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Psoriatic Arthritis: Evidence Lacking for Widespread Methotrexate Use
SAN FRANCISCO – Methotrexate is not a disease-modifying antirheumatic drug in psoriatic arthritis, despite how well it works in psoriasis, according to Dr. Christopher T. Ritchlin.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence. There have been only two published double-blind, randomized, controlled trials of methotrexate in PsA done over the last 20 years, and both were underpowered and used a low dose of methotrexate (10 mg/week), said Dr. Ritchlin, professor of medicine and director of the clinical immunology research center at the University of Rochester (N.Y.).
A still-unpublished study that was presented at the annual meeting of the American College of Rheumatology in 2010 showed that methotrexate was not more effective than placebo in PsA (Arthritis Rheum. 2010:62 [suppl.]:S277, abstract 664). The study involved 221 patients who were given 15 mg/week of methotrexate or placebo for 6 months. About 65% of subjects in each group dropped out. The primary outcome measure was the psoriatic arthritis response criteria (PsARC), which most rheumatologists do not think is a good outcome measure, Dr. Ritchlin said at the Perspectives in Rheumatic Diseases 2011 meeting.
At the end of 3 and 6 months of the study, there were no differences between methotrexate and placebo on the PsARC, the ACR 20 (the American College of Rheumatology scale based on a 20% improvement in certain parameters), the DAS28 (Disease Activity Score based on a 28-joint count), a sensitive joint count, a tender joint count, and the C-reactive protein level/erythrocyte sedimentation rates. Only the patient and physician global scores and the skin score showed significant improvement in the methotrexate group.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence.
Another unpublished study, conducted in the former Soviet Union and presented at the ARC’s annual meeting in 2009, showed the opposite. The researchers compared infliximab vs. methotrexate in methotrexate-naive patients. The dosage used was 15-20 mg/week. They found that 66% of the patients achieved an ACR 20 improvement on methotrexate alone, as did 86% of those on methotrexate plus infliximab. Remissions according to the DAS28 were reported in 30% of those on methotrexate and in 69% of those on combination therapy.
Although it may be possible to find methotrexate-naive patients in the former Soviet Union, such patients are much less likely to walk into their rheumatologist’s office in the West.
Indirect data supporting the inefficacy of methotrexate come from NOR-DMARD. These data show that 6 months of treatment with a tumor necrosis factor inhibitor (146 patients) had significantly greater beneficial effects on patients with PsA than did methotrexate (356 patients) (Ann. Rheum. Dis. 2007;66:1038-42).
The propensity toward liver disease is another reason not to use methotrexate in patients with PsA, said Dr. Ritchlin at the meeting, which was sponsored by Skin Disease Education Foundation. Methotrexate is hepatotoxic. Data on the findings of 169 liver biopsies that were done on 71 patients with psoriasis showed that methotrexate significantly increased the risk for stage 3 or 4 fibrosis. The risk was highest in obese patients or those with diabetes (J. Hepatol. 2007;46:1111-8).
These findings serve to support "my own bias that this is due to their fatty livers," which have developed as a consequence of their obesity, a common comorbidity in PsA, he said. Another cause of fatty liver in this population may be the metabolic syndrome that often develops in patients with psoriasis.
Dr. Ritchlin reported financial relationships with Abbott, Amgen, Centocor, Genentech, Targacept, UCB, and Wyeth. SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – Methotrexate is not a disease-modifying antirheumatic drug in psoriatic arthritis, despite how well it works in psoriasis, according to Dr. Christopher T. Ritchlin.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence. There have been only two published double-blind, randomized, controlled trials of methotrexate in PsA done over the last 20 years, and both were underpowered and used a low dose of methotrexate (10 mg/week), said Dr. Ritchlin, professor of medicine and director of the clinical immunology research center at the University of Rochester (N.Y.).
A still-unpublished study that was presented at the annual meeting of the American College of Rheumatology in 2010 showed that methotrexate was not more effective than placebo in PsA (Arthritis Rheum. 2010:62 [suppl.]:S277, abstract 664). The study involved 221 patients who were given 15 mg/week of methotrexate or placebo for 6 months. About 65% of subjects in each group dropped out. The primary outcome measure was the psoriatic arthritis response criteria (PsARC), which most rheumatologists do not think is a good outcome measure, Dr. Ritchlin said at the Perspectives in Rheumatic Diseases 2011 meeting.
At the end of 3 and 6 months of the study, there were no differences between methotrexate and placebo on the PsARC, the ACR 20 (the American College of Rheumatology scale based on a 20% improvement in certain parameters), the DAS28 (Disease Activity Score based on a 28-joint count), a sensitive joint count, a tender joint count, and the C-reactive protein level/erythrocyte sedimentation rates. Only the patient and physician global scores and the skin score showed significant improvement in the methotrexate group.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence.
Another unpublished study, conducted in the former Soviet Union and presented at the ARC’s annual meeting in 2009, showed the opposite. The researchers compared infliximab vs. methotrexate in methotrexate-naive patients. The dosage used was 15-20 mg/week. They found that 66% of the patients achieved an ACR 20 improvement on methotrexate alone, as did 86% of those on methotrexate plus infliximab. Remissions according to the DAS28 were reported in 30% of those on methotrexate and in 69% of those on combination therapy.
Although it may be possible to find methotrexate-naive patients in the former Soviet Union, such patients are much less likely to walk into their rheumatologist’s office in the West.
Indirect data supporting the inefficacy of methotrexate come from NOR-DMARD. These data show that 6 months of treatment with a tumor necrosis factor inhibitor (146 patients) had significantly greater beneficial effects on patients with PsA than did methotrexate (356 patients) (Ann. Rheum. Dis. 2007;66:1038-42).
The propensity toward liver disease is another reason not to use methotrexate in patients with PsA, said Dr. Ritchlin at the meeting, which was sponsored by Skin Disease Education Foundation. Methotrexate is hepatotoxic. Data on the findings of 169 liver biopsies that were done on 71 patients with psoriasis showed that methotrexate significantly increased the risk for stage 3 or 4 fibrosis. The risk was highest in obese patients or those with diabetes (J. Hepatol. 2007;46:1111-8).
These findings serve to support "my own bias that this is due to their fatty livers," which have developed as a consequence of their obesity, a common comorbidity in PsA, he said. Another cause of fatty liver in this population may be the metabolic syndrome that often develops in patients with psoriasis.
Dr. Ritchlin reported financial relationships with Abbott, Amgen, Centocor, Genentech, Targacept, UCB, and Wyeth. SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – Methotrexate is not a disease-modifying antirheumatic drug in psoriatic arthritis, despite how well it works in psoriasis, according to Dr. Christopher T. Ritchlin.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence. There have been only two published double-blind, randomized, controlled trials of methotrexate in PsA done over the last 20 years, and both were underpowered and used a low dose of methotrexate (10 mg/week), said Dr. Ritchlin, professor of medicine and director of the clinical immunology research center at the University of Rochester (N.Y.).
A still-unpublished study that was presented at the annual meeting of the American College of Rheumatology in 2010 showed that methotrexate was not more effective than placebo in PsA (Arthritis Rheum. 2010:62 [suppl.]:S277, abstract 664). The study involved 221 patients who were given 15 mg/week of methotrexate or placebo for 6 months. About 65% of subjects in each group dropped out. The primary outcome measure was the psoriatic arthritis response criteria (PsARC), which most rheumatologists do not think is a good outcome measure, Dr. Ritchlin said at the Perspectives in Rheumatic Diseases 2011 meeting.
At the end of 3 and 6 months of the study, there were no differences between methotrexate and placebo on the PsARC, the ACR 20 (the American College of Rheumatology scale based on a 20% improvement in certain parameters), the DAS28 (Disease Activity Score based on a 28-joint count), a sensitive joint count, a tender joint count, and the C-reactive protein level/erythrocyte sedimentation rates. Only the patient and physician global scores and the skin score showed significant improvement in the methotrexate group.
Methotrexate is the most widely used drug in the world for psoriatic arthritis (PsA), based on almost no supporting evidence.
Another unpublished study, conducted in the former Soviet Union and presented at the ARC’s annual meeting in 2009, showed the opposite. The researchers compared infliximab vs. methotrexate in methotrexate-naive patients. The dosage used was 15-20 mg/week. They found that 66% of the patients achieved an ACR 20 improvement on methotrexate alone, as did 86% of those on methotrexate plus infliximab. Remissions according to the DAS28 were reported in 30% of those on methotrexate and in 69% of those on combination therapy.
Although it may be possible to find methotrexate-naive patients in the former Soviet Union, such patients are much less likely to walk into their rheumatologist’s office in the West.
Indirect data supporting the inefficacy of methotrexate come from NOR-DMARD. These data show that 6 months of treatment with a tumor necrosis factor inhibitor (146 patients) had significantly greater beneficial effects on patients with PsA than did methotrexate (356 patients) (Ann. Rheum. Dis. 2007;66:1038-42).
The propensity toward liver disease is another reason not to use methotrexate in patients with PsA, said Dr. Ritchlin at the meeting, which was sponsored by Skin Disease Education Foundation. Methotrexate is hepatotoxic. Data on the findings of 169 liver biopsies that were done on 71 patients with psoriasis showed that methotrexate significantly increased the risk for stage 3 or 4 fibrosis. The risk was highest in obese patients or those with diabetes (J. Hepatol. 2007;46:1111-8).
These findings serve to support "my own bias that this is due to their fatty livers," which have developed as a consequence of their obesity, a common comorbidity in PsA, he said. Another cause of fatty liver in this population may be the metabolic syndrome that often develops in patients with psoriasis.
Dr. Ritchlin reported financial relationships with Abbott, Amgen, Centocor, Genentech, Targacept, UCB, and Wyeth. SDEF and this news organization are owned by Elsevier.
EXPERT ANALYSIS FROM THE PERSPECTIVES IN RHEUMATIC DISEASES 2011
RA: Atypical Heart Disease Presentation Can Be Fatal
SAN FRANCISCO – The atypical presentation of cardiovascular disease in patients with rheumatoid arthritis often masks its presence until the patient dies suddenly, according to Dr. Vibeke Strand.
The mortality in patients with RA is twice that of the normal population, with the average life span being reduced by 15-18 years in RA, which is comparable to the early mortality seen in patients with diabetes. Cardiovascular disease (CVD) explains almost all of the excess mortality seen in patients with RA, said Dr. Strand of the division of immunology and rheumatology at Stanford (Calif.) University.
CVD risk factors are atypical in RA patients. They are less likely to be obese or to have hypertension, hyperlipidemia, or diabetes (J. Rheumatol. 2011;38:29-35). Heart failure is more common in the RA population, especially in rheumatoid factor (RF)-positive patients. However despite their heart failure, their ejection fraction often remains normal.
Patients’ body mass index tends to be low, suggesting that their heart failure may result from reduced myocardial mass rather than from hypertrophy. Those with a BMI less than 20 kg/m2 have a significantly decreased survival, she said at the Perspectives in Rheumatic Diseases 2011 meeting.
Because their CVD presentation is atypical, RA patients tend to get recognized later in the course of their heart disease and to be treated less aggressively. RA patients are less likely than those without the disease to undergo revascularization or receive cardiovascular medications after an MI.
Until recently, rheumatologists have been unable to lessen early mortality among RA patients. However, data from a study of 3,862 RA patients diagnosed with RA either before 1970, between 1970 and 1980, or after 1990 showed a drop in excess mortality among the 1,240 patients diagnosed after 1995. The researchers attributed the prolonged survival to the use of methotrexate (Lancet 2002;359:1173-7; Circulation 2004;110:1774-9).
With the advent of the biologics era, particularly the widespread use of tumor necrosis factor (TNF) inhibitors, rheumatologists have been wondering whether the anti-inflammatory properties of these agents would lower CVD mortality among RA patients.
Data presented at the 2005 Congress of the European League Against Rheumatism (EULAR) (abstract OP0095) showed that use of TNF inhibitors lowers the hazard ratio of all-cause mortality to 0.72 among RA patients. These findings were based on 63,811 patient-years of follow-up of 19,580 RA patients, among whom there were 1,129 deaths. Use of methotrexate was associated with an HR of 0.82. Prednisone increased the risk to an HR of 1.60, which is consistent with the well-documented risk of CVD associated with the use of even small doses of this agent, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Standard risk scores such as the Framingham score underestimate the risk for heart disease in an RA population. The underestimation is clear in the results of a study that compared mortality risk as calculated by the Framingham score with actual events in 341 women with RA aged 30-74 years and 150 men with RA aged 30-74 years. According to the Framingham score, the 10-year CVD risk for the women was 4.6%. In fact, it was 11.1%. For the men, the Framingham risk was 12%. The actual cardiovascular risk was 25.8% (Arthritis Rheum. 2009;60:S264).
The excess CVD risk persists even after traditional risk factors seen in normal populations are controlled for. The biggest remaining risk is the burden of inflammation. There are increased levels of TNF-alpha and interleukin-6 in the serum, myocardium, and synovitis of RA, according to Dr. Strand.
Recommendations on limiting the increased risk for CVD issued by EULAR (Ann. Rheum. Dis. 2010;69:325-31) suggest modifying the risk score by multiplying it by 1.5 when the patient has two of the three following signs of severe disease: RA duration of more than 10 years; rheumatoid factor and anti-CCP antibody positivity; and/or extra-articular disease manifestations.
The following steps should be taken in such patients:
• Monitor total cholesterol/high-density lipoprotein levels.
• Manage appropriate treatment with statins, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers.
• Prescribe steroids at the lowest possible dose, if at all.
• Urge caution regarding the use of nonsteroidal anti-inflammatory drugs and COX-2 inhibitors.
• Urge patients to stop smoking.
Dr. Strand disclosed that she has financial relationships with many companies that make treatments for RA.
SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – The atypical presentation of cardiovascular disease in patients with rheumatoid arthritis often masks its presence until the patient dies suddenly, according to Dr. Vibeke Strand.
The mortality in patients with RA is twice that of the normal population, with the average life span being reduced by 15-18 years in RA, which is comparable to the early mortality seen in patients with diabetes. Cardiovascular disease (CVD) explains almost all of the excess mortality seen in patients with RA, said Dr. Strand of the division of immunology and rheumatology at Stanford (Calif.) University.
CVD risk factors are atypical in RA patients. They are less likely to be obese or to have hypertension, hyperlipidemia, or diabetes (J. Rheumatol. 2011;38:29-35). Heart failure is more common in the RA population, especially in rheumatoid factor (RF)-positive patients. However despite their heart failure, their ejection fraction often remains normal.
Patients’ body mass index tends to be low, suggesting that their heart failure may result from reduced myocardial mass rather than from hypertrophy. Those with a BMI less than 20 kg/m2 have a significantly decreased survival, she said at the Perspectives in Rheumatic Diseases 2011 meeting.
Because their CVD presentation is atypical, RA patients tend to get recognized later in the course of their heart disease and to be treated less aggressively. RA patients are less likely than those without the disease to undergo revascularization or receive cardiovascular medications after an MI.
Until recently, rheumatologists have been unable to lessen early mortality among RA patients. However, data from a study of 3,862 RA patients diagnosed with RA either before 1970, between 1970 and 1980, or after 1990 showed a drop in excess mortality among the 1,240 patients diagnosed after 1995. The researchers attributed the prolonged survival to the use of methotrexate (Lancet 2002;359:1173-7; Circulation 2004;110:1774-9).
With the advent of the biologics era, particularly the widespread use of tumor necrosis factor (TNF) inhibitors, rheumatologists have been wondering whether the anti-inflammatory properties of these agents would lower CVD mortality among RA patients.
Data presented at the 2005 Congress of the European League Against Rheumatism (EULAR) (abstract OP0095) showed that use of TNF inhibitors lowers the hazard ratio of all-cause mortality to 0.72 among RA patients. These findings were based on 63,811 patient-years of follow-up of 19,580 RA patients, among whom there were 1,129 deaths. Use of methotrexate was associated with an HR of 0.82. Prednisone increased the risk to an HR of 1.60, which is consistent with the well-documented risk of CVD associated with the use of even small doses of this agent, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Standard risk scores such as the Framingham score underestimate the risk for heart disease in an RA population. The underestimation is clear in the results of a study that compared mortality risk as calculated by the Framingham score with actual events in 341 women with RA aged 30-74 years and 150 men with RA aged 30-74 years. According to the Framingham score, the 10-year CVD risk for the women was 4.6%. In fact, it was 11.1%. For the men, the Framingham risk was 12%. The actual cardiovascular risk was 25.8% (Arthritis Rheum. 2009;60:S264).
The excess CVD risk persists even after traditional risk factors seen in normal populations are controlled for. The biggest remaining risk is the burden of inflammation. There are increased levels of TNF-alpha and interleukin-6 in the serum, myocardium, and synovitis of RA, according to Dr. Strand.
Recommendations on limiting the increased risk for CVD issued by EULAR (Ann. Rheum. Dis. 2010;69:325-31) suggest modifying the risk score by multiplying it by 1.5 when the patient has two of the three following signs of severe disease: RA duration of more than 10 years; rheumatoid factor and anti-CCP antibody positivity; and/or extra-articular disease manifestations.
The following steps should be taken in such patients:
• Monitor total cholesterol/high-density lipoprotein levels.
• Manage appropriate treatment with statins, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers.
• Prescribe steroids at the lowest possible dose, if at all.
• Urge caution regarding the use of nonsteroidal anti-inflammatory drugs and COX-2 inhibitors.
• Urge patients to stop smoking.
Dr. Strand disclosed that she has financial relationships with many companies that make treatments for RA.
SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – The atypical presentation of cardiovascular disease in patients with rheumatoid arthritis often masks its presence until the patient dies suddenly, according to Dr. Vibeke Strand.
The mortality in patients with RA is twice that of the normal population, with the average life span being reduced by 15-18 years in RA, which is comparable to the early mortality seen in patients with diabetes. Cardiovascular disease (CVD) explains almost all of the excess mortality seen in patients with RA, said Dr. Strand of the division of immunology and rheumatology at Stanford (Calif.) University.
CVD risk factors are atypical in RA patients. They are less likely to be obese or to have hypertension, hyperlipidemia, or diabetes (J. Rheumatol. 2011;38:29-35). Heart failure is more common in the RA population, especially in rheumatoid factor (RF)-positive patients. However despite their heart failure, their ejection fraction often remains normal.
Patients’ body mass index tends to be low, suggesting that their heart failure may result from reduced myocardial mass rather than from hypertrophy. Those with a BMI less than 20 kg/m2 have a significantly decreased survival, she said at the Perspectives in Rheumatic Diseases 2011 meeting.
Because their CVD presentation is atypical, RA patients tend to get recognized later in the course of their heart disease and to be treated less aggressively. RA patients are less likely than those without the disease to undergo revascularization or receive cardiovascular medications after an MI.
Until recently, rheumatologists have been unable to lessen early mortality among RA patients. However, data from a study of 3,862 RA patients diagnosed with RA either before 1970, between 1970 and 1980, or after 1990 showed a drop in excess mortality among the 1,240 patients diagnosed after 1995. The researchers attributed the prolonged survival to the use of methotrexate (Lancet 2002;359:1173-7; Circulation 2004;110:1774-9).
With the advent of the biologics era, particularly the widespread use of tumor necrosis factor (TNF) inhibitors, rheumatologists have been wondering whether the anti-inflammatory properties of these agents would lower CVD mortality among RA patients.
Data presented at the 2005 Congress of the European League Against Rheumatism (EULAR) (abstract OP0095) showed that use of TNF inhibitors lowers the hazard ratio of all-cause mortality to 0.72 among RA patients. These findings were based on 63,811 patient-years of follow-up of 19,580 RA patients, among whom there were 1,129 deaths. Use of methotrexate was associated with an HR of 0.82. Prednisone increased the risk to an HR of 1.60, which is consistent with the well-documented risk of CVD associated with the use of even small doses of this agent, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Standard risk scores such as the Framingham score underestimate the risk for heart disease in an RA population. The underestimation is clear in the results of a study that compared mortality risk as calculated by the Framingham score with actual events in 341 women with RA aged 30-74 years and 150 men with RA aged 30-74 years. According to the Framingham score, the 10-year CVD risk for the women was 4.6%. In fact, it was 11.1%. For the men, the Framingham risk was 12%. The actual cardiovascular risk was 25.8% (Arthritis Rheum. 2009;60:S264).
The excess CVD risk persists even after traditional risk factors seen in normal populations are controlled for. The biggest remaining risk is the burden of inflammation. There are increased levels of TNF-alpha and interleukin-6 in the serum, myocardium, and synovitis of RA, according to Dr. Strand.
Recommendations on limiting the increased risk for CVD issued by EULAR (Ann. Rheum. Dis. 2010;69:325-31) suggest modifying the risk score by multiplying it by 1.5 when the patient has two of the three following signs of severe disease: RA duration of more than 10 years; rheumatoid factor and anti-CCP antibody positivity; and/or extra-articular disease manifestations.
The following steps should be taken in such patients:
• Monitor total cholesterol/high-density lipoprotein levels.
• Manage appropriate treatment with statins, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers.
• Prescribe steroids at the lowest possible dose, if at all.
• Urge caution regarding the use of nonsteroidal anti-inflammatory drugs and COX-2 inhibitors.
• Urge patients to stop smoking.
Dr. Strand disclosed that she has financial relationships with many companies that make treatments for RA.
SDEF and this news organization are owned by Elsevier.
EXPERT ANALYSIS FROM PERSPECTIVES IN RHEUMATIC DISEASES 2011
Biologics Can Change the Face of RA
SAN FRANCISCO – Rheumatologists can prescribe drugs that can not only drive rheumatoid arthritis into remission but can also achieve some repair to the joints damaged by inflammation, according to Dr. Marc D. Cohen.
"In rheumatology, remission can never mean no disease. It just means not very much disease," said Dr. Cohen, emeritus professor of medicine at the Mayo Clinic, Rochester, Minn., and acting chief and professor of medicine at National Jewish Medical and Research Center in Denver.
"Rheumatologists need to be better sellers of what we can do. If you are not interested in changing the face of this disease, what are you doing?" he asked at the Perspectives in Rheumatic Diseases 2011 meeting.
In a review of the data on the efficacy of various biologic drugs in rheumatoid arthritis (RA), Dr. Cohen pointed out that, until the advent of biologics, there were no good trial data on the efficacy of methotrexate in RA. "The biologics are the best thing that ever happened to methotrexate, believe me," he said.
The study that put methotrexate on the map was the SWEFOT, in which investigators put all patients with RA on a trial of methotrexate before randomizing them to either triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine or to methotrexate plus a tumor necrosis factor inhibitor (TNFi). The findings from the methotrexate-monotherapy portion of the trial showed that 30% of the patients improved on methotrexate alone (Lancet 2009;374:459-66).
Because of these findings, all patients get a trial of methotrexate first, as quickly as possible, ramping up the dose over 1-2 months, to see what happens. What may get overlooked is the investigators’ note that, while a subset of patients experience clinical benefit from methotrexate monotherapy, radiographic disease progression continues despite methotrexate making the patients feel better.
There is no way to predict which 30% may respond clinically to methotrexate. That is one reason why one may want to rush through ramping up the dose.
Commonly, the next step in treating RA is to apply triple therapy. Further findings from the SWEFOT trial of 487 patients with RA symptoms of less than 1 year’s duration showed that clinically at 2 years the two treatment groups were the same in terms of Disease Activity Score (DAS). However, patients given triple therapy had more radiographic progression than did those given a TNFi plus methotrexate.
"Is that important to your patient? I am not sure. The problem is that we have no way to measure that. We need a point system. If you have RA in your right big toe and you are a piano player that is probably not as bad as having wrist disease. Maybe we should weight them."
The bottom line is that the addition of a TNFi to the treatment regimen of someone who did not respond completely to methotrexate will improve the clinical and radiologic response in two to three times the number of patients (Lancet 2007;370:1861-74).
This combination approach does not capture everyone.
This is part of the motivation behind the push for primary care physicians to recognize RA early and get the patients to the rheumatologists for biologic therapy early. When the biologics are given aggressively within the first 6 months of the disease, "we may be able to reset the disease, turn it off," he said.
In some cases, x-rays show repair of the joint damage when biologics are given early enough, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Dr. Paul Emery, professor of rheumatology and head of the academic unit of musculoskeletal medicine at the University of Leeds (England), presented data at the 2011 EULAR Congress showing that after patients achieved remission with methotrexate and a biologic, they could be maintained on methotrexate. This approach has the advantage of maintaining remission with a less-costly drug that also poses fewer potentially adverse effects than a biologic agent. "We do not know the right combination initially, but it is being examined," said Dr. Cohen.
SDEF and this news organization are owned by Elsevier.
Dr. Cohen reported having no relevant conflicts of interest to disclose.
SAN FRANCISCO – Rheumatologists can prescribe drugs that can not only drive rheumatoid arthritis into remission but can also achieve some repair to the joints damaged by inflammation, according to Dr. Marc D. Cohen.
"In rheumatology, remission can never mean no disease. It just means not very much disease," said Dr. Cohen, emeritus professor of medicine at the Mayo Clinic, Rochester, Minn., and acting chief and professor of medicine at National Jewish Medical and Research Center in Denver.
"Rheumatologists need to be better sellers of what we can do. If you are not interested in changing the face of this disease, what are you doing?" he asked at the Perspectives in Rheumatic Diseases 2011 meeting.
In a review of the data on the efficacy of various biologic drugs in rheumatoid arthritis (RA), Dr. Cohen pointed out that, until the advent of biologics, there were no good trial data on the efficacy of methotrexate in RA. "The biologics are the best thing that ever happened to methotrexate, believe me," he said.
The study that put methotrexate on the map was the SWEFOT, in which investigators put all patients with RA on a trial of methotrexate before randomizing them to either triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine or to methotrexate plus a tumor necrosis factor inhibitor (TNFi). The findings from the methotrexate-monotherapy portion of the trial showed that 30% of the patients improved on methotrexate alone (Lancet 2009;374:459-66).
Because of these findings, all patients get a trial of methotrexate first, as quickly as possible, ramping up the dose over 1-2 months, to see what happens. What may get overlooked is the investigators’ note that, while a subset of patients experience clinical benefit from methotrexate monotherapy, radiographic disease progression continues despite methotrexate making the patients feel better.
There is no way to predict which 30% may respond clinically to methotrexate. That is one reason why one may want to rush through ramping up the dose.
Commonly, the next step in treating RA is to apply triple therapy. Further findings from the SWEFOT trial of 487 patients with RA symptoms of less than 1 year’s duration showed that clinically at 2 years the two treatment groups were the same in terms of Disease Activity Score (DAS). However, patients given triple therapy had more radiographic progression than did those given a TNFi plus methotrexate.
"Is that important to your patient? I am not sure. The problem is that we have no way to measure that. We need a point system. If you have RA in your right big toe and you are a piano player that is probably not as bad as having wrist disease. Maybe we should weight them."
The bottom line is that the addition of a TNFi to the treatment regimen of someone who did not respond completely to methotrexate will improve the clinical and radiologic response in two to three times the number of patients (Lancet 2007;370:1861-74).
This combination approach does not capture everyone.
This is part of the motivation behind the push for primary care physicians to recognize RA early and get the patients to the rheumatologists for biologic therapy early. When the biologics are given aggressively within the first 6 months of the disease, "we may be able to reset the disease, turn it off," he said.
In some cases, x-rays show repair of the joint damage when biologics are given early enough, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Dr. Paul Emery, professor of rheumatology and head of the academic unit of musculoskeletal medicine at the University of Leeds (England), presented data at the 2011 EULAR Congress showing that after patients achieved remission with methotrexate and a biologic, they could be maintained on methotrexate. This approach has the advantage of maintaining remission with a less-costly drug that also poses fewer potentially adverse effects than a biologic agent. "We do not know the right combination initially, but it is being examined," said Dr. Cohen.
SDEF and this news organization are owned by Elsevier.
Dr. Cohen reported having no relevant conflicts of interest to disclose.
SAN FRANCISCO – Rheumatologists can prescribe drugs that can not only drive rheumatoid arthritis into remission but can also achieve some repair to the joints damaged by inflammation, according to Dr. Marc D. Cohen.
"In rheumatology, remission can never mean no disease. It just means not very much disease," said Dr. Cohen, emeritus professor of medicine at the Mayo Clinic, Rochester, Minn., and acting chief and professor of medicine at National Jewish Medical and Research Center in Denver.
"Rheumatologists need to be better sellers of what we can do. If you are not interested in changing the face of this disease, what are you doing?" he asked at the Perspectives in Rheumatic Diseases 2011 meeting.
In a review of the data on the efficacy of various biologic drugs in rheumatoid arthritis (RA), Dr. Cohen pointed out that, until the advent of biologics, there were no good trial data on the efficacy of methotrexate in RA. "The biologics are the best thing that ever happened to methotrexate, believe me," he said.
The study that put methotrexate on the map was the SWEFOT, in which investigators put all patients with RA on a trial of methotrexate before randomizing them to either triple therapy with methotrexate, sulfasalazine, and hydroxychloroquine or to methotrexate plus a tumor necrosis factor inhibitor (TNFi). The findings from the methotrexate-monotherapy portion of the trial showed that 30% of the patients improved on methotrexate alone (Lancet 2009;374:459-66).
Because of these findings, all patients get a trial of methotrexate first, as quickly as possible, ramping up the dose over 1-2 months, to see what happens. What may get overlooked is the investigators’ note that, while a subset of patients experience clinical benefit from methotrexate monotherapy, radiographic disease progression continues despite methotrexate making the patients feel better.
There is no way to predict which 30% may respond clinically to methotrexate. That is one reason why one may want to rush through ramping up the dose.
Commonly, the next step in treating RA is to apply triple therapy. Further findings from the SWEFOT trial of 487 patients with RA symptoms of less than 1 year’s duration showed that clinically at 2 years the two treatment groups were the same in terms of Disease Activity Score (DAS). However, patients given triple therapy had more radiographic progression than did those given a TNFi plus methotrexate.
"Is that important to your patient? I am not sure. The problem is that we have no way to measure that. We need a point system. If you have RA in your right big toe and you are a piano player that is probably not as bad as having wrist disease. Maybe we should weight them."
The bottom line is that the addition of a TNFi to the treatment regimen of someone who did not respond completely to methotrexate will improve the clinical and radiologic response in two to three times the number of patients (Lancet 2007;370:1861-74).
This combination approach does not capture everyone.
This is part of the motivation behind the push for primary care physicians to recognize RA early and get the patients to the rheumatologists for biologic therapy early. When the biologics are given aggressively within the first 6 months of the disease, "we may be able to reset the disease, turn it off," he said.
In some cases, x-rays show repair of the joint damage when biologics are given early enough, he said at the meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
Dr. Paul Emery, professor of rheumatology and head of the academic unit of musculoskeletal medicine at the University of Leeds (England), presented data at the 2011 EULAR Congress showing that after patients achieved remission with methotrexate and a biologic, they could be maintained on methotrexate. This approach has the advantage of maintaining remission with a less-costly drug that also poses fewer potentially adverse effects than a biologic agent. "We do not know the right combination initially, but it is being examined," said Dr. Cohen.
SDEF and this news organization are owned by Elsevier.
Dr. Cohen reported having no relevant conflicts of interest to disclose.
EXPERT ANALYSIS FROM THE PERSPECTIVES IN RHEUMATIC DISEASES 2011
RA Patients Have Made Treat-to-Target Personal
SAN FRANCISCO – Patients believe that setting specific goals at the beginning of a new therapy will help them achieve optimal treatment outcomes, in a slight variation of the treat-to-target mantra heard so widely in rheumatology these days.
Findings from an unpublished survey of 1,242 women and 587 men with moderate rheumatoid arthritis (RA) disease severity showed that at the start of treatment, 81% set personal or social goals (ability to garden or stand at a cocktail party), with 80% saying that the setting of such goals would be a good way to assess whether the new treatment was working; 91% set treatment goals (an MRI will show less inflammation in the joint), according to Dr. Vibeke Strand.
Most patients (87%) agreed that establishing such targets and achieving them would have a positive impact on their disease management.
Patients’ perceptions of goal setting included:
• I think setting personal and social goals would be of benefit as I can then assess whether my treatment is working or not in a simple to understand way (80% agreed).
• A treatment that works gets me to my personal and social goals quickly (84% agreed).
• If I set myself personal and social goals and achieve them, I would feel positive (87% agreed).
But they expected rapid results. About 81% wanted a new treatment to make them feel better within 3 months, and 56% said they would talk with their physician within less than a month of starting a new treatment if they felt no improvement, said Dr. Strand, adjunct clinical professor in the division of immunology at Stanford (Calif.) University.
A few were willing to give a new treatment longer to produce a benefit, with 20% saying they expected improved signs and symptoms within 3-6 months; only 5% were willing to wait more than 6 months.
Patients are just as impatient with their physicians as with their treatments. A total of 11% cited their physician as the biggest obstacle in controlling RA. Another 54% said that the leading challenge was finding the right treatment, and 16% named lack of education and understanding of RA. The remainder was made up of 11% who said lack of personal resolve was their biggest obstacle, and another 8% listed assorted other issues.
Over half of those surveyed (60%) had not heard of the treat-to-target approach to RA therapy. According to 61%, their physician did not manage their RA with strict goals and timeframes in place. But 62% said that they shared decisions with their physician on how best to treat their RA, Dr. Strand said at the Pespectives in Rheumatic Diseases 2011 meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
This survey was a follow-up to an earlier one of 1,958 women with RA from seven countries, including the United States, which was the first to characterize in detail the impact RA has on the daily lives of women and on their relationships. The survey was conducted on the Internet; all the women had been vetted as having RA of at least 6 months duration and all were 25-65 years of age.
The bottom line from that survey is that well into the era of biologics, women with rheumatoid arthritis report that pain remains a frequent and disabling symptom of their disease. Daily pain was reported by 63% of the women surveyed; 75% said they took pain medication daily, and 87% said they found it important to be able to describe the type and frequency of their RA-associated pain. Overall, 67% of the women reported that they constantly look for new ways to cope with their pain. When asked to describe a "good day with RA," 57% said it was a day free from pain, 58% said it was a day without fatigue, and 29% said it was a day when they were able to do everything easily.
Of the surveyed women, 68% reported that they felt it was necessary to conceal pain from their family and/or coworkers.
Regarding the effects of RA on their activities of daily living, 49% said it was difficult to keep fit, 45% found it difficult to garden, and 67% reported feeling less self-confident at work. Of the women who had been employed full time at diagnosis, 23% of the women had stopped working because of their disease and 27% reported they had cut back their work hours to part time.
The impact of RA extended beyond the workplace: 32% of the women said RA affected their closest relationships, with 55% reporting that they felt less confident in their sexuality; 31% reporting that they found it difficult to explain their sexual needs; of the 611 women who were single, 40% said RA played a role in it being difficult to find a partner.
The overarching weakness of both Internet surveys is the possibility that women with the worst disease were the ones who elected to complete the questionnaire, which may have introduced some bias, Dr. Strand noted.
The survey was funded by UCB, which manufactures Cimzia (certolizumab pegol). Dr. Strand disclosed that she has financial relationships with many companies that make treatments for rheumatoid arthritis, among other things.
SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – Patients believe that setting specific goals at the beginning of a new therapy will help them achieve optimal treatment outcomes, in a slight variation of the treat-to-target mantra heard so widely in rheumatology these days.
Findings from an unpublished survey of 1,242 women and 587 men with moderate rheumatoid arthritis (RA) disease severity showed that at the start of treatment, 81% set personal or social goals (ability to garden or stand at a cocktail party), with 80% saying that the setting of such goals would be a good way to assess whether the new treatment was working; 91% set treatment goals (an MRI will show less inflammation in the joint), according to Dr. Vibeke Strand.
Most patients (87%) agreed that establishing such targets and achieving them would have a positive impact on their disease management.
Patients’ perceptions of goal setting included:
• I think setting personal and social goals would be of benefit as I can then assess whether my treatment is working or not in a simple to understand way (80% agreed).
• A treatment that works gets me to my personal and social goals quickly (84% agreed).
• If I set myself personal and social goals and achieve them, I would feel positive (87% agreed).
But they expected rapid results. About 81% wanted a new treatment to make them feel better within 3 months, and 56% said they would talk with their physician within less than a month of starting a new treatment if they felt no improvement, said Dr. Strand, adjunct clinical professor in the division of immunology at Stanford (Calif.) University.
A few were willing to give a new treatment longer to produce a benefit, with 20% saying they expected improved signs and symptoms within 3-6 months; only 5% were willing to wait more than 6 months.
Patients are just as impatient with their physicians as with their treatments. A total of 11% cited their physician as the biggest obstacle in controlling RA. Another 54% said that the leading challenge was finding the right treatment, and 16% named lack of education and understanding of RA. The remainder was made up of 11% who said lack of personal resolve was their biggest obstacle, and another 8% listed assorted other issues.
Over half of those surveyed (60%) had not heard of the treat-to-target approach to RA therapy. According to 61%, their physician did not manage their RA with strict goals and timeframes in place. But 62% said that they shared decisions with their physician on how best to treat their RA, Dr. Strand said at the Pespectives in Rheumatic Diseases 2011 meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
This survey was a follow-up to an earlier one of 1,958 women with RA from seven countries, including the United States, which was the first to characterize in detail the impact RA has on the daily lives of women and on their relationships. The survey was conducted on the Internet; all the women had been vetted as having RA of at least 6 months duration and all were 25-65 years of age.
The bottom line from that survey is that well into the era of biologics, women with rheumatoid arthritis report that pain remains a frequent and disabling symptom of their disease. Daily pain was reported by 63% of the women surveyed; 75% said they took pain medication daily, and 87% said they found it important to be able to describe the type and frequency of their RA-associated pain. Overall, 67% of the women reported that they constantly look for new ways to cope with their pain. When asked to describe a "good day with RA," 57% said it was a day free from pain, 58% said it was a day without fatigue, and 29% said it was a day when they were able to do everything easily.
Of the surveyed women, 68% reported that they felt it was necessary to conceal pain from their family and/or coworkers.
Regarding the effects of RA on their activities of daily living, 49% said it was difficult to keep fit, 45% found it difficult to garden, and 67% reported feeling less self-confident at work. Of the women who had been employed full time at diagnosis, 23% of the women had stopped working because of their disease and 27% reported they had cut back their work hours to part time.
The impact of RA extended beyond the workplace: 32% of the women said RA affected their closest relationships, with 55% reporting that they felt less confident in their sexuality; 31% reporting that they found it difficult to explain their sexual needs; of the 611 women who were single, 40% said RA played a role in it being difficult to find a partner.
The overarching weakness of both Internet surveys is the possibility that women with the worst disease were the ones who elected to complete the questionnaire, which may have introduced some bias, Dr. Strand noted.
The survey was funded by UCB, which manufactures Cimzia (certolizumab pegol). Dr. Strand disclosed that she has financial relationships with many companies that make treatments for rheumatoid arthritis, among other things.
SDEF and this news organization are owned by Elsevier.
SAN FRANCISCO – Patients believe that setting specific goals at the beginning of a new therapy will help them achieve optimal treatment outcomes, in a slight variation of the treat-to-target mantra heard so widely in rheumatology these days.
Findings from an unpublished survey of 1,242 women and 587 men with moderate rheumatoid arthritis (RA) disease severity showed that at the start of treatment, 81% set personal or social goals (ability to garden or stand at a cocktail party), with 80% saying that the setting of such goals would be a good way to assess whether the new treatment was working; 91% set treatment goals (an MRI will show less inflammation in the joint), according to Dr. Vibeke Strand.
Most patients (87%) agreed that establishing such targets and achieving them would have a positive impact on their disease management.
Patients’ perceptions of goal setting included:
• I think setting personal and social goals would be of benefit as I can then assess whether my treatment is working or not in a simple to understand way (80% agreed).
• A treatment that works gets me to my personal and social goals quickly (84% agreed).
• If I set myself personal and social goals and achieve them, I would feel positive (87% agreed).
But they expected rapid results. About 81% wanted a new treatment to make them feel better within 3 months, and 56% said they would talk with their physician within less than a month of starting a new treatment if they felt no improvement, said Dr. Strand, adjunct clinical professor in the division of immunology at Stanford (Calif.) University.
A few were willing to give a new treatment longer to produce a benefit, with 20% saying they expected improved signs and symptoms within 3-6 months; only 5% were willing to wait more than 6 months.
Patients are just as impatient with their physicians as with their treatments. A total of 11% cited their physician as the biggest obstacle in controlling RA. Another 54% said that the leading challenge was finding the right treatment, and 16% named lack of education and understanding of RA. The remainder was made up of 11% who said lack of personal resolve was their biggest obstacle, and another 8% listed assorted other issues.
Over half of those surveyed (60%) had not heard of the treat-to-target approach to RA therapy. According to 61%, their physician did not manage their RA with strict goals and timeframes in place. But 62% said that they shared decisions with their physician on how best to treat their RA, Dr. Strand said at the Pespectives in Rheumatic Diseases 2011 meeting, which was sponsored in part by the Skin Disease Education Foundation (SDEF).
This survey was a follow-up to an earlier one of 1,958 women with RA from seven countries, including the United States, which was the first to characterize in detail the impact RA has on the daily lives of women and on their relationships. The survey was conducted on the Internet; all the women had been vetted as having RA of at least 6 months duration and all were 25-65 years of age.
The bottom line from that survey is that well into the era of biologics, women with rheumatoid arthritis report that pain remains a frequent and disabling symptom of their disease. Daily pain was reported by 63% of the women surveyed; 75% said they took pain medication daily, and 87% said they found it important to be able to describe the type and frequency of their RA-associated pain. Overall, 67% of the women reported that they constantly look for new ways to cope with their pain. When asked to describe a "good day with RA," 57% said it was a day free from pain, 58% said it was a day without fatigue, and 29% said it was a day when they were able to do everything easily.
Of the surveyed women, 68% reported that they felt it was necessary to conceal pain from their family and/or coworkers.
Regarding the effects of RA on their activities of daily living, 49% said it was difficult to keep fit, 45% found it difficult to garden, and 67% reported feeling less self-confident at work. Of the women who had been employed full time at diagnosis, 23% of the women had stopped working because of their disease and 27% reported they had cut back their work hours to part time.
The impact of RA extended beyond the workplace: 32% of the women said RA affected their closest relationships, with 55% reporting that they felt less confident in their sexuality; 31% reporting that they found it difficult to explain their sexual needs; of the 611 women who were single, 40% said RA played a role in it being difficult to find a partner.
The overarching weakness of both Internet surveys is the possibility that women with the worst disease were the ones who elected to complete the questionnaire, which may have introduced some bias, Dr. Strand noted.
The survey was funded by UCB, which manufactures Cimzia (certolizumab pegol). Dr. Strand disclosed that she has financial relationships with many companies that make treatments for rheumatoid arthritis, among other things.
SDEF and this news organization are owned by Elsevier.
EXPERT ANALYSIS FROM THE PERSPECTIVES IN RHEUMATIC DISEASES 2011
Measures of RA Progression Remain Flawed Predictors of Outcomes
CHICAGO – The disease activity score outcome in rheumatoid arthritis should be used with caution as a treatment target when the clinical aim is to prevent radiographic progression. The DAS may show that a patient is in remission when in fact the disease is still active.
The van der Heijde/Sharp score is also flawed in that the total mean change is less meaningful than is the probability of progression of rheumatoid arthritis (RA) and may be misleading, said Dr. Edward Keystone.
"The change in the mean Sharp score point is of some importance, but not nearly as important as the proportion of people who are progressing, or those particularly rapid progressors," said Dr. Keystone, professor of medicine at the University of Toronto. In general, a large change in Sharp score points is needed to reduce physical function, noting that a change in 2 points per year will be significant over a decade, he said.
"If you change by 3 [points] a year, in 10 years you’re going to have disability."
Joint space narrowing may be more predictive than are erosions of radiographic progression. "Most methotrexate-inadequate responders, despite the fact that they’re clinically active, may still have less radiographic progression," Dr. Keystone said at the Midwest Rheumatology Summit.
"So how good is methotrexate, in patients failing methotrexate?" he said. "That’s the question."
Remission is the clinical target in RA, but its measurement is complex. True remission is a state of low-disease activity in patients who are not progressing, said Dr. Keystone. Unfortunately, there is dissociation between clinical and radiographic outcomes, and radiographic progression may occur in patients in clinical remission. Patients with active disease may likewise not progress radiographically.
The composite indices defining remission allow for a significant degree of clinical synovitis, and residual synovitis detected with sensitive imaging might explain the progression in structural damage, even in clinical remission (Arthritis Rheum. 2006;4:3761-73).
Joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ.
As for patients with clinical disease activity who do not progress radiographically, Dr. Keystone said that the concept comes from the ACR 20 nonresponders.
"People who do not make an ACR 20 are still responders," said Dr. Keystone. It’s the difference in patient-derived vs. physician-derived outcomes, he said. In established disease, ACR 20 nonresponders to biologics do not seem to progress radiographically but may still improve.
"Why do most people not achieve an ACR 20? It’s not the swollen and tender joint. It’s usually the patient-derived outcome. ... That’s the problem: The patient says ‘I’m not better.’ Therefore when you look at the ACR 20 data, he’s a nonresponder."
Early disease can present conundrums as well.
In the PREMIER study, methotrexate was clinically identical to monotherapy adalimumab. Nevertheless, a 10-point Sharp score change was observed with methotrexate alone, vs. a 5-point Sharp score change with adalimumab monotherapy (Arthritis Rheum. 2006;54:26-37).
"Clinically, they looked alike, but radiographically, adalimumab monotherapy was much better in reducing the Sharp score." However, he said, the mean change in total Sharp score reflects the Total Sharp Score change only of those patients progressing. "And rheumatologists make decisions on the basis of probability, not mean change in [total Sharp score]," he said. The mean change in total Sharp score means less than the probability of progression, and may lead you astray, he said.
The 52-week results from the JESMR (Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan) study found that combination therapy of etanercept plus methotrexate resulted in better clinical and radiographic outcomes than etanercept monotherapy, even in patients with active rheumatoid arthritis and despite methotrexate treatment. (Rheumatology 2011;38:1585-92). This led to the conclusion that methotrexate should be continued at the commencement of etanercept therapy even in patients with rheumatoid arthritis who showed an inappropriate response to methotrexate as demonstrated by changes in radiographic progression.
However, only four patients were rapid progressors, said Dr. Keystone, leading him to conclude that it may not be so bad to stop methotrexate, because the probability of being a rapid progressor is not very high.
In early rheumatoid arthritis, radiographic progression influences disability in a short time, according to results of TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) (Ann. Rheum. Dis. 2008;67:1267-70).
The PREMIER study found a relationship between structural damage, as reflected in the total Sharp score and disability, as measured by the Health Assessment Questionnaire (HAQ) (J. Rheumatol. 2010;37:2237-46). The trial quantified the meaning of progression of joint damage to physical function in early rheumatoid arthritis as a noticeable change in physical function would occur with an approximate 100-unit change in total Sharp score.
Radiographic progression results in disability early in disease, said Dr. Keystone, but a substantial change in total Sharp score is needed to have a noticeable change in physical function in both early and established disease.
Furthermore, joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ (Rheumatology 2004;43:79-84).
"Joint space narrowing determines unemployment," said Dr. Keystone. It has a greater effect than do erosions on disability.
Finally, he said that timing of response is predictive of long-term outcome. The disease state achieved at 12 weeks is a predictor of long-term outcome. The U.S. is the last country in the world to adopt Treat to Target, as described in the EULAR treatment recommendations (Ann. Rheum. Dis. 2010;69:964-75).
It is not just the target achieved, it\'s the time to reach the target that’s important, said Dr. Keystone.
"People who have a lot of pain, a lot of disability at baseline, they often take longer than people who are in the lower disease state. And it’s patient-derived outcomes that made the difference," said Dr. Keystone. "The sicker you are, the worse you are in terms of what the difference or the cost of delay is."
The Foundation for Osteoporosis Research and Education, a CME accredited provider, acknowledged commercial support for this meeting from Abbott, Amgen, Centocor, Genentech, Human Genome Science, and UCB. Dr. Keystone disclosed financial relationships with Abbott, Amgen, AstraZeneca, Biotest, BMS, Centocor, Genentech, Genzyme, Merck, Novartis, Nycomed, Pfizer, Roche, and UCB.
CHICAGO – The disease activity score outcome in rheumatoid arthritis should be used with caution as a treatment target when the clinical aim is to prevent radiographic progression. The DAS may show that a patient is in remission when in fact the disease is still active.
The van der Heijde/Sharp score is also flawed in that the total mean change is less meaningful than is the probability of progression of rheumatoid arthritis (RA) and may be misleading, said Dr. Edward Keystone.
"The change in the mean Sharp score point is of some importance, but not nearly as important as the proportion of people who are progressing, or those particularly rapid progressors," said Dr. Keystone, professor of medicine at the University of Toronto. In general, a large change in Sharp score points is needed to reduce physical function, noting that a change in 2 points per year will be significant over a decade, he said.
"If you change by 3 [points] a year, in 10 years you’re going to have disability."
Joint space narrowing may be more predictive than are erosions of radiographic progression. "Most methotrexate-inadequate responders, despite the fact that they’re clinically active, may still have less radiographic progression," Dr. Keystone said at the Midwest Rheumatology Summit.
"So how good is methotrexate, in patients failing methotrexate?" he said. "That’s the question."
Remission is the clinical target in RA, but its measurement is complex. True remission is a state of low-disease activity in patients who are not progressing, said Dr. Keystone. Unfortunately, there is dissociation between clinical and radiographic outcomes, and radiographic progression may occur in patients in clinical remission. Patients with active disease may likewise not progress radiographically.
The composite indices defining remission allow for a significant degree of clinical synovitis, and residual synovitis detected with sensitive imaging might explain the progression in structural damage, even in clinical remission (Arthritis Rheum. 2006;4:3761-73).
Joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ.
As for patients with clinical disease activity who do not progress radiographically, Dr. Keystone said that the concept comes from the ACR 20 nonresponders.
"People who do not make an ACR 20 are still responders," said Dr. Keystone. It’s the difference in patient-derived vs. physician-derived outcomes, he said. In established disease, ACR 20 nonresponders to biologics do not seem to progress radiographically but may still improve.
"Why do most people not achieve an ACR 20? It’s not the swollen and tender joint. It’s usually the patient-derived outcome. ... That’s the problem: The patient says ‘I’m not better.’ Therefore when you look at the ACR 20 data, he’s a nonresponder."
Early disease can present conundrums as well.
In the PREMIER study, methotrexate was clinically identical to monotherapy adalimumab. Nevertheless, a 10-point Sharp score change was observed with methotrexate alone, vs. a 5-point Sharp score change with adalimumab monotherapy (Arthritis Rheum. 2006;54:26-37).
"Clinically, they looked alike, but radiographically, adalimumab monotherapy was much better in reducing the Sharp score." However, he said, the mean change in total Sharp score reflects the Total Sharp Score change only of those patients progressing. "And rheumatologists make decisions on the basis of probability, not mean change in [total Sharp score]," he said. The mean change in total Sharp score means less than the probability of progression, and may lead you astray, he said.
The 52-week results from the JESMR (Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan) study found that combination therapy of etanercept plus methotrexate resulted in better clinical and radiographic outcomes than etanercept monotherapy, even in patients with active rheumatoid arthritis and despite methotrexate treatment. (Rheumatology 2011;38:1585-92). This led to the conclusion that methotrexate should be continued at the commencement of etanercept therapy even in patients with rheumatoid arthritis who showed an inappropriate response to methotrexate as demonstrated by changes in radiographic progression.
However, only four patients were rapid progressors, said Dr. Keystone, leading him to conclude that it may not be so bad to stop methotrexate, because the probability of being a rapid progressor is not very high.
In early rheumatoid arthritis, radiographic progression influences disability in a short time, according to results of TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) (Ann. Rheum. Dis. 2008;67:1267-70).
The PREMIER study found a relationship between structural damage, as reflected in the total Sharp score and disability, as measured by the Health Assessment Questionnaire (HAQ) (J. Rheumatol. 2010;37:2237-46). The trial quantified the meaning of progression of joint damage to physical function in early rheumatoid arthritis as a noticeable change in physical function would occur with an approximate 100-unit change in total Sharp score.
Radiographic progression results in disability early in disease, said Dr. Keystone, but a substantial change in total Sharp score is needed to have a noticeable change in physical function in both early and established disease.
Furthermore, joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ (Rheumatology 2004;43:79-84).
"Joint space narrowing determines unemployment," said Dr. Keystone. It has a greater effect than do erosions on disability.
Finally, he said that timing of response is predictive of long-term outcome. The disease state achieved at 12 weeks is a predictor of long-term outcome. The U.S. is the last country in the world to adopt Treat to Target, as described in the EULAR treatment recommendations (Ann. Rheum. Dis. 2010;69:964-75).
It is not just the target achieved, it\'s the time to reach the target that’s important, said Dr. Keystone.
"People who have a lot of pain, a lot of disability at baseline, they often take longer than people who are in the lower disease state. And it’s patient-derived outcomes that made the difference," said Dr. Keystone. "The sicker you are, the worse you are in terms of what the difference or the cost of delay is."
The Foundation for Osteoporosis Research and Education, a CME accredited provider, acknowledged commercial support for this meeting from Abbott, Amgen, Centocor, Genentech, Human Genome Science, and UCB. Dr. Keystone disclosed financial relationships with Abbott, Amgen, AstraZeneca, Biotest, BMS, Centocor, Genentech, Genzyme, Merck, Novartis, Nycomed, Pfizer, Roche, and UCB.
CHICAGO – The disease activity score outcome in rheumatoid arthritis should be used with caution as a treatment target when the clinical aim is to prevent radiographic progression. The DAS may show that a patient is in remission when in fact the disease is still active.
The van der Heijde/Sharp score is also flawed in that the total mean change is less meaningful than is the probability of progression of rheumatoid arthritis (RA) and may be misleading, said Dr. Edward Keystone.
"The change in the mean Sharp score point is of some importance, but not nearly as important as the proportion of people who are progressing, or those particularly rapid progressors," said Dr. Keystone, professor of medicine at the University of Toronto. In general, a large change in Sharp score points is needed to reduce physical function, noting that a change in 2 points per year will be significant over a decade, he said.
"If you change by 3 [points] a year, in 10 years you’re going to have disability."
Joint space narrowing may be more predictive than are erosions of radiographic progression. "Most methotrexate-inadequate responders, despite the fact that they’re clinically active, may still have less radiographic progression," Dr. Keystone said at the Midwest Rheumatology Summit.
"So how good is methotrexate, in patients failing methotrexate?" he said. "That’s the question."
Remission is the clinical target in RA, but its measurement is complex. True remission is a state of low-disease activity in patients who are not progressing, said Dr. Keystone. Unfortunately, there is dissociation between clinical and radiographic outcomes, and radiographic progression may occur in patients in clinical remission. Patients with active disease may likewise not progress radiographically.
The composite indices defining remission allow for a significant degree of clinical synovitis, and residual synovitis detected with sensitive imaging might explain the progression in structural damage, even in clinical remission (Arthritis Rheum. 2006;4:3761-73).
Joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ.
As for patients with clinical disease activity who do not progress radiographically, Dr. Keystone said that the concept comes from the ACR 20 nonresponders.
"People who do not make an ACR 20 are still responders," said Dr. Keystone. It’s the difference in patient-derived vs. physician-derived outcomes, he said. In established disease, ACR 20 nonresponders to biologics do not seem to progress radiographically but may still improve.
"Why do most people not achieve an ACR 20? It’s not the swollen and tender joint. It’s usually the patient-derived outcome. ... That’s the problem: The patient says ‘I’m not better.’ Therefore when you look at the ACR 20 data, he’s a nonresponder."
Early disease can present conundrums as well.
In the PREMIER study, methotrexate was clinically identical to monotherapy adalimumab. Nevertheless, a 10-point Sharp score change was observed with methotrexate alone, vs. a 5-point Sharp score change with adalimumab monotherapy (Arthritis Rheum. 2006;54:26-37).
"Clinically, they looked alike, but radiographically, adalimumab monotherapy was much better in reducing the Sharp score." However, he said, the mean change in total Sharp score reflects the Total Sharp Score change only of those patients progressing. "And rheumatologists make decisions on the basis of probability, not mean change in [total Sharp score]," he said. The mean change in total Sharp score means less than the probability of progression, and may lead you astray, he said.
The 52-week results from the JESMR (Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan) study found that combination therapy of etanercept plus methotrexate resulted in better clinical and radiographic outcomes than etanercept monotherapy, even in patients with active rheumatoid arthritis and despite methotrexate treatment. (Rheumatology 2011;38:1585-92). This led to the conclusion that methotrexate should be continued at the commencement of etanercept therapy even in patients with rheumatoid arthritis who showed an inappropriate response to methotrexate as demonstrated by changes in radiographic progression.
However, only four patients were rapid progressors, said Dr. Keystone, leading him to conclude that it may not be so bad to stop methotrexate, because the probability of being a rapid progressor is not very high.
In early rheumatoid arthritis, radiographic progression influences disability in a short time, according to results of TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) (Ann. Rheum. Dis. 2008;67:1267-70).
The PREMIER study found a relationship between structural damage, as reflected in the total Sharp score and disability, as measured by the Health Assessment Questionnaire (HAQ) (J. Rheumatol. 2010;37:2237-46). The trial quantified the meaning of progression of joint damage to physical function in early rheumatoid arthritis as a noticeable change in physical function would occur with an approximate 100-unit change in total Sharp score.
Radiographic progression results in disability early in disease, said Dr. Keystone, but a substantial change in total Sharp score is needed to have a noticeable change in physical function in both early and established disease.
Furthermore, joint space narrowing is more predictive of disability than erosion, as demonstrated by the 5-year HAQ (Rheumatology 2004;43:79-84).
"Joint space narrowing determines unemployment," said Dr. Keystone. It has a greater effect than do erosions on disability.
Finally, he said that timing of response is predictive of long-term outcome. The disease state achieved at 12 weeks is a predictor of long-term outcome. The U.S. is the last country in the world to adopt Treat to Target, as described in the EULAR treatment recommendations (Ann. Rheum. Dis. 2010;69:964-75).
It is not just the target achieved, it\'s the time to reach the target that’s important, said Dr. Keystone.
"People who have a lot of pain, a lot of disability at baseline, they often take longer than people who are in the lower disease state. And it’s patient-derived outcomes that made the difference," said Dr. Keystone. "The sicker you are, the worse you are in terms of what the difference or the cost of delay is."
The Foundation for Osteoporosis Research and Education, a CME accredited provider, acknowledged commercial support for this meeting from Abbott, Amgen, Centocor, Genentech, Human Genome Science, and UCB. Dr. Keystone disclosed financial relationships with Abbott, Amgen, AstraZeneca, Biotest, BMS, Centocor, Genentech, Genzyme, Merck, Novartis, Nycomed, Pfizer, Roche, and UCB.
EXPERT ANALYSIS FROM THE MIDWEST RHEUMATOLOGY SUMMIT
Joint Distraction May Delay Knee Replacement
SAN DIEGO – Separating an osteoarthritic knee joint for 2 months – that is, stretching the top of the tibia away from the base of the femur and holding the bones in place with pins set into an external fixation frame – stimulates the joint to produce new cartilage, thereby reducing pain and improving function for at least 2 years, according to findings from a small European pilot study.
The 20 patients in the trial were all facing knee replacement due to osteoarthritis (OA); the technique, known as knee joint distraction, has postponed surgery for 2 years and counting in the subjects. The hope is the patients will never need an artificial knee, according to senior investigator Dr. Floris Lafeber, a professor of experimental rheumatology at the University Medical Center Utrecht (the Netherlands).
Their minimum joint space width increased from a baseline mean of 1.0 mm to 1.8 mm at 2 years. Patients started the trial with, on average, about 22% of their subchondral bone denuded; that dropped to about 8% at 2 years.
In short, there was an “astonishing increase in cartilage volume,” Dr. Lafeber said at the congress, which was sponsored by the Osteoarthritis Research Society International.
Meanwhile, total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores increased from about 45% at baseline to about 78% at 2 years, with improvements in WOMAC pain, function, and stiffness subscales. Visual Analog Scale pain scores improved from 73 at baseline to 28 at 2 years. The results were statistically significant.
The technique, which had been used in the past for ankle OAs, “looks very promising” for osteoarthritic knees, Dr. Lafeber said. The 1 year results have been previously published (Ann. Rheum. Dis. 2011;70:1441-6;; Rheumatology News, August 2011, p. 28)
His team will next pit knee distraction against total knee replacement and osteotomy in two randomized trials. The researchers will keep tracking the original 20 patients as well. “We are now having follow-up of the first patients for more than 4 years, and no prostheses are placed yet,” Dr. Lafeber said.
The researchers plan “more sophisticated MRIs to look at the quality of the cartilage,” although the increased joint space on weight-bearing x-rays suggests mechanical competence. Biomarker analysis also suggests “the quality of the cartilage has a hyaline aspect,” according to Dr. Lafeber.
The 20 patients' average age was 49 years; 11 were women. All had end-stage, unilateral knee OA with severe pain and cartilage damage. Patients with major problems in both knees were excluded from the study. In a variation of the Ilizarov procedure, a tube with internal coil springs was placed on each side of the patients' osteoarthritic knees, bridging the joints. Joints were then distracted to 5 mm over a few days. Full weight bearing was allowed. The tubes and pins were removed after 2 months.
The theory is that temporarily unloading the knee prevents additional wear and tear and allows cartilage to start repairing itself. Pin sites became infected in 17 of the 20 patients, and were treated with local and oral antibiotics. Dr. Lafeber said he and his colleagues hope that technique refinements will reduce the infection rate.
“On the MRI, it looked [as if] the cartilage was regenerated, but it's unlikely to be truly hyaline articular cartilage.
“It's much more likely to be fibrocartilage, repair-type cartilage. It's difficult to know how long [patients] maintain that fibrocartilage” before it's worn away, said Dr. David Hunter, a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. “In terms of the clinical applicability of that intervention, I'm not sure it has much utility,”he said, noting that, pending randomized trial results, doubt about the clinical utility of the technique must be maintained.
Dr. Lafeber and Dr. Hunter each reported having no disclosures. The work was supported by the Dutch Arthritis Association.
Three years after a 2-month joint distraction, joint space is larger.
Source Images courtesy Dr. Floris Lafeber
SAN DIEGO – Separating an osteoarthritic knee joint for 2 months – that is, stretching the top of the tibia away from the base of the femur and holding the bones in place with pins set into an external fixation frame – stimulates the joint to produce new cartilage, thereby reducing pain and improving function for at least 2 years, according to findings from a small European pilot study.
The 20 patients in the trial were all facing knee replacement due to osteoarthritis (OA); the technique, known as knee joint distraction, has postponed surgery for 2 years and counting in the subjects. The hope is the patients will never need an artificial knee, according to senior investigator Dr. Floris Lafeber, a professor of experimental rheumatology at the University Medical Center Utrecht (the Netherlands).
Their minimum joint space width increased from a baseline mean of 1.0 mm to 1.8 mm at 2 years. Patients started the trial with, on average, about 22% of their subchondral bone denuded; that dropped to about 8% at 2 years.
In short, there was an “astonishing increase in cartilage volume,” Dr. Lafeber said at the congress, which was sponsored by the Osteoarthritis Research Society International.
Meanwhile, total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores increased from about 45% at baseline to about 78% at 2 years, with improvements in WOMAC pain, function, and stiffness subscales. Visual Analog Scale pain scores improved from 73 at baseline to 28 at 2 years. The results were statistically significant.
The technique, which had been used in the past for ankle OAs, “looks very promising” for osteoarthritic knees, Dr. Lafeber said. The 1 year results have been previously published (Ann. Rheum. Dis. 2011;70:1441-6;; Rheumatology News, August 2011, p. 28)
His team will next pit knee distraction against total knee replacement and osteotomy in two randomized trials. The researchers will keep tracking the original 20 patients as well. “We are now having follow-up of the first patients for more than 4 years, and no prostheses are placed yet,” Dr. Lafeber said.
The researchers plan “more sophisticated MRIs to look at the quality of the cartilage,” although the increased joint space on weight-bearing x-rays suggests mechanical competence. Biomarker analysis also suggests “the quality of the cartilage has a hyaline aspect,” according to Dr. Lafeber.
The 20 patients' average age was 49 years; 11 were women. All had end-stage, unilateral knee OA with severe pain and cartilage damage. Patients with major problems in both knees were excluded from the study. In a variation of the Ilizarov procedure, a tube with internal coil springs was placed on each side of the patients' osteoarthritic knees, bridging the joints. Joints were then distracted to 5 mm over a few days. Full weight bearing was allowed. The tubes and pins were removed after 2 months.
The theory is that temporarily unloading the knee prevents additional wear and tear and allows cartilage to start repairing itself. Pin sites became infected in 17 of the 20 patients, and were treated with local and oral antibiotics. Dr. Lafeber said he and his colleagues hope that technique refinements will reduce the infection rate.
“On the MRI, it looked [as if] the cartilage was regenerated, but it's unlikely to be truly hyaline articular cartilage.
“It's much more likely to be fibrocartilage, repair-type cartilage. It's difficult to know how long [patients] maintain that fibrocartilage” before it's worn away, said Dr. David Hunter, a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. “In terms of the clinical applicability of that intervention, I'm not sure it has much utility,”he said, noting that, pending randomized trial results, doubt about the clinical utility of the technique must be maintained.
Dr. Lafeber and Dr. Hunter each reported having no disclosures. The work was supported by the Dutch Arthritis Association.
Three years after a 2-month joint distraction, joint space is larger.
Source Images courtesy Dr. Floris Lafeber
SAN DIEGO – Separating an osteoarthritic knee joint for 2 months – that is, stretching the top of the tibia away from the base of the femur and holding the bones in place with pins set into an external fixation frame – stimulates the joint to produce new cartilage, thereby reducing pain and improving function for at least 2 years, according to findings from a small European pilot study.
The 20 patients in the trial were all facing knee replacement due to osteoarthritis (OA); the technique, known as knee joint distraction, has postponed surgery for 2 years and counting in the subjects. The hope is the patients will never need an artificial knee, according to senior investigator Dr. Floris Lafeber, a professor of experimental rheumatology at the University Medical Center Utrecht (the Netherlands).
Their minimum joint space width increased from a baseline mean of 1.0 mm to 1.8 mm at 2 years. Patients started the trial with, on average, about 22% of their subchondral bone denuded; that dropped to about 8% at 2 years.
In short, there was an “astonishing increase in cartilage volume,” Dr. Lafeber said at the congress, which was sponsored by the Osteoarthritis Research Society International.
Meanwhile, total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores increased from about 45% at baseline to about 78% at 2 years, with improvements in WOMAC pain, function, and stiffness subscales. Visual Analog Scale pain scores improved from 73 at baseline to 28 at 2 years. The results were statistically significant.
The technique, which had been used in the past for ankle OAs, “looks very promising” for osteoarthritic knees, Dr. Lafeber said. The 1 year results have been previously published (Ann. Rheum. Dis. 2011;70:1441-6;; Rheumatology News, August 2011, p. 28)
His team will next pit knee distraction against total knee replacement and osteotomy in two randomized trials. The researchers will keep tracking the original 20 patients as well. “We are now having follow-up of the first patients for more than 4 years, and no prostheses are placed yet,” Dr. Lafeber said.
The researchers plan “more sophisticated MRIs to look at the quality of the cartilage,” although the increased joint space on weight-bearing x-rays suggests mechanical competence. Biomarker analysis also suggests “the quality of the cartilage has a hyaline aspect,” according to Dr. Lafeber.
The 20 patients' average age was 49 years; 11 were women. All had end-stage, unilateral knee OA with severe pain and cartilage damage. Patients with major problems in both knees were excluded from the study. In a variation of the Ilizarov procedure, a tube with internal coil springs was placed on each side of the patients' osteoarthritic knees, bridging the joints. Joints were then distracted to 5 mm over a few days. Full weight bearing was allowed. The tubes and pins were removed after 2 months.
The theory is that temporarily unloading the knee prevents additional wear and tear and allows cartilage to start repairing itself. Pin sites became infected in 17 of the 20 patients, and were treated with local and oral antibiotics. Dr. Lafeber said he and his colleagues hope that technique refinements will reduce the infection rate.
“On the MRI, it looked [as if] the cartilage was regenerated, but it's unlikely to be truly hyaline articular cartilage.
“It's much more likely to be fibrocartilage, repair-type cartilage. It's difficult to know how long [patients] maintain that fibrocartilage” before it's worn away, said Dr. David Hunter, a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. “In terms of the clinical applicability of that intervention, I'm not sure it has much utility,”he said, noting that, pending randomized trial results, doubt about the clinical utility of the technique must be maintained.
Dr. Lafeber and Dr. Hunter each reported having no disclosures. The work was supported by the Dutch Arthritis Association.
Three years after a 2-month joint distraction, joint space is larger.
Source Images courtesy Dr. Floris Lafeber
Hand OA Questionnaires Are Not Comprehensive
Major Finding: When asked, 211 Norwegians with hand osteoarthritis listed 311 tasks their OA made difficult.
Data Source: Survey conducted using the Australian/Canadian Hand Osteoarthritis Index.
Disclosures: The study was paid for by the Norwegian Occupational Therapy Association and the Oslo Rheumatism Association. Dr. Fernandes said she has no disclosures.
SAN DIEGO – Hand osteoarthritis causes a wide range of problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.
In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more cited buttoning and unbuttoning clothes, as well as carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.
Those items are among the nine tasks listed on the widely used Australian/Canadian (AUSCAN) Hand Osteoarthritis Index questionnaire, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
But more than half of the Norwegian sample had a hard time opening bottles, too.
About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the congress, sponsored by the Osteoarthritis Research Society International.
Patients did not mention problems with opening doors and turning on faucets, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. These items are on the AUSCAN, Dr. Fernandes said.
“The outcome measures we have today,” which also include Dreiser's Functional Index, “are all expert opinion–based questionnaires. They haven't really asked the patients themselves” about their struggles, she said.
She and her colleagues said they hope to develop a more comprehensive questionnaire.
Meanwhile, they said, physicians should go beyond current questionnaires to learn more about the challenges their patients face. Lid handles to open jars, as well as grip-strength and range of motion exercises, especially for the thumb, may also help patients, Dr. Fernandes said.
The study involved 201 women and 10 men, average age 63 years, recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim.
They had a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.
Major Finding: When asked, 211 Norwegians with hand osteoarthritis listed 311 tasks their OA made difficult.
Data Source: Survey conducted using the Australian/Canadian Hand Osteoarthritis Index.
Disclosures: The study was paid for by the Norwegian Occupational Therapy Association and the Oslo Rheumatism Association. Dr. Fernandes said she has no disclosures.
SAN DIEGO – Hand osteoarthritis causes a wide range of problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.
In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more cited buttoning and unbuttoning clothes, as well as carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.
Those items are among the nine tasks listed on the widely used Australian/Canadian (AUSCAN) Hand Osteoarthritis Index questionnaire, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
But more than half of the Norwegian sample had a hard time opening bottles, too.
About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the congress, sponsored by the Osteoarthritis Research Society International.
Patients did not mention problems with opening doors and turning on faucets, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. These items are on the AUSCAN, Dr. Fernandes said.
“The outcome measures we have today,” which also include Dreiser's Functional Index, “are all expert opinion–based questionnaires. They haven't really asked the patients themselves” about their struggles, she said.
She and her colleagues said they hope to develop a more comprehensive questionnaire.
Meanwhile, they said, physicians should go beyond current questionnaires to learn more about the challenges their patients face. Lid handles to open jars, as well as grip-strength and range of motion exercises, especially for the thumb, may also help patients, Dr. Fernandes said.
The study involved 201 women and 10 men, average age 63 years, recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim.
They had a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.
Major Finding: When asked, 211 Norwegians with hand osteoarthritis listed 311 tasks their OA made difficult.
Data Source: Survey conducted using the Australian/Canadian Hand Osteoarthritis Index.
Disclosures: The study was paid for by the Norwegian Occupational Therapy Association and the Oslo Rheumatism Association. Dr. Fernandes said she has no disclosures.
SAN DIEGO – Hand osteoarthritis causes a wide range of problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.
In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more cited buttoning and unbuttoning clothes, as well as carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.
Those items are among the nine tasks listed on the widely used Australian/Canadian (AUSCAN) Hand Osteoarthritis Index questionnaire, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
But more than half of the Norwegian sample had a hard time opening bottles, too.
About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the congress, sponsored by the Osteoarthritis Research Society International.
Patients did not mention problems with opening doors and turning on faucets, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. These items are on the AUSCAN, Dr. Fernandes said.
“The outcome measures we have today,” which also include Dreiser's Functional Index, “are all expert opinion–based questionnaires. They haven't really asked the patients themselves” about their struggles, she said.
She and her colleagues said they hope to develop a more comprehensive questionnaire.
Meanwhile, they said, physicians should go beyond current questionnaires to learn more about the challenges their patients face. Lid handles to open jars, as well as grip-strength and range of motion exercises, especially for the thumb, may also help patients, Dr. Fernandes said.
The study involved 201 women and 10 men, average age 63 years, recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim.
They had a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.
Osteotomy Surgery on One Knee Stresses the Opposite Joint
Major Finding: At 2 years after a unilateral, opening-wedge high tibial osteotomy, 38 patients experienced a mean 0.25% body weight times height increase in peak knee adduction moment in the nonoperative limb.
Data Source: Comparison of baseline values to 2-year postop values.
Disclosures: The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris said he had no disclosures.
SAN DIEGO – Unilateral, medial, opening-wedge high tibial osteotomy on one knee increases joint load on the other.
The procedure is used to correct varus malalignment, according to researchers at the University of Western Ontario, London. The findings apply to a subset of opening-wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.
In 38 such patients, 2 years after surgery “we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb,” as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.
“The major point is to pay attention to what's happening to the opposite knee,” he said. An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease. During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee.
Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m
Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.
Knee adduction moment had also significantly decreased on the operative side (mean change, −1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, −1.43 degrees). The findings were statistically significant.
Major Finding: At 2 years after a unilateral, opening-wedge high tibial osteotomy, 38 patients experienced a mean 0.25% body weight times height increase in peak knee adduction moment in the nonoperative limb.
Data Source: Comparison of baseline values to 2-year postop values.
Disclosures: The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris said he had no disclosures.
SAN DIEGO – Unilateral, medial, opening-wedge high tibial osteotomy on one knee increases joint load on the other.
The procedure is used to correct varus malalignment, according to researchers at the University of Western Ontario, London. The findings apply to a subset of opening-wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.
In 38 such patients, 2 years after surgery “we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb,” as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.
“The major point is to pay attention to what's happening to the opposite knee,” he said. An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease. During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee.
Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m
Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.
Knee adduction moment had also significantly decreased on the operative side (mean change, −1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, −1.43 degrees). The findings were statistically significant.
Major Finding: At 2 years after a unilateral, opening-wedge high tibial osteotomy, 38 patients experienced a mean 0.25% body weight times height increase in peak knee adduction moment in the nonoperative limb.
Data Source: Comparison of baseline values to 2-year postop values.
Disclosures: The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris said he had no disclosures.
SAN DIEGO – Unilateral, medial, opening-wedge high tibial osteotomy on one knee increases joint load on the other.
The procedure is used to correct varus malalignment, according to researchers at the University of Western Ontario, London. The findings apply to a subset of opening-wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.
In 38 such patients, 2 years after surgery “we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb,” as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.
“The major point is to pay attention to what's happening to the opposite knee,” he said. An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease. During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee.
Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m
Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.
Knee adduction moment had also significantly decreased on the operative side (mean change, −1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, −1.43 degrees). The findings were statistically significant.
'No Pain, No Gain' True in Strength Training
Major Finding: After 8 weeks of strength training, subjects whose knees had been injected with a painful saline solution before each workout had quadriceps that were 22% stronger; the quadriceps of peers who didn't get painful injections were 7% stronger.
Data Source: Randomized, controlled trial involving 27 people.
Disclosures: Ms. Sorensen said she has no disclosures. The work was supported by the Association of Danish Physiotherapists.
SAN DIEGO – Induced knee pain appears to have improved strength training in a small, Danish randomized trial.
Researchers injected the right knee infrapatellar fat pads of 13 healthy subjects in their mid-20s with painful, hypertonic saline. Immediately afterward, participants did three sets of leg presses and knee extensions. After three sessions per week for 8 weeks, their right quadriceps were 22% stronger than at baseline. Fourteen controls, injected with nonpainful isotonic saline, increased quadricep strength by 7% (P less than .0001).
Common wisdom holds that pain diminishes muscle function, inhibits strength training, and may prevent rehabilitation in patients with knee problems, including osteoarthritis, but “no one has ever proven that is actually the case,” said lead study author Tina Sorensen, a doctoral candidate at the Institute of Sports Science and Clinical Biomechanics at the University of Southern Denmark in Odense.
The results suggest “maybe it's not that bad to exercise with pain, at least if it's not caused by inflammation”; perhaps they also hint at a role for induced pain in some settings, said Ms. Sorensen, who is a physiotherapist. The researchers said they are interested in seeing if their early results hold up in patients with actual knee problems.
Loads used in training were 80% of a given subject's maximum repetition strength, assessed weekly and without pain. Participants worked each set to the point of muscle fatigue, usually 8-12 repetitions, and rested a minute between sets. The groups were evenly matched, with no significant differences in height, body mass index, or baseline strength. There were 10 men in the pain group and 6 in the control group, but as with other factors, the difference was not statistically significant.
The injections (1 mL of saline under ultrasound guidance) came after a 10-minute warm-up on a stationary bicycle. The pain from the hypertonic shots diminished as subjects worked through their sets, starting on average at about 25 mm on the 100-mm visual analog pain scale and ending at about 10 mm. Strength was assessed weekly 30 minutes after training.
After 8 weeks, the right legs of subjects in the pain group were 24.6% stronger at 60 degrees of knee extension, 21.6% stronger at 120 degrees, and 19.6% at 180 degrees. Subjects in the control group were 7.5% stronger at 60 degrees of knee extension, 5.0% at 120 degrees, and 8.2% at 180 degrees.
“It could be that when you have pain, your type 1 muscle fibers [the endurance fibers,] are inhibited, and your type 2 [power and speed] fibers are easily recruited, which could explain why the pain group had the larger increase in muscle strength,” Ms. Sorensen said at the meeting, which was sponsored by the Osteoarthritis Research Society International.
Major Finding: After 8 weeks of strength training, subjects whose knees had been injected with a painful saline solution before each workout had quadriceps that were 22% stronger; the quadriceps of peers who didn't get painful injections were 7% stronger.
Data Source: Randomized, controlled trial involving 27 people.
Disclosures: Ms. Sorensen said she has no disclosures. The work was supported by the Association of Danish Physiotherapists.
SAN DIEGO – Induced knee pain appears to have improved strength training in a small, Danish randomized trial.
Researchers injected the right knee infrapatellar fat pads of 13 healthy subjects in their mid-20s with painful, hypertonic saline. Immediately afterward, participants did three sets of leg presses and knee extensions. After three sessions per week for 8 weeks, their right quadriceps were 22% stronger than at baseline. Fourteen controls, injected with nonpainful isotonic saline, increased quadricep strength by 7% (P less than .0001).
Common wisdom holds that pain diminishes muscle function, inhibits strength training, and may prevent rehabilitation in patients with knee problems, including osteoarthritis, but “no one has ever proven that is actually the case,” said lead study author Tina Sorensen, a doctoral candidate at the Institute of Sports Science and Clinical Biomechanics at the University of Southern Denmark in Odense.
The results suggest “maybe it's not that bad to exercise with pain, at least if it's not caused by inflammation”; perhaps they also hint at a role for induced pain in some settings, said Ms. Sorensen, who is a physiotherapist. The researchers said they are interested in seeing if their early results hold up in patients with actual knee problems.
Loads used in training were 80% of a given subject's maximum repetition strength, assessed weekly and without pain. Participants worked each set to the point of muscle fatigue, usually 8-12 repetitions, and rested a minute between sets. The groups were evenly matched, with no significant differences in height, body mass index, or baseline strength. There were 10 men in the pain group and 6 in the control group, but as with other factors, the difference was not statistically significant.
The injections (1 mL of saline under ultrasound guidance) came after a 10-minute warm-up on a stationary bicycle. The pain from the hypertonic shots diminished as subjects worked through their sets, starting on average at about 25 mm on the 100-mm visual analog pain scale and ending at about 10 mm. Strength was assessed weekly 30 minutes after training.
After 8 weeks, the right legs of subjects in the pain group were 24.6% stronger at 60 degrees of knee extension, 21.6% stronger at 120 degrees, and 19.6% at 180 degrees. Subjects in the control group were 7.5% stronger at 60 degrees of knee extension, 5.0% at 120 degrees, and 8.2% at 180 degrees.
“It could be that when you have pain, your type 1 muscle fibers [the endurance fibers,] are inhibited, and your type 2 [power and speed] fibers are easily recruited, which could explain why the pain group had the larger increase in muscle strength,” Ms. Sorensen said at the meeting, which was sponsored by the Osteoarthritis Research Society International.
Major Finding: After 8 weeks of strength training, subjects whose knees had been injected with a painful saline solution before each workout had quadriceps that were 22% stronger; the quadriceps of peers who didn't get painful injections were 7% stronger.
Data Source: Randomized, controlled trial involving 27 people.
Disclosures: Ms. Sorensen said she has no disclosures. The work was supported by the Association of Danish Physiotherapists.
SAN DIEGO – Induced knee pain appears to have improved strength training in a small, Danish randomized trial.
Researchers injected the right knee infrapatellar fat pads of 13 healthy subjects in their mid-20s with painful, hypertonic saline. Immediately afterward, participants did three sets of leg presses and knee extensions. After three sessions per week for 8 weeks, their right quadriceps were 22% stronger than at baseline. Fourteen controls, injected with nonpainful isotonic saline, increased quadricep strength by 7% (P less than .0001).
Common wisdom holds that pain diminishes muscle function, inhibits strength training, and may prevent rehabilitation in patients with knee problems, including osteoarthritis, but “no one has ever proven that is actually the case,” said lead study author Tina Sorensen, a doctoral candidate at the Institute of Sports Science and Clinical Biomechanics at the University of Southern Denmark in Odense.
The results suggest “maybe it's not that bad to exercise with pain, at least if it's not caused by inflammation”; perhaps they also hint at a role for induced pain in some settings, said Ms. Sorensen, who is a physiotherapist. The researchers said they are interested in seeing if their early results hold up in patients with actual knee problems.
Loads used in training were 80% of a given subject's maximum repetition strength, assessed weekly and without pain. Participants worked each set to the point of muscle fatigue, usually 8-12 repetitions, and rested a minute between sets. The groups were evenly matched, with no significant differences in height, body mass index, or baseline strength. There were 10 men in the pain group and 6 in the control group, but as with other factors, the difference was not statistically significant.
The injections (1 mL of saline under ultrasound guidance) came after a 10-minute warm-up on a stationary bicycle. The pain from the hypertonic shots diminished as subjects worked through their sets, starting on average at about 25 mm on the 100-mm visual analog pain scale and ending at about 10 mm. Strength was assessed weekly 30 minutes after training.
After 8 weeks, the right legs of subjects in the pain group were 24.6% stronger at 60 degrees of knee extension, 21.6% stronger at 120 degrees, and 19.6% at 180 degrees. Subjects in the control group were 7.5% stronger at 60 degrees of knee extension, 5.0% at 120 degrees, and 8.2% at 180 degrees.
“It could be that when you have pain, your type 1 muscle fibers [the endurance fibers,] are inhibited, and your type 2 [power and speed] fibers are easily recruited, which could explain why the pain group had the larger increase in muscle strength,” Ms. Sorensen said at the meeting, which was sponsored by the Osteoarthritis Research Society International.
Rigorous Exercise May Delay Hip Replacement
Major Finding: After going through a rigorous 3-month exercise program, 40% of patients with hip osteoarthritis (22) got a hip replacement within 3.5-6 years; 57% of their control group peers who did not go through the exercise program (31) got an artificial hip during the same period.
Data Source: Randomized controlled trial involving 109 patients.
Disclosures: The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no relevant financial disclosures.
SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized controlled trial.
Within the first 6 years after participating in the exercise program, 40% of patients (22) had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.
The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.
The message was “don't be afraid of your pain. It won't damage your cartilage” and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.
“We pushed them quite hard,” Dr. Fernandes said at the congress sponsored by the Osteoarthritis Research Society International.
They “had to exercise at 70%-80% of [their] maximum” for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.
In spring 2011 − 3.5-6 years after the exercise program, Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.
The results were “kind of surprising to us,” said senior author and physiotherapist May Arna Risberg, Ph.D., professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.
Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.
The two groups were evenly balanced, with no significant baseline differences in age, sex, joint space, Harris Hip Score, and self-reported pain and function.
The progression of radiographic osteoarthritis was also significantly worse in the patients who did not get supervised exercise. “The mechanism for how this works we don't know,” Dr. Risberg said.
Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, “we increased the load,” Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).
The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.
To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.
Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.
The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients' biomechanics to see if they correlate with the outcomes.
Major Finding: After going through a rigorous 3-month exercise program, 40% of patients with hip osteoarthritis (22) got a hip replacement within 3.5-6 years; 57% of their control group peers who did not go through the exercise program (31) got an artificial hip during the same period.
Data Source: Randomized controlled trial involving 109 patients.
Disclosures: The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no relevant financial disclosures.
SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized controlled trial.
Within the first 6 years after participating in the exercise program, 40% of patients (22) had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.
The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.
The message was “don't be afraid of your pain. It won't damage your cartilage” and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.
“We pushed them quite hard,” Dr. Fernandes said at the congress sponsored by the Osteoarthritis Research Society International.
They “had to exercise at 70%-80% of [their] maximum” for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.
In spring 2011 − 3.5-6 years after the exercise program, Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.
The results were “kind of surprising to us,” said senior author and physiotherapist May Arna Risberg, Ph.D., professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.
Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.
The two groups were evenly balanced, with no significant baseline differences in age, sex, joint space, Harris Hip Score, and self-reported pain and function.
The progression of radiographic osteoarthritis was also significantly worse in the patients who did not get supervised exercise. “The mechanism for how this works we don't know,” Dr. Risberg said.
Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, “we increased the load,” Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).
The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.
To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.
Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.
The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients' biomechanics to see if they correlate with the outcomes.
Major Finding: After going through a rigorous 3-month exercise program, 40% of patients with hip osteoarthritis (22) got a hip replacement within 3.5-6 years; 57% of their control group peers who did not go through the exercise program (31) got an artificial hip during the same period.
Data Source: Randomized controlled trial involving 109 patients.
Disclosures: The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no relevant financial disclosures.
SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized controlled trial.
Within the first 6 years after participating in the exercise program, 40% of patients (22) had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.
The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.
The message was “don't be afraid of your pain. It won't damage your cartilage” and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.
Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.
“We pushed them quite hard,” Dr. Fernandes said at the congress sponsored by the Osteoarthritis Research Society International.
They “had to exercise at 70%-80% of [their] maximum” for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.
In spring 2011 − 3.5-6 years after the exercise program, Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.
The results were “kind of surprising to us,” said senior author and physiotherapist May Arna Risberg, Ph.D., professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.
Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.
The two groups were evenly balanced, with no significant baseline differences in age, sex, joint space, Harris Hip Score, and self-reported pain and function.
The progression of radiographic osteoarthritis was also significantly worse in the patients who did not get supervised exercise. “The mechanism for how this works we don't know,” Dr. Risberg said.
Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, “we increased the load,” Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).
The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.
To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.
Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.
The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients' biomechanics to see if they correlate with the outcomes.