA, for the tibiofemoral form and for the patellofemoral type.

In a recent talk on MRI and OA, Dr. Conaghan stressed the potential that MRI holds for early OA detection. “We need to develop an early OA culture,” similar to what has emerged for rheumatoid arthritis, he said speaking in May at the annual European Congress of Rheumatology in London. “In OA, we need a culture of early intervention” that would rely on early detection, most likely using MRI.

“Clinical features may suffice at present” for early OA detection, but MRI offers the best individualized option for assessing cartilage, bone features, and possibly the meniscus, he said. Soluble biomarkers may be more feasible” than MRI, but biomarkers need more development and for early detection are “not there yet.”

The sheer frequency of MRI lesions in OA patients may prove limiting. OA lesions appear more often on MRI than on x-rays. In five different reported series, the prevalence of cartilage defects visible by MRI in OA patients was 85%-98%, and the prevalence of osteophytes was 70%-100%, Dr. Conaghan noted. Often the MRI changes appear with no radio-graphic change visible. Other MRI changes that look like promising OA markers are bone marrow lesions and bone shape.

The OARSI Working Group defined tibiofemoral OA by MRI as either both items from group A, or one group A item and at least two from group B. The group A diagnostic features are definite osteophyte formation and full-thickness cartilage loss. The group B items are a subchondral bone marrow lesion or cyst that is not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative tear; partial-thickness cartilage loss; and bone attrition.

The working group's definition of patellofemoral OA requires both a definitive osteophyte and partial- or full-thickness cartilage loss.

Dr. Conaghan said that he had no relevant disclosures.

'We need a culture of early intervention' that would rely on early detection, most likely using MRI.

Source DR. CONAGHAN

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Joint Distraction May Delay Knee Replacement : Device demonstrated 'intrinsic tissue structure repair in OA.'

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Joint Distraction May Delay Knee Replacement : Device demonstrated 'intrinsic tissue structure repair in OA.'

Major Finding: Joint distraction can induce tissue structure modification in knee osteoarthritis, as shown on radiography, MRI, and blood work, possibly delaying the need for endoprosthesis.

Data Source: An open, 1-year pilot study of 20 patients with tibiofemoral osteoarthritis who were treated surgically with joint distraction.

Disclosures: The authors had no relationships to disclose. The Dutch Arthritis Foundation provided financial support for this study.

Joint distraction can induce tissue structure modification in knee osteoarthritis, possibly reversing structural damage to cartilage tissue and delaying the need for knee replacement surgery

Endoprosthesis currently is the accepted method for treating pain caused by end-stage knee OA. However, the growing number of procedures carries a high price tag, and there is a higher risk of failure in patients aged younger than 65 years.

With that in mind, Dr. Femke Intema of the University Medical Center Utrecht (the Netherlands) and colleagues wanted to determine whether joint distraction could halt and possibly reverse joint degeneration in knee OA (Ann. Rheum. Dis. 2011;70:1441-6).

The study included 11 men and 9 women who had knee OA and in whom knee replacement surgery was indicated in 2006-2008. Patients were an average of 48 years old; 18 of them had predominant OA in the medial compartment; the remaining two had OA in the lateral compartment. Patients had a score of 60 mm or higher on the Visual Analogue Scale (VAS) of pain, as well as radiographic signs of joint damage, and primarily tibiofemoral OA.

Joint distraction was applied for 2 months via an external fixation frame. At the 1-year follow-up, researchers evaluated tissue structure modification according to the following:

Radiographic analysis. This showed that the mean joint space width (JSW) of the most affected compartment increased from 2.7 mm to 3.6 mm between baseline and 12 months, whereas the minimum JSW increased from 1 mm to 1.9 mm.

Quantitative MRI analysis. At 1 year, this showed an increase in the mean thickness of cartilage over total area of bone (ThCtAB) from 2.4 mm to 3 mm in the most affected compartment, and a decrease in mean percentage area of denuded bone (dABp) from 22% to 5%. The thickness of cartilage over area of bone covered with cartilage (ThCcAB), a secondary structural outcome parameter, showed a borderline increase from 2.9 mm to 3.1 mm.

Biomarker analysis on serum and urine samples. These showed an 11% decrease of CTXII (a collagen type II breakdown marker), and a 103% increase in PILANP/CTXII (a collage type II synthesis marker), between 6 and 12 months. These findings suggest a net increase in collagen synthesis, the researchers said.

The primary outcome parameter of this study was the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index questionnaire, which decreased from 55 points at baseline to 23 points at 1 year. In all, 18 of the 20 patients showed a greater-than-10% improvement, and 16 showed a greater-than-25% improvement. There were significant improvements in the individual components of the WOMAC index, namely pain, stiffness, and function.

One secondary measure, the VAS pain score, decreased from 73 mm at baseline to 31 mm at 1 year. Physical examination of the joint, which assessed crepitus, pain on palpation, pain with flexion, and joint effusion, showed improvement from 46% to 75%.

“This study is the first to demonstrate intrinsic tissue structure repair in OA,” the researchers said. “Historically, the regenerative capacity of cartilage has been questioned owing to the slow turnover rate of cartilage matrix, especially of collagen. However, this study shows that a significant amount of cartilage tissue is formed within 1 year after the distraction, demonstrating that under certain conditions, cartilage has regenerative capacity.”

There is uncertainty as to the underlying mechanism of the structural repair that was seen in this study. One possibility is that temporary distraction prevents mechanical stress on the cartilage, prevents further wear and tear, and allows tissue repair to begin, the researchers said.

For now, the researchers are unsure which patients may benefit from this procedure, as the study included only those patients who were younger than 50 years, had severe OA, and were likely candidates for joint replacement surgery. Referrals from peripheral hospitals may have led to selection bias, the researchers said.

Safety concerns exist as well. Two patients developed lung emboli and required hospitalization and anticoagulative treatment. Also, 17 patients developed single or multiple pin-tract infections, all of which were successfully treated with antibiotics.

Larger and longer trials in a variety of OA populations are needed to optimize treatment, to determine which patients would benefit the most and for the longest period of time, and to pay attention to reducing the number of complications, according to Dr. Intema and associates.

 

 

Knee distraction was applied for 2 months via an external fixation frame.

Source Courtesy Dr. Floris P.J.G. Lafeber

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Major Finding: Joint distraction can induce tissue structure modification in knee osteoarthritis, as shown on radiography, MRI, and blood work, possibly delaying the need for endoprosthesis.

Data Source: An open, 1-year pilot study of 20 patients with tibiofemoral osteoarthritis who were treated surgically with joint distraction.

Disclosures: The authors had no relationships to disclose. The Dutch Arthritis Foundation provided financial support for this study.

Joint distraction can induce tissue structure modification in knee osteoarthritis, possibly reversing structural damage to cartilage tissue and delaying the need for knee replacement surgery

Endoprosthesis currently is the accepted method for treating pain caused by end-stage knee OA. However, the growing number of procedures carries a high price tag, and there is a higher risk of failure in patients aged younger than 65 years.

With that in mind, Dr. Femke Intema of the University Medical Center Utrecht (the Netherlands) and colleagues wanted to determine whether joint distraction could halt and possibly reverse joint degeneration in knee OA (Ann. Rheum. Dis. 2011;70:1441-6).

The study included 11 men and 9 women who had knee OA and in whom knee replacement surgery was indicated in 2006-2008. Patients were an average of 48 years old; 18 of them had predominant OA in the medial compartment; the remaining two had OA in the lateral compartment. Patients had a score of 60 mm or higher on the Visual Analogue Scale (VAS) of pain, as well as radiographic signs of joint damage, and primarily tibiofemoral OA.

Joint distraction was applied for 2 months via an external fixation frame. At the 1-year follow-up, researchers evaluated tissue structure modification according to the following:

Radiographic analysis. This showed that the mean joint space width (JSW) of the most affected compartment increased from 2.7 mm to 3.6 mm between baseline and 12 months, whereas the minimum JSW increased from 1 mm to 1.9 mm.

Quantitative MRI analysis. At 1 year, this showed an increase in the mean thickness of cartilage over total area of bone (ThCtAB) from 2.4 mm to 3 mm in the most affected compartment, and a decrease in mean percentage area of denuded bone (dABp) from 22% to 5%. The thickness of cartilage over area of bone covered with cartilage (ThCcAB), a secondary structural outcome parameter, showed a borderline increase from 2.9 mm to 3.1 mm.

Biomarker analysis on serum and urine samples. These showed an 11% decrease of CTXII (a collagen type II breakdown marker), and a 103% increase in PILANP/CTXII (a collage type II synthesis marker), between 6 and 12 months. These findings suggest a net increase in collagen synthesis, the researchers said.

The primary outcome parameter of this study was the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index questionnaire, which decreased from 55 points at baseline to 23 points at 1 year. In all, 18 of the 20 patients showed a greater-than-10% improvement, and 16 showed a greater-than-25% improvement. There were significant improvements in the individual components of the WOMAC index, namely pain, stiffness, and function.

One secondary measure, the VAS pain score, decreased from 73 mm at baseline to 31 mm at 1 year. Physical examination of the joint, which assessed crepitus, pain on palpation, pain with flexion, and joint effusion, showed improvement from 46% to 75%.

“This study is the first to demonstrate intrinsic tissue structure repair in OA,” the researchers said. “Historically, the regenerative capacity of cartilage has been questioned owing to the slow turnover rate of cartilage matrix, especially of collagen. However, this study shows that a significant amount of cartilage tissue is formed within 1 year after the distraction, demonstrating that under certain conditions, cartilage has regenerative capacity.”

There is uncertainty as to the underlying mechanism of the structural repair that was seen in this study. One possibility is that temporary distraction prevents mechanical stress on the cartilage, prevents further wear and tear, and allows tissue repair to begin, the researchers said.

For now, the researchers are unsure which patients may benefit from this procedure, as the study included only those patients who were younger than 50 years, had severe OA, and were likely candidates for joint replacement surgery. Referrals from peripheral hospitals may have led to selection bias, the researchers said.

Safety concerns exist as well. Two patients developed lung emboli and required hospitalization and anticoagulative treatment. Also, 17 patients developed single or multiple pin-tract infections, all of which were successfully treated with antibiotics.

Larger and longer trials in a variety of OA populations are needed to optimize treatment, to determine which patients would benefit the most and for the longest period of time, and to pay attention to reducing the number of complications, according to Dr. Intema and associates.

 

 

Knee distraction was applied for 2 months via an external fixation frame.

Source Courtesy Dr. Floris P.J.G. Lafeber

Major Finding: Joint distraction can induce tissue structure modification in knee osteoarthritis, as shown on radiography, MRI, and blood work, possibly delaying the need for endoprosthesis.

Data Source: An open, 1-year pilot study of 20 patients with tibiofemoral osteoarthritis who were treated surgically with joint distraction.

Disclosures: The authors had no relationships to disclose. The Dutch Arthritis Foundation provided financial support for this study.

Joint distraction can induce tissue structure modification in knee osteoarthritis, possibly reversing structural damage to cartilage tissue and delaying the need for knee replacement surgery

Endoprosthesis currently is the accepted method for treating pain caused by end-stage knee OA. However, the growing number of procedures carries a high price tag, and there is a higher risk of failure in patients aged younger than 65 years.

With that in mind, Dr. Femke Intema of the University Medical Center Utrecht (the Netherlands) and colleagues wanted to determine whether joint distraction could halt and possibly reverse joint degeneration in knee OA (Ann. Rheum. Dis. 2011;70:1441-6).

The study included 11 men and 9 women who had knee OA and in whom knee replacement surgery was indicated in 2006-2008. Patients were an average of 48 years old; 18 of them had predominant OA in the medial compartment; the remaining two had OA in the lateral compartment. Patients had a score of 60 mm or higher on the Visual Analogue Scale (VAS) of pain, as well as radiographic signs of joint damage, and primarily tibiofemoral OA.

Joint distraction was applied for 2 months via an external fixation frame. At the 1-year follow-up, researchers evaluated tissue structure modification according to the following:

Radiographic analysis. This showed that the mean joint space width (JSW) of the most affected compartment increased from 2.7 mm to 3.6 mm between baseline and 12 months, whereas the minimum JSW increased from 1 mm to 1.9 mm.

Quantitative MRI analysis. At 1 year, this showed an increase in the mean thickness of cartilage over total area of bone (ThCtAB) from 2.4 mm to 3 mm in the most affected compartment, and a decrease in mean percentage area of denuded bone (dABp) from 22% to 5%. The thickness of cartilage over area of bone covered with cartilage (ThCcAB), a secondary structural outcome parameter, showed a borderline increase from 2.9 mm to 3.1 mm.

Biomarker analysis on serum and urine samples. These showed an 11% decrease of CTXII (a collagen type II breakdown marker), and a 103% increase in PILANP/CTXII (a collage type II synthesis marker), between 6 and 12 months. These findings suggest a net increase in collagen synthesis, the researchers said.

The primary outcome parameter of this study was the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index questionnaire, which decreased from 55 points at baseline to 23 points at 1 year. In all, 18 of the 20 patients showed a greater-than-10% improvement, and 16 showed a greater-than-25% improvement. There were significant improvements in the individual components of the WOMAC index, namely pain, stiffness, and function.

One secondary measure, the VAS pain score, decreased from 73 mm at baseline to 31 mm at 1 year. Physical examination of the joint, which assessed crepitus, pain on palpation, pain with flexion, and joint effusion, showed improvement from 46% to 75%.

“This study is the first to demonstrate intrinsic tissue structure repair in OA,” the researchers said. “Historically, the regenerative capacity of cartilage has been questioned owing to the slow turnover rate of cartilage matrix, especially of collagen. However, this study shows that a significant amount of cartilage tissue is formed within 1 year after the distraction, demonstrating that under certain conditions, cartilage has regenerative capacity.”

There is uncertainty as to the underlying mechanism of the structural repair that was seen in this study. One possibility is that temporary distraction prevents mechanical stress on the cartilage, prevents further wear and tear, and allows tissue repair to begin, the researchers said.

For now, the researchers are unsure which patients may benefit from this procedure, as the study included only those patients who were younger than 50 years, had severe OA, and were likely candidates for joint replacement surgery. Referrals from peripheral hospitals may have led to selection bias, the researchers said.

Safety concerns exist as well. Two patients developed lung emboli and required hospitalization and anticoagulative treatment. Also, 17 patients developed single or multiple pin-tract infections, all of which were successfully treated with antibiotics.

Larger and longer trials in a variety of OA populations are needed to optimize treatment, to determine which patients would benefit the most and for the longest period of time, and to pay attention to reducing the number of complications, according to Dr. Intema and associates.

 

 

Knee distraction was applied for 2 months via an external fixation frame.

Source Courtesy Dr. Floris P.J.G. Lafeber

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RA Treatment Did Not Reduce Use of Sick Leave

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RA Treatment Did Not Reduce Use of Sick Leave

Major Finding: Sick leave and disability pension in Sweden increased rapidly in patients with rheumatoid arthritis before the initiation of therapy, which halted but did not reverse this development.

Data Source: Data obtained from the Swedish Rheumatology Quality Register and the Social Insurance Office database.

Disclosures: The ARTIS study group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.

Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.

These findings suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may suggest the need for earlier intervention.

Lost productivity figures are among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients' ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.

To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) study group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).

First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007.

Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient's personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.

The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.

The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found.

Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.

The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).

The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.

“We made a series of important observations,” the researchers said. “One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start.” The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.

Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.

“Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development,” the researchers said.

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Major Finding: Sick leave and disability pension in Sweden increased rapidly in patients with rheumatoid arthritis before the initiation of therapy, which halted but did not reverse this development.

Data Source: Data obtained from the Swedish Rheumatology Quality Register and the Social Insurance Office database.

Disclosures: The ARTIS study group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.

Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.

These findings suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may suggest the need for earlier intervention.

Lost productivity figures are among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients' ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.

To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) study group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).

First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007.

Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient's personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.

The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.

The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found.

Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.

The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).

The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.

“We made a series of important observations,” the researchers said. “One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start.” The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.

Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.

“Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development,” the researchers said.

Major Finding: Sick leave and disability pension in Sweden increased rapidly in patients with rheumatoid arthritis before the initiation of therapy, which halted but did not reverse this development.

Data Source: Data obtained from the Swedish Rheumatology Quality Register and the Social Insurance Office database.

Disclosures: The ARTIS study group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.

Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.

These findings suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may suggest the need for earlier intervention.

Lost productivity figures are among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients' ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.

To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) study group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).

First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007.

Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient's personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.

The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.

The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found.

Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.

The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).

The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.

“We made a series of important observations,” the researchers said. “One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start.” The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.

Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.

“Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development,” the researchers said.

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Women More Likely to Have Hand Osteoarthritis

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Major Finding: The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Data Source: An analysis of 2,300 adults from the ongoing Framingham Osteoarthritis Study who had bilateral hand radiographs at baseline and at 9-year follow-up.

Disclosures: The Framingham OA Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University.

Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population.

All study participants had bilateral hand radio-graphs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radio-graphic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness.

Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white.

The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

“Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant),” the researchers wrote.

“The symmetrical joint affection indicates that 'wear and tear' alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested.”

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it “uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups,” they wrote.

“The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the U.S. population.

“The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult.

“It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression,” Dr. Haugen and her associates said.

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Major Finding: The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Data Source: An analysis of 2,300 adults from the ongoing Framingham Osteoarthritis Study who had bilateral hand radiographs at baseline and at 9-year follow-up.

Disclosures: The Framingham OA Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University.

Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population.

All study participants had bilateral hand radio-graphs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radio-graphic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness.

Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white.

The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

“Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant),” the researchers wrote.

“The symmetrical joint affection indicates that 'wear and tear' alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested.”

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it “uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups,” they wrote.

“The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the U.S. population.

“The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult.

“It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression,” Dr. Haugen and her associates said.

Major Finding: The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Data Source: An analysis of 2,300 adults from the ongoing Framingham Osteoarthritis Study who had bilateral hand radiographs at baseline and at 9-year follow-up.

Disclosures: The Framingham OA Study is supported by the National Institutes of Health. Dr. Haugen disclosed that she received grants from the South-Eastern Norway Regional Health Authority and a scholarship from OARSI. Another study investigator, Dr. Martin Englund, disclosed that he received funding support from Swedish Research Council and Lund (Sweden) University.

Hand osteoarthritis becomes more prevalent with advancing age and is more common in women than men, but not in all joint areas, results from a long-term analysis demonstrated.

Over 9 years of follow-up, more men than women developed metacarpal and wrist osteoarthritis (OA), yet more women than men developed erosive and symptomatic OA, according to a report by researchers led by Dr. Ida K. Haugen of the department of rheumatology at Diakonhjemmet Hospital, Oslo.

In what they describe as the first study of its kind, the researchers analyzed data from 2,300 adults who participated in the Framingham OA Study to determine the prevalence and course of radiographic, erosive, and symptomatic hand OA in the general population.

All study participants had bilateral hand radio-graphs at baseline and at 9-year follow-up (Ann. Rheum. Dis. 2011;70:1581-6).

Dr. Ida Haugen and her associates defined radio-graphic hand OA at the joint level as a Kellgren-Lawrence scale grade 2 or greater, erosive hand OA as a Kellgren-Lawrence grade 2 or greater plus erosion, and symptomatic hand OA as a Kellgren-Lawrence grade 2 or greater plus pain/aching/stiffness.

Study participants with one or more affected joint were classified as having hand OA.

The mean age of the study participants was 59 years, 57% were women, and 96% were white.

The age-standardized prevalence of hand OA was modestly higher in women compared with men (44% vs. 38%, respectively), but women had a significantly higher age-standardized prevalence of erosive OA (10% vs. 3%) and symptomatic OA (16% vs. 8%).

Over the 9 years of follow-up, the crude incidence was similar between women and men (35% vs. 34%, respectively), whereas 96% of women and 91% of men who had hand OA at baseline showed progression during follow-up.

The researchers also reported that metacarpophalangeal and wrist OA occurred more frequently and from a younger age in men, compared with women, and that development of erosive disease occurred more frequently in women, compared with men (17% vs. 10%, respectively).

“Consistent with previous studies, we found no clear evidence of higher hand OA incidence in the right hand (usually dominant),” the researchers wrote.

“The symmetrical joint affection indicates that 'wear and tear' alone is not sufficient to explain the pattern of hand OA, and neurogenic and hormonal influences have been suggested.”

They acknowledged certain limitations of the study, including the fact that participants were from a limited geographic area, which makes it “uncertain whether the results can be generalized to larger geographical areas or [nonwhite] groups,” they wrote.

“The offspring cohort [of the Framingham OA Study] was not randomly selected from the population. However, the participants were not chosen based on joint symptoms, and previous studies have indicated that the cohort is reasonably representative of the U.S. population.

“The mean time of follow-up was 9 years, and almost all participants showed progression, making discrimination between groups difficult.

“It is possible but unproven that reading of radiographs in known time sequence may lead to overestimation of progression,” Dr. Haugen and her associates said.

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Low Vitamin D Tied to Musculoskeletal Pain

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Major Finding: The prevalence of suboptimal vitamin D levels in a cohort of elderly patients with chronic musculoskeletal pain was significantly higher, at 70%, than the 32% observed in age-, sex-, and BMI-matched patients who were pain free.

Data Source: An observational study comparing the serum vitamin D levels of 265 community-dwelling adults with chronic musculoskeletal pain aged 65 and older with those of 200 pain-free matched controls.

Disclosures: Dr. Abou-Raya reported having no financial conflicts of interest to disclose.

Is vitamin D a neglected analgesic for chronic musculoskeletal pain? Dr. Suzan Abou-Raya, professor of geriatric medicine at the University of Alexandria in Egypt, thinks it could be and recommends that physicians consider oral supplementation for all pain patients. Dr. Abou-Raya based her opinion on a recent study in which she and her colleagues evaluated the association between vitamin D status and chronic musculoskeletal pain in a cohort of community-dwelling older adults.

The investigators compared the vitamin D status of 265 adults aged 65 years and older who presented to their institution for musculoskeletal pain management with that of 200 other adults who were free of chronic musculoskeletal pain. These controls were matched to the cases by age, sex, and body mass index, said Dr. Abou-Raya. Individuals with known vitamin D deficiency and calcium abnormality were excluded from the study, as were those with severe cognitive impairment or infectious, blood, hepatic, and renal disorders.

All of the participants in the study (conducted during the months of April through September to account for seasonal variation) were surveyd about sun exposure and nutritional intake to assess daily intake of vitamin D and calcium, Dr. Abou-Raya said. They underwent a comprehensive clinical examination, with pain assessed using the Brief Pain Inventory and Visual Analogue Scale.

“Chronic pain was defined as pain that was present in the previous month and for at least 3 months during the previous year, and it was assessed according to the site of pain, the overall severity of the pain, and interference with daily activities,” she said. Also, all of the patients completed a joint pain questionnaire to assess chronic musculoskeletal pain in the hands and wrists, shoulders, back, hips, knees, and feet, and they were directed to record daily pain in a diary.

Levels of pain were assessed at monthly intervals, as was physical performance using activities of daily living, grip strength, 6-minute walk distance, and the timed Get up and Go Test of mobility. Additionally, serum vitamin D was measured by Liaison immunoassay and levels between 10 and 30 ng/ml were classified as vitamin D insufficiency and levels lower than 10 ng/ml were classified as vitamin D deficiency, she noted.

In musculoskeletal patients, the mean 25-hydroxyvitamin D level was 18.4 ng/ml compared with 28.9 ng/ml in the control group, which represents a statistically significant difference, Dr. Abou-Raya reported. “The overall prevalence of suboptimal vitamin D levels among patients was 70% vs. 32% in the controls,” she said, noting that 41% of the chronic musculoskeletal pain patients and only 1% of the controls met the criteria for vitamin D deficiency.

After multivariate adjustment, “chronic, multisite, musculoskeletal pain was associated with lower levels of 25-hydroxy-vitamin D, and lower levels of vitamin D correlated with pain severity and poor physical performance,” Dr. Abou-Raya stated. Sun exposure in the chronic pain group was significantly lower, with 40% of pain patients reporting they received fewer than 15 minutes of sun exposure weekly versus 11% of the controls.

“The possibility of inadequate vitamin D should be considered in the differential diagnosis of chronic musculoskeletal pain sufferers,” she said at the annual European Congress of Rheumatology.

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Major Finding: The prevalence of suboptimal vitamin D levels in a cohort of elderly patients with chronic musculoskeletal pain was significantly higher, at 70%, than the 32% observed in age-, sex-, and BMI-matched patients who were pain free.

Data Source: An observational study comparing the serum vitamin D levels of 265 community-dwelling adults with chronic musculoskeletal pain aged 65 and older with those of 200 pain-free matched controls.

Disclosures: Dr. Abou-Raya reported having no financial conflicts of interest to disclose.

Is vitamin D a neglected analgesic for chronic musculoskeletal pain? Dr. Suzan Abou-Raya, professor of geriatric medicine at the University of Alexandria in Egypt, thinks it could be and recommends that physicians consider oral supplementation for all pain patients. Dr. Abou-Raya based her opinion on a recent study in which she and her colleagues evaluated the association between vitamin D status and chronic musculoskeletal pain in a cohort of community-dwelling older adults.

The investigators compared the vitamin D status of 265 adults aged 65 years and older who presented to their institution for musculoskeletal pain management with that of 200 other adults who were free of chronic musculoskeletal pain. These controls were matched to the cases by age, sex, and body mass index, said Dr. Abou-Raya. Individuals with known vitamin D deficiency and calcium abnormality were excluded from the study, as were those with severe cognitive impairment or infectious, blood, hepatic, and renal disorders.

All of the participants in the study (conducted during the months of April through September to account for seasonal variation) were surveyd about sun exposure and nutritional intake to assess daily intake of vitamin D and calcium, Dr. Abou-Raya said. They underwent a comprehensive clinical examination, with pain assessed using the Brief Pain Inventory and Visual Analogue Scale.

“Chronic pain was defined as pain that was present in the previous month and for at least 3 months during the previous year, and it was assessed according to the site of pain, the overall severity of the pain, and interference with daily activities,” she said. Also, all of the patients completed a joint pain questionnaire to assess chronic musculoskeletal pain in the hands and wrists, shoulders, back, hips, knees, and feet, and they were directed to record daily pain in a diary.

Levels of pain were assessed at monthly intervals, as was physical performance using activities of daily living, grip strength, 6-minute walk distance, and the timed Get up and Go Test of mobility. Additionally, serum vitamin D was measured by Liaison immunoassay and levels between 10 and 30 ng/ml were classified as vitamin D insufficiency and levels lower than 10 ng/ml were classified as vitamin D deficiency, she noted.

In musculoskeletal patients, the mean 25-hydroxyvitamin D level was 18.4 ng/ml compared with 28.9 ng/ml in the control group, which represents a statistically significant difference, Dr. Abou-Raya reported. “The overall prevalence of suboptimal vitamin D levels among patients was 70% vs. 32% in the controls,” she said, noting that 41% of the chronic musculoskeletal pain patients and only 1% of the controls met the criteria for vitamin D deficiency.

After multivariate adjustment, “chronic, multisite, musculoskeletal pain was associated with lower levels of 25-hydroxy-vitamin D, and lower levels of vitamin D correlated with pain severity and poor physical performance,” Dr. Abou-Raya stated. Sun exposure in the chronic pain group was significantly lower, with 40% of pain patients reporting they received fewer than 15 minutes of sun exposure weekly versus 11% of the controls.

“The possibility of inadequate vitamin D should be considered in the differential diagnosis of chronic musculoskeletal pain sufferers,” she said at the annual European Congress of Rheumatology.

Major Finding: The prevalence of suboptimal vitamin D levels in a cohort of elderly patients with chronic musculoskeletal pain was significantly higher, at 70%, than the 32% observed in age-, sex-, and BMI-matched patients who were pain free.

Data Source: An observational study comparing the serum vitamin D levels of 265 community-dwelling adults with chronic musculoskeletal pain aged 65 and older with those of 200 pain-free matched controls.

Disclosures: Dr. Abou-Raya reported having no financial conflicts of interest to disclose.

Is vitamin D a neglected analgesic for chronic musculoskeletal pain? Dr. Suzan Abou-Raya, professor of geriatric medicine at the University of Alexandria in Egypt, thinks it could be and recommends that physicians consider oral supplementation for all pain patients. Dr. Abou-Raya based her opinion on a recent study in which she and her colleagues evaluated the association between vitamin D status and chronic musculoskeletal pain in a cohort of community-dwelling older adults.

The investigators compared the vitamin D status of 265 adults aged 65 years and older who presented to their institution for musculoskeletal pain management with that of 200 other adults who were free of chronic musculoskeletal pain. These controls were matched to the cases by age, sex, and body mass index, said Dr. Abou-Raya. Individuals with known vitamin D deficiency and calcium abnormality were excluded from the study, as were those with severe cognitive impairment or infectious, blood, hepatic, and renal disorders.

All of the participants in the study (conducted during the months of April through September to account for seasonal variation) were surveyd about sun exposure and nutritional intake to assess daily intake of vitamin D and calcium, Dr. Abou-Raya said. They underwent a comprehensive clinical examination, with pain assessed using the Brief Pain Inventory and Visual Analogue Scale.

“Chronic pain was defined as pain that was present in the previous month and for at least 3 months during the previous year, and it was assessed according to the site of pain, the overall severity of the pain, and interference with daily activities,” she said. Also, all of the patients completed a joint pain questionnaire to assess chronic musculoskeletal pain in the hands and wrists, shoulders, back, hips, knees, and feet, and they were directed to record daily pain in a diary.

Levels of pain were assessed at monthly intervals, as was physical performance using activities of daily living, grip strength, 6-minute walk distance, and the timed Get up and Go Test of mobility. Additionally, serum vitamin D was measured by Liaison immunoassay and levels between 10 and 30 ng/ml were classified as vitamin D insufficiency and levels lower than 10 ng/ml were classified as vitamin D deficiency, she noted.

In musculoskeletal patients, the mean 25-hydroxyvitamin D level was 18.4 ng/ml compared with 28.9 ng/ml in the control group, which represents a statistically significant difference, Dr. Abou-Raya reported. “The overall prevalence of suboptimal vitamin D levels among patients was 70% vs. 32% in the controls,” she said, noting that 41% of the chronic musculoskeletal pain patients and only 1% of the controls met the criteria for vitamin D deficiency.

After multivariate adjustment, “chronic, multisite, musculoskeletal pain was associated with lower levels of 25-hydroxy-vitamin D, and lower levels of vitamin D correlated with pain severity and poor physical performance,” Dr. Abou-Raya stated. Sun exposure in the chronic pain group was significantly lower, with 40% of pain patients reporting they received fewer than 15 minutes of sun exposure weekly versus 11% of the controls.

“The possibility of inadequate vitamin D should be considered in the differential diagnosis of chronic musculoskeletal pain sufferers,” she said at the annual European Congress of Rheumatology.

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