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Infliximab Break Safe for Most Early RA Patients
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients.
“Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole,” said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, they conducted a post hoc analysis of data from the Dutch Behandel Strategieen study, a multicenter, randomized, single-blind trial comparing four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The patients' average age was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After cessation of infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression in the year after discontinuation of infliximab, compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3 and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
“The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation,” the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients, but the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said.
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients.
“Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole,” said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, they conducted a post hoc analysis of data from the Dutch Behandel Strategieen study, a multicenter, randomized, single-blind trial comparing four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The patients' average age was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After cessation of infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression in the year after discontinuation of infliximab, compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3 and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
“The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation,” the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients, but the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said.
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients.
“Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole,” said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, they conducted a post hoc analysis of data from the Dutch Behandel Strategieen study, a multicenter, randomized, single-blind trial comparing four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The patients' average age was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After cessation of infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression in the year after discontinuation of infliximab, compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3 and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
“The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation,” the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients, but the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said.
FDA Approves Subcutaneous Form of RA Biologic
A subcutaneous formulation of abatacept that patients can inject themselves has been approved by the Food and Drug Administration, according to a statement issued July 29 by the manufacturer, Bristol-Myers Squibb.
Like the intravenous formulation, this preparation is approved for treatment of adults with moderate to severe rheumatoid arthritis and can be used as monotherapy or in combination with disease-modifying antirheumatic drugs, other than tumor necrosis factor antagonists. Intravenous abatacept is also approved as a treatment for children aged 6 years and older who have moderately to severely active polyarticular juvenile idiopathic arthritis. The subcutaneous formulation has not been studied in pediatric patients, according to the Bristol-Myers Squibb statement.
The IV formulation of abatacept, a selective T-cell costimulator modulator marketed as Orencia, was approved in 2005.
The approved dosing of subcutaneous abatacept is a fixed 125 mg dose, administered once a week after a single IV loading dose of approximately 10 mg/kg. Patients who are not able to receive an infusion may start weekly subcutaneous injections of abatacept, without the IV loading dose. Those switching from IV abatacept to subcutaneous therapy should administer the first subcutaneous dose instead of the next IV dose, according to the revised prescribing information.
The efficacy of subcutaneous therapy was similar to IV therapy in the ACQUIRE (Abatacept Comparison of Sub(Qu)cutaneous vs. Intravenous in Inadequate Responders to Methotrexate) study of almost 1,500 patients with moderately to severely active RA, most of whom had not had adequate responses to methotrexate alone, according to Bristol-Myers Squibb. The study, a phase III noninferiority study, compared treatment with subcutaneous abatacept plus methotrexate (after a single IV loading dose of about 10 mg/kg of abatacept) to IV abatacept plus methotrexate on days 1, 15, 29, and then every 4 weeks.
At 6 months, 76% of patients in both groups had achieved an ACR 20 response. ACR 50 and ACR 70 responses, as well as pain, physical, function, and global assessments for disease activity – and the safety profile –were also comparable between the two groups. Side effects included headache, nasopharyngitis, and upper respiratory tract infections; 2.6% of those who received the subcutaneous injections had injection-site reactions.
The rate of serious adverse events was 4.2% among those on subcutaneous (SC) abatacept and 4.9% of those in the IV group, and included serious infections (0.7% of those on subcutaneous dosing and 1.4% of those on the IV dose) and malignancies (under 1% in both groups).
Immunogenicity was seen in 1.1% of those on SC treatment and 2.3% of those on IV therapy, but this did not correlate with effects on pharmacokinetics, efficacy, or safety, the statement said.
The SC formulation will be marketed as Orencia SC and will be available in September, according to Bristol-Myers Squibb. The price is not yet available, a company spokesperson said.
A subcutaneous formulation of abatacept that patients can inject themselves has been approved by the Food and Drug Administration, according to a statement issued July 29 by the manufacturer, Bristol-Myers Squibb.
Like the intravenous formulation, this preparation is approved for treatment of adults with moderate to severe rheumatoid arthritis and can be used as monotherapy or in combination with disease-modifying antirheumatic drugs, other than tumor necrosis factor antagonists. Intravenous abatacept is also approved as a treatment for children aged 6 years and older who have moderately to severely active polyarticular juvenile idiopathic arthritis. The subcutaneous formulation has not been studied in pediatric patients, according to the Bristol-Myers Squibb statement.
The IV formulation of abatacept, a selective T-cell costimulator modulator marketed as Orencia, was approved in 2005.
The approved dosing of subcutaneous abatacept is a fixed 125 mg dose, administered once a week after a single IV loading dose of approximately 10 mg/kg. Patients who are not able to receive an infusion may start weekly subcutaneous injections of abatacept, without the IV loading dose. Those switching from IV abatacept to subcutaneous therapy should administer the first subcutaneous dose instead of the next IV dose, according to the revised prescribing information.
The efficacy of subcutaneous therapy was similar to IV therapy in the ACQUIRE (Abatacept Comparison of Sub(Qu)cutaneous vs. Intravenous in Inadequate Responders to Methotrexate) study of almost 1,500 patients with moderately to severely active RA, most of whom had not had adequate responses to methotrexate alone, according to Bristol-Myers Squibb. The study, a phase III noninferiority study, compared treatment with subcutaneous abatacept plus methotrexate (after a single IV loading dose of about 10 mg/kg of abatacept) to IV abatacept plus methotrexate on days 1, 15, 29, and then every 4 weeks.
At 6 months, 76% of patients in both groups had achieved an ACR 20 response. ACR 50 and ACR 70 responses, as well as pain, physical, function, and global assessments for disease activity – and the safety profile –were also comparable between the two groups. Side effects included headache, nasopharyngitis, and upper respiratory tract infections; 2.6% of those who received the subcutaneous injections had injection-site reactions.
The rate of serious adverse events was 4.2% among those on subcutaneous (SC) abatacept and 4.9% of those in the IV group, and included serious infections (0.7% of those on subcutaneous dosing and 1.4% of those on the IV dose) and malignancies (under 1% in both groups).
Immunogenicity was seen in 1.1% of those on SC treatment and 2.3% of those on IV therapy, but this did not correlate with effects on pharmacokinetics, efficacy, or safety, the statement said.
The SC formulation will be marketed as Orencia SC and will be available in September, according to Bristol-Myers Squibb. The price is not yet available, a company spokesperson said.
A subcutaneous formulation of abatacept that patients can inject themselves has been approved by the Food and Drug Administration, according to a statement issued July 29 by the manufacturer, Bristol-Myers Squibb.
Like the intravenous formulation, this preparation is approved for treatment of adults with moderate to severe rheumatoid arthritis and can be used as monotherapy or in combination with disease-modifying antirheumatic drugs, other than tumor necrosis factor antagonists. Intravenous abatacept is also approved as a treatment for children aged 6 years and older who have moderately to severely active polyarticular juvenile idiopathic arthritis. The subcutaneous formulation has not been studied in pediatric patients, according to the Bristol-Myers Squibb statement.
The IV formulation of abatacept, a selective T-cell costimulator modulator marketed as Orencia, was approved in 2005.
The approved dosing of subcutaneous abatacept is a fixed 125 mg dose, administered once a week after a single IV loading dose of approximately 10 mg/kg. Patients who are not able to receive an infusion may start weekly subcutaneous injections of abatacept, without the IV loading dose. Those switching from IV abatacept to subcutaneous therapy should administer the first subcutaneous dose instead of the next IV dose, according to the revised prescribing information.
The efficacy of subcutaneous therapy was similar to IV therapy in the ACQUIRE (Abatacept Comparison of Sub(Qu)cutaneous vs. Intravenous in Inadequate Responders to Methotrexate) study of almost 1,500 patients with moderately to severely active RA, most of whom had not had adequate responses to methotrexate alone, according to Bristol-Myers Squibb. The study, a phase III noninferiority study, compared treatment with subcutaneous abatacept plus methotrexate (after a single IV loading dose of about 10 mg/kg of abatacept) to IV abatacept plus methotrexate on days 1, 15, 29, and then every 4 weeks.
At 6 months, 76% of patients in both groups had achieved an ACR 20 response. ACR 50 and ACR 70 responses, as well as pain, physical, function, and global assessments for disease activity – and the safety profile –were also comparable between the two groups. Side effects included headache, nasopharyngitis, and upper respiratory tract infections; 2.6% of those who received the subcutaneous injections had injection-site reactions.
The rate of serious adverse events was 4.2% among those on subcutaneous (SC) abatacept and 4.9% of those in the IV group, and included serious infections (0.7% of those on subcutaneous dosing and 1.4% of those on the IV dose) and malignancies (under 1% in both groups).
Immunogenicity was seen in 1.1% of those on SC treatment and 2.3% of those on IV therapy, but this did not correlate with effects on pharmacokinetics, efficacy, or safety, the statement said.
The SC formulation will be marketed as Orencia SC and will be available in September, according to Bristol-Myers Squibb. The price is not yet available, a company spokesperson said.
Heart Disease Dogs Arthritis Patients
The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.
Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent myocardial infarction was shown to occur more often in RA patients than controls, and sudden death was also more likely in the RA patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).
In fact, RA is now considered by some experts to be equivalent to diabetes mellitus in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.
The European League Against Rheumatism (EULAR) has proposed that conventional cardiovascular risk models be multiplied by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).
This approach is not well validated and may not be widely used at this point, according to Dr. Bathon. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. Furthermore, it suggests that considering RA as a risk factor equivalent to diabetes mellitus – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.
She also said that a potential screening strategy involves yearly cardiovascular risk screening. The benefits of using imaging and biomarkers for screening are unclear, and no guidelines are currently in place. Some data suggest that the use of carotid ultrasound scans to look for plaques and to assess intima-media thickness – and the calculation of a coronary artery calcium score using CT – may be useful in patients older than 40 years.
As for potential management strategies, aspirin therapy might be useful but should be considered in the context of other medications the patient is taking.
Statins are also a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.
Definite treatment strategies for RA patients include weight management for overweight patients – which will help reduce inflammation – as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are also imperative, Dr. Bathon said.
She noted that conventional cardiovascular risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays an important role.
"We also have to think about ourselves," she said, referring to whether rheumatologists are aggressive enough in their management of cardiovascular risk in RA patients.
There is some question as to whether the increased risk in RA patients, compared with controls, is a result of less-aggressive treatment, she said.
Dr. Bathon had no disclosures relevant to her presentation.
The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.
Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent myocardial infarction was shown to occur more often in RA patients than controls, and sudden death was also more likely in the RA patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).
In fact, RA is now considered by some experts to be equivalent to diabetes mellitus in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.
The European League Against Rheumatism (EULAR) has proposed that conventional cardiovascular risk models be multiplied by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).
This approach is not well validated and may not be widely used at this point, according to Dr. Bathon. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. Furthermore, it suggests that considering RA as a risk factor equivalent to diabetes mellitus – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.
She also said that a potential screening strategy involves yearly cardiovascular risk screening. The benefits of using imaging and biomarkers for screening are unclear, and no guidelines are currently in place. Some data suggest that the use of carotid ultrasound scans to look for plaques and to assess intima-media thickness – and the calculation of a coronary artery calcium score using CT – may be useful in patients older than 40 years.
As for potential management strategies, aspirin therapy might be useful but should be considered in the context of other medications the patient is taking.
Statins are also a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.
Definite treatment strategies for RA patients include weight management for overweight patients – which will help reduce inflammation – as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are also imperative, Dr. Bathon said.
She noted that conventional cardiovascular risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays an important role.
"We also have to think about ourselves," she said, referring to whether rheumatologists are aggressive enough in their management of cardiovascular risk in RA patients.
There is some question as to whether the increased risk in RA patients, compared with controls, is a result of less-aggressive treatment, she said.
Dr. Bathon had no disclosures relevant to her presentation.
The jury is still out on just how cardiovascular risk should be screened and managed in rheumatoid arthritis patients, but it is clear that the risk is increased and must be addressed.
Patients with RA are known to have a lower probability of survival than do controls, and a major cause of excess death is from cardiovascular disease. In one study, silent myocardial infarction was shown to occur more often in RA patients than controls, and sudden death was also more likely in the RA patients (Arthritis Rheum. 2005;52:402-11). In another study, survival among patients with acute cardiac syndrome was substantially reduced in RA vs. non-RA patients (Ann. Rheum. Dis. 2006;65:348-53).
In fact, RA is now considered by some experts to be equivalent to diabetes mellitus in terms of the extent to which it confers cardiovascular risk, according to Dr. Joan Bathon, director of the division of rheumatology at Columbia University, New York.
The European League Against Rheumatism (EULAR) has proposed that conventional cardiovascular risk models be multiplied by 1.5 when risk is assessed in RA patients, said Dr. Bathon (Ann. Rheum. Dis. 2010;69:325-31).
This approach is not well validated and may not be widely used at this point, according to Dr. Bathon. But the proposal illustrates the importance of focusing on cardiovascular risk in RA patients. Furthermore, it suggests that considering RA as a risk factor equivalent to diabetes mellitus – at least for making decisions about LDL cholesterol goals – is a reasonable strategy, she said.
She also said that a potential screening strategy involves yearly cardiovascular risk screening. The benefits of using imaging and biomarkers for screening are unclear, and no guidelines are currently in place. Some data suggest that the use of carotid ultrasound scans to look for plaques and to assess intima-media thickness – and the calculation of a coronary artery calcium score using CT – may be useful in patients older than 40 years.
As for potential management strategies, aspirin therapy might be useful but should be considered in the context of other medications the patient is taking.
Statins are also a potential management tool, but questions remain about whether all RA patients should be treated regardless of LDL cholesterol level, Dr. Bathon said.
Definite treatment strategies for RA patients include weight management for overweight patients – which will help reduce inflammation – as well as exercise for all RA patients, because good quality muscle building will help restore insulin sensitivity and reduce fat depots that are the most inflammatory. Tight blood pressure control and tight RA control are also imperative, Dr. Bathon said.
She noted that conventional cardiovascular risk factors do not fully explain the excess risk in RA patients, and that inflammation probably plays an important role.
"We also have to think about ourselves," she said, referring to whether rheumatologists are aggressive enough in their management of cardiovascular risk in RA patients.
There is some question as to whether the increased risk in RA patients, compared with controls, is a result of less-aggressive treatment, she said.
Dr. Bathon had no disclosures relevant to her presentation.
Lost Productivity Chief Among Indirect Costs of Rheumatoid Arthritis
Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.
These findings, reported in the August issue of Annals of the Rheumatic Diseases, suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may indicate the need for earlier intervention.
Lost productivity figures large among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients’ ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.
To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) Study Group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).
First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007. Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient’s personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.
The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.
The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found. Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.
The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).
The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.
"We made a series of important observations," the researchers said. "One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start." The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.
Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.
"Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development," the researchers said.
The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.
Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.
These findings, reported in the August issue of Annals of the Rheumatic Diseases, suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may indicate the need for earlier intervention.
Lost productivity figures large among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients’ ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.
To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) Study Group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).
First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007. Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient’s personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.
The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.
The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found. Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.
The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).
The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.
"We made a series of important observations," the researchers said. "One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start." The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.
Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.
"Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development," the researchers said.
The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.
Patients with newly diagnosed but still untreated rheumatoid arthritis increase their use of sick leave and disability pension benefits, judging from findings from a Swedish study. Initiation of standard treatment halted but did not reverse this development.
These findings, reported in the August issue of Annals of the Rheumatic Diseases, suggest that the ability to work may be an important clinical measure when evaluating the needs of patients with RA, and may indicate the need for earlier intervention.
Lost productivity figures large among the indirect costs of rheumatoid arthritis. Yet, the only evidence of patients’ ability to work with RA comes from studies that were small or included limited or no history of sick leave. Some limited data come in the form of secondary findings from trials of RA treatments.
To try to fill in the gaps, Martin Neovius, Ph.D., of the Karolinska Institute in Stockholm, and his colleagues in the Anti-Rheumatic Therapies in Sweden (ARTIS) Study Group investigated the number of days of sick leave and disability taken by patients with RA – both before and after initiation of standard therapies (Ann. Rheum. Dis. 2011;70:1407-14).
First, they identified patients aged 19-60 years who were diagnosed with RA between 1999 and 2007. Data on when treatment was initiated came from the Swedish Rheumatology Quality Register. Next, they used each patient’s personal identification number to retrieve data on sick leave and disability pension from the Social Insurance Office database.
The researchers divided the patients into four cohorts: 2,796 patients who received nonbiologic disease-modifying anti-rheumatic drug (DMARD) monotherapy; 973 patients who received nonbiologic DMARD combination therapy; 1,600 patients with RA for less than 5 years who received biologic therapy; and 4,787 patients who received biologic agents regardless of RA duration.
The prevalence of sick leave and disability pension was lowest before the start of DMARD therapy, the researchers found. Specifically, 10% and 12% of patients received disability pension benefits during the year before starting DMARD monotherapy and combination therapy, respectively, and 43% of patients received benefits before starting biologic treatment.
The mean number of days of disability pension per year was 25 during the year before the start of DMARD monotherapy, 27 before the start of DMARD combination therapy, and 111 for biologic therapy. However, fewer days of sick leave were taken in the year before the start of biologic agents and DMARD monotherapy (mean 79 and 54 days, respectively) than before the start of DMARD combination therapy (105 days).
The mean number of monthly days of sick leave and disability pension increased in all cohorts in the year before treatment and peaked at 1 month after treatment began, the researchers said. After that first month following treatment, sick leave stabilized below the peak level, but disability pensions increased.
"We made a series of important observations," the researchers said. "One, irrespective of treatment type, initiators had on average a long history of gradual deterioration in work ability, although, as expected, the level of days off work was higher among patients selected for biological therapy than those starting a first nonbiological DMARD monotherapy. Two, irrespective of treatment type, patients selected for these treatments were characterized by a breakpoint in the deteriorating work ability following treatment start." The third lesson was that patients continued to use disability despite their increased ability to work, the authors reported.
Intensive treatment halted but did not reverse the deterioration of work ability, the researchers said. After initiation of treatment with biologic agents, the annual level of sick leave and disability pension was close to 200 days a year out of a maximum of 365, and more than 150 days for those who started on combination DMARD treatment.
"Given the increase observed already before treatment start, there is an obvious need to identify patients at risk of work ability deterioration much earlier than currently, and potentially break the development," the researchers said.
The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.
FROM ANNALS OF THE RHEUMATIC DISEASES
Major Finding: Sick leave and disability pension in Sweden increased rapidly in patients with rheumatoid arthritis before the initiation of therapy, which halted but did not reverse this development.
Data Source: Data obtained from the Swedish Rheumatology Quality Register and the Social Insurance Office database.
Disclosures: The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS run by the Swedish Society for Rheumatology. For the maintenance of this register, the Swedish Society for Rheumatology has received funding, independent of the conduct of these scientific analyses, from Abbott Laboratories, BMS, Roche, Schering-Plough, UCB, and Wyeth.
Entheses Seen on Ultrasound Can Accurately Predict Spondyloarthritis
A power Doppler ultrasound examination may provide the most accurate early diagnosis of spondyloarthritis, with a sensitivity of 76% and a specificity of 81% upon the visualization of at least one vascularized enthesis.
The finding may be particularly valuable to rheumatologists because the existing spondyloarthritis diagnostic criteria have, at best, a limited ability to accurately identify the disease in its earliest stages, Dr. Maria Antoinette D’Agostino and her colleagues wrote in the August issue of Annals of the Rheumatic Diseases.
Although the test itself is a "delicate technique," it is within the reach of most ultrasound technicians. "It can be performed reliably by sonographers with varying levels of experience followed by dedicated training," said Dr. D’Agostino of Versailles Saint-Quentin-en-Yveline (France) University.
The 2-year prospective cohort study comprised 118 patients with symptoms suggestive of spondyloarthritis. These included inflammatory back pain (48); arthritis or arthralgia (38); enthesitis or dactylitis (12) and HLA B27 plus acute anterior uveitis (20). Their median age was 40 years; the median disease duration at baseline was 2 years.
All patients underwent a standard clinical examination by a rheumatologist who was blinded to the diagnosis of the referring physician. All had provided a pelvic x-ray not more than 6 months old for the scoring of sacroiliitis; if the radiologic findings were equivocal or if there was persistent buttock pain, the patients underwent a pelvic CT scan. Those with past or present inflammatory back pain also underwent MRI.
Every patient had a power Doppler ultrasound examination of peripheral entheses by a sonographer who was blinded to the patients’ data. Areas examined included plantar fascia, Achilles tendon, patellar ligament on the patella apex, quadriceps femoris, gluteus medius tendon, and the common extensor and common flexor tendons on the lateral and medial epicondyle of the elbow.
Important findings included any morphologic or structural abnormalities and vascularization at bony insertion points. The study evaluated three criteria: any vascularized enthesis, the number of abnormal entheses, and the global ultrasound score.
The referring physician’s diagnosis was used as the clinical standard in evaluating ultrasound’s diagnostic capability; after 2 years, the patients were reevaluated for a final diagnosis, which the investigators then compared with the original diagnosis to compute ultrasound’s diagnostic capability. At the end of the follow-up period, patients were reclassified by their referring rheumatologist (51 diagnosed with SpA, 48 not diagnosed as SpA, and 19 unclassified).
In building the prediction model, the investigators examined the ultrasound findings in light of the final diagnoses. Ultrasound found at least one abnormal enthesis in 88 (75%) of the patients; the enthesis was vascularized in 56 of these patients. At least one vascularized enthesis occurred in 76% of those with an SpA diagnosis, 19% of those with a non-SpA diagnosis, and 42% of unclassified patients (Ann. Rheum. Dis. 2011;70:1433-40).
Ultrasound detected significantly more abnormal and vascularized entheses in SpA patients than in non-SpA patients. Those with a SpA diagnosis also had significantly higher ultrasound global scores than did the other groups.
Overall, two factors independently predicted a final diagnosis of SpA: Patients who had at least one vascularized enthesis on ultrasound were 12 times more likely to have a final diagnosis of SpA, and patients with an Amor criteria score of 6 or greater were nearly nine times more likely to have SpA than patients with a lower score.
Increasing the number of vascularized entheses to more than one did not improve the prediction model, nor did other diagnostic criteria, including the Berlin criteria and ASAS (Assessment of Spondyloarthritis Society) classification and diagnostic criteria.
Further analysis confirmed that the baseline presence of at least one vascularized enthesis predicted SpA at 2 years with a 76.5% sensitivity and an 81% specificity. If there were no vascularized entheses at baseline, SpA could still be predicted with a combination of ultrasound and positive Amor criteria score, the authors said; this method yielded a sensitivity of 90% for SpA and a specificity of 77%.
The study points out the diagnostic importance of enthesis vascularization in early SpA, the authors noted: "Strikingly, we confirmed that vascularization of the enthesis insertion by [ultrasound] is a landmark feature for SpA, even in suspected cases ... One vascularized enthesis was sufficient to predict a diagnosis of SpA, independent of the localization and the frequency of involvement."h
The study was supported by a grant from the French Society of Rheumatology. None of the authors had any financial disclosures.
A power Doppler ultrasound examination may provide the most accurate early diagnosis of spondyloarthritis, with a sensitivity of 76% and a specificity of 81% upon the visualization of at least one vascularized enthesis.
The finding may be particularly valuable to rheumatologists because the existing spondyloarthritis diagnostic criteria have, at best, a limited ability to accurately identify the disease in its earliest stages, Dr. Maria Antoinette D’Agostino and her colleagues wrote in the August issue of Annals of the Rheumatic Diseases.
Although the test itself is a "delicate technique," it is within the reach of most ultrasound technicians. "It can be performed reliably by sonographers with varying levels of experience followed by dedicated training," said Dr. D’Agostino of Versailles Saint-Quentin-en-Yveline (France) University.
The 2-year prospective cohort study comprised 118 patients with symptoms suggestive of spondyloarthritis. These included inflammatory back pain (48); arthritis or arthralgia (38); enthesitis or dactylitis (12) and HLA B27 plus acute anterior uveitis (20). Their median age was 40 years; the median disease duration at baseline was 2 years.
All patients underwent a standard clinical examination by a rheumatologist who was blinded to the diagnosis of the referring physician. All had provided a pelvic x-ray not more than 6 months old for the scoring of sacroiliitis; if the radiologic findings were equivocal or if there was persistent buttock pain, the patients underwent a pelvic CT scan. Those with past or present inflammatory back pain also underwent MRI.
Every patient had a power Doppler ultrasound examination of peripheral entheses by a sonographer who was blinded to the patients’ data. Areas examined included plantar fascia, Achilles tendon, patellar ligament on the patella apex, quadriceps femoris, gluteus medius tendon, and the common extensor and common flexor tendons on the lateral and medial epicondyle of the elbow.
Important findings included any morphologic or structural abnormalities and vascularization at bony insertion points. The study evaluated three criteria: any vascularized enthesis, the number of abnormal entheses, and the global ultrasound score.
The referring physician’s diagnosis was used as the clinical standard in evaluating ultrasound’s diagnostic capability; after 2 years, the patients were reevaluated for a final diagnosis, which the investigators then compared with the original diagnosis to compute ultrasound’s diagnostic capability. At the end of the follow-up period, patients were reclassified by their referring rheumatologist (51 diagnosed with SpA, 48 not diagnosed as SpA, and 19 unclassified).
In building the prediction model, the investigators examined the ultrasound findings in light of the final diagnoses. Ultrasound found at least one abnormal enthesis in 88 (75%) of the patients; the enthesis was vascularized in 56 of these patients. At least one vascularized enthesis occurred in 76% of those with an SpA diagnosis, 19% of those with a non-SpA diagnosis, and 42% of unclassified patients (Ann. Rheum. Dis. 2011;70:1433-40).
Ultrasound detected significantly more abnormal and vascularized entheses in SpA patients than in non-SpA patients. Those with a SpA diagnosis also had significantly higher ultrasound global scores than did the other groups.
Overall, two factors independently predicted a final diagnosis of SpA: Patients who had at least one vascularized enthesis on ultrasound were 12 times more likely to have a final diagnosis of SpA, and patients with an Amor criteria score of 6 or greater were nearly nine times more likely to have SpA than patients with a lower score.
Increasing the number of vascularized entheses to more than one did not improve the prediction model, nor did other diagnostic criteria, including the Berlin criteria and ASAS (Assessment of Spondyloarthritis Society) classification and diagnostic criteria.
Further analysis confirmed that the baseline presence of at least one vascularized enthesis predicted SpA at 2 years with a 76.5% sensitivity and an 81% specificity. If there were no vascularized entheses at baseline, SpA could still be predicted with a combination of ultrasound and positive Amor criteria score, the authors said; this method yielded a sensitivity of 90% for SpA and a specificity of 77%.
The study points out the diagnostic importance of enthesis vascularization in early SpA, the authors noted: "Strikingly, we confirmed that vascularization of the enthesis insertion by [ultrasound] is a landmark feature for SpA, even in suspected cases ... One vascularized enthesis was sufficient to predict a diagnosis of SpA, independent of the localization and the frequency of involvement."h
The study was supported by a grant from the French Society of Rheumatology. None of the authors had any financial disclosures.
A power Doppler ultrasound examination may provide the most accurate early diagnosis of spondyloarthritis, with a sensitivity of 76% and a specificity of 81% upon the visualization of at least one vascularized enthesis.
The finding may be particularly valuable to rheumatologists because the existing spondyloarthritis diagnostic criteria have, at best, a limited ability to accurately identify the disease in its earliest stages, Dr. Maria Antoinette D’Agostino and her colleagues wrote in the August issue of Annals of the Rheumatic Diseases.
Although the test itself is a "delicate technique," it is within the reach of most ultrasound technicians. "It can be performed reliably by sonographers with varying levels of experience followed by dedicated training," said Dr. D’Agostino of Versailles Saint-Quentin-en-Yveline (France) University.
The 2-year prospective cohort study comprised 118 patients with symptoms suggestive of spondyloarthritis. These included inflammatory back pain (48); arthritis or arthralgia (38); enthesitis or dactylitis (12) and HLA B27 plus acute anterior uveitis (20). Their median age was 40 years; the median disease duration at baseline was 2 years.
All patients underwent a standard clinical examination by a rheumatologist who was blinded to the diagnosis of the referring physician. All had provided a pelvic x-ray not more than 6 months old for the scoring of sacroiliitis; if the radiologic findings were equivocal or if there was persistent buttock pain, the patients underwent a pelvic CT scan. Those with past or present inflammatory back pain also underwent MRI.
Every patient had a power Doppler ultrasound examination of peripheral entheses by a sonographer who was blinded to the patients’ data. Areas examined included plantar fascia, Achilles tendon, patellar ligament on the patella apex, quadriceps femoris, gluteus medius tendon, and the common extensor and common flexor tendons on the lateral and medial epicondyle of the elbow.
Important findings included any morphologic or structural abnormalities and vascularization at bony insertion points. The study evaluated three criteria: any vascularized enthesis, the number of abnormal entheses, and the global ultrasound score.
The referring physician’s diagnosis was used as the clinical standard in evaluating ultrasound’s diagnostic capability; after 2 years, the patients were reevaluated for a final diagnosis, which the investigators then compared with the original diagnosis to compute ultrasound’s diagnostic capability. At the end of the follow-up period, patients were reclassified by their referring rheumatologist (51 diagnosed with SpA, 48 not diagnosed as SpA, and 19 unclassified).
In building the prediction model, the investigators examined the ultrasound findings in light of the final diagnoses. Ultrasound found at least one abnormal enthesis in 88 (75%) of the patients; the enthesis was vascularized in 56 of these patients. At least one vascularized enthesis occurred in 76% of those with an SpA diagnosis, 19% of those with a non-SpA diagnosis, and 42% of unclassified patients (Ann. Rheum. Dis. 2011;70:1433-40).
Ultrasound detected significantly more abnormal and vascularized entheses in SpA patients than in non-SpA patients. Those with a SpA diagnosis also had significantly higher ultrasound global scores than did the other groups.
Overall, two factors independently predicted a final diagnosis of SpA: Patients who had at least one vascularized enthesis on ultrasound were 12 times more likely to have a final diagnosis of SpA, and patients with an Amor criteria score of 6 or greater were nearly nine times more likely to have SpA than patients with a lower score.
Increasing the number of vascularized entheses to more than one did not improve the prediction model, nor did other diagnostic criteria, including the Berlin criteria and ASAS (Assessment of Spondyloarthritis Society) classification and diagnostic criteria.
Further analysis confirmed that the baseline presence of at least one vascularized enthesis predicted SpA at 2 years with a 76.5% sensitivity and an 81% specificity. If there were no vascularized entheses at baseline, SpA could still be predicted with a combination of ultrasound and positive Amor criteria score, the authors said; this method yielded a sensitivity of 90% for SpA and a specificity of 77%.
The study points out the diagnostic importance of enthesis vascularization in early SpA, the authors noted: "Strikingly, we confirmed that vascularization of the enthesis insertion by [ultrasound] is a landmark feature for SpA, even in suspected cases ... One vascularized enthesis was sufficient to predict a diagnosis of SpA, independent of the localization and the frequency of involvement."h
The study was supported by a grant from the French Society of Rheumatology. None of the authors had any financial disclosures.
FROM ANNALS OF THE RHEUMATIC DISEASES
Major Finding: One vascularized enthesis seen on ultrasound predicted SpA within 2 years with a sensitivity of 76% and a specificity of 81%. An ultrasound finding of a nonvascularized enthesis, combined with positive Amor criteria, predicted the disorder at 2 years with a sensitivity of 90% and a specificity of 77%.
Data Source: A prospective cohort study of 118 patients with symptoms suggestive of spondyloarthritis.
Disclosures: The study was supported by a grant from the French Society of Rheumatology. None of the authors had any financial disclosures.
Discontinuing Infliximab Can Benefit Early Rheumatoid Arthritis Patients
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients. The results were published in Annals of the Rheumatic Diseases.
"Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole," said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, the researchers conducted a post hoc analysis of data from the Dutch Behandel Strategieen (BeSt) study, a multicenter, randomized, single-blind trial that compared four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients from the BeSt study discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The average age of the patients was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After stopping infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) who were initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab treatment group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression during the year after discontinuation of infliximab compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3, and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
"The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation," the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients. But the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said. However, infliximab discontinuation must be considered on an individual basis, especially for patients with any of the independent risk factors, they added.
The study was funded in part by the Dutch College of Health Insurance Companies, Centocor, and Schering-Plough.
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients. The results were published in Annals of the Rheumatic Diseases.
"Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole," said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, the researchers conducted a post hoc analysis of data from the Dutch Behandel Strategieen (BeSt) study, a multicenter, randomized, single-blind trial that compared four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients from the BeSt study discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The average age of the patients was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After stopping infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) who were initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab treatment group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression during the year after discontinuation of infliximab compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3, and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
"The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation," the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients. But the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said. However, infliximab discontinuation must be considered on an individual basis, especially for patients with any of the independent risk factors, they added.
The study was funded in part by the Dutch College of Health Insurance Companies, Centocor, and Schering-Plough.
Approximately 80% of patients with early rheumatoid arthritis can discontinue infliximab for at least 1 year with no ill effects, according to data from 104 patients. The results were published in Annals of the Rheumatic Diseases.
"Even temporary cessation can benefit both the individual patient and, given the high costs of TNF blockers, society as a whole," said Dr. M. van den Broek of Leiden University Medical Center, the Netherlands, and colleagues.
To determine the duration of decreased disease activity after discontinuing infliximab, the researchers conducted a post hoc analysis of data from the Dutch Behandel Strategieen (BeSt) study, a multicenter, randomized, single-blind trial that compared four treatment strategies in RA patients who had not previously received disease-modifying antirheumatic drugs (DMARDs).
In the post hoc analysis, 104 adult RA patients from the BeSt study discontinued infliximab when their disease activity score (DAS) was 2.4 or less for 6 months. The follow-up period ranged from 14 to 103 months, with a median of 7 years. The average age of the patients was 56 years, and 65% were women (Ann. Rheum. Dis. 2011;70:1389-94).
After stopping infliximab, the DAS remained at 2.4 or less in 43 of 77 patients (56%) who were initially treated with infliximab and in 11 of 27 patients (41%) who were in a delayed infliximab treatment group.
In 50 patients (34 from the initial infliximab treatment group and 16 from the delayed infliximab treatment group), the DAS increased above 2.4 over a median of 17 months, and infliximab was reintroduced. But 27 of the 34 patients in the initial treatment group and 15 of the 16 patients in the delayed treatment group (84% overall) regained a DAS of 2.4 or less within 3 months of reintroducing infliximab, the researchers noted.
Radiographs of joints before and after discontinuation of infliximab were available for 90 patients. These images showed no increase in joint damage progression during the year after discontinuation of infliximab compared with the previous year.
At the time of infliximab cessation, the mean DAS was 1.3, and the median symptom duration was 23 months. The median infliximab treatment was 11 months.
Independent risk factors for infliximab reintroduction were identified as being treatment duration of 18 months or longer, the presence of a shared epitope, and smoking, judging from findings from a multivariate analysis.
"The rate of serious infections was higher after the reintroduction of infliximab compared with during the initial treatment period or the period of infliximab cessation," the researchers noted. But the difference could reflect patient selection, longer duration of symptoms, or more severe RA, they said.
The study was limited in part by patient selection and by the lack of shared epitope data for all patients. But the findings suggest that infliximab can be discontinued for at least 1 year in 80% of early RA patients, the researchers said. However, infliximab discontinuation must be considered on an individual basis, especially for patients with any of the independent risk factors, they added.
The study was funded in part by the Dutch College of Health Insurance Companies, Centocor, and Schering-Plough.
FROM ANNALS OF THE RHEUMATIC DISEASES
Major Finding: Approximately 80% of adults with early rheumatoid arthritis can discontinue infliximab for at least a year with no severe adverse effects.
Data Source: A post hoc analysis of 104 adults with early RA from the Dutch Behandel Strategieen (BeSt) study.
Disclosures: The study was funded in part by the Dutch College of Health Insurance Companies, Centocor, and Schering-Plough.
HLA-B27 Positivity Strongest Predictor of TNF-Inhibitor Response in Ankylosing Spondylitis
LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.
Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.
"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.
"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.
Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.
NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.
ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.
Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).
Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).
Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).
The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.
For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).
Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).
Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.
However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."
Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.
LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.
Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.
"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.
"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.
Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.
NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.
ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.
Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).
Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).
Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).
The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.
For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).
Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).
Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.
However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."
Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.
LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.
Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.
"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.
"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.
Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.
NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.
ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.
Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).
Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).
Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).
The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.
For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).
Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).
Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.
However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."
Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.
FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY
Major Finding: The odds ratio for patients who were HLA-B27 positive and achieved ASDAS major improvement (greater than or equal to 2.0) at 3 months was 6.72, compared with those who were not (95% CI, 1.33-33.87; P = .02).
Data Source: Longitudinal, observational study of 171 patients with AS who were treated with an anti-TNF agent for the first time and were enrolled in NOR-DMARD, a register of adult patients with inflammatory arthropathies who were treated at five rheumatology centers in Norway.
Disclosures: Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.
COPD Prevalence Doubled in Rheumatoid Arthritis
LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.
In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).
Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.
"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.
"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.
Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.
COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).
Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.
Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.
Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.
"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).
The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).
"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.
NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.
LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.
In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).
Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.
"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.
"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.
Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.
COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).
Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.
Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.
Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.
"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).
The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).
"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.
NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.
LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.
In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).
Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.
"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.
"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.
Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.
COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).
Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.
Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.
Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.
"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).
The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).
"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.
NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.
FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY
Major Finding: COPD was a comorbid condition in 8.9% of patients with RA compared with 4.4% of controls from the general population in one study (P less than .001), with 7.3% of the Norfolk Arthritis Register study population also found to have the respiratory disease.
Data Source: A case-control study of more than 30,000 individuals with or without rheumatoid arthritis and data from a 15-year follow up of 435 patients with inflammatory polyarthritis or RA in the Norfolk Arthritis Register.
Disclosures: NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.
Rheumatoid Arthritis Patients Not Receiving Proper Cardioprotective Medications
LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.
Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.
Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.
The increased risk of cardiovascular disease in RA patients is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.
"What’s not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients," Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the annual European Congress of Rheumatology.
To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.
The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.
At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.
Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.
Commenting on the findings in an interview, Dr. Lindhardsen conceded that this data raises more questions than it answers. For one thing, it’s not known what medications patients were taking before they had their heart attack, which could influence the findings.
Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.
Speaking at a press conference, Dr. Schett said that "the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this."
Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).
With regard to this post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient’s long-term care to ensure that standard cardioprotective medications are being used.
"We have quantitative data. Now we need more qualitative data," Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.
Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.
LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.
Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.
Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.
The increased risk of cardiovascular disease in RA patients is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.
"What’s not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients," Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the annual European Congress of Rheumatology.
To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.
The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.
At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.
Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.
Commenting on the findings in an interview, Dr. Lindhardsen conceded that this data raises more questions than it answers. For one thing, it’s not known what medications patients were taking before they had their heart attack, which could influence the findings.
Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.
Speaking at a press conference, Dr. Schett said that "the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this."
Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).
With regard to this post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient’s long-term care to ensure that standard cardioprotective medications are being used.
"We have quantitative data. Now we need more qualitative data," Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.
Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.
LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.
Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.
Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.
The increased risk of cardiovascular disease in RA patients is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.
"What’s not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients," Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the annual European Congress of Rheumatology.
To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.
The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.
At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.
Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.
Commenting on the findings in an interview, Dr. Lindhardsen conceded that this data raises more questions than it answers. For one thing, it’s not known what medications patients were taking before they had their heart attack, which could influence the findings.
Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.
Speaking at a press conference, Dr. Schett said that "the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this."
Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).
With regard to this post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient’s long-term care to ensure that standard cardioprotective medications are being used.
"We have quantitative data. Now we need more qualitative data," Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.
Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.
FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY
Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.
Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.
Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.
Rheumatoid Arthritis Incidence Rises With Age, Peaks During 70s
LONDON – The incidence of rheumatoid arthritis rises with age in both men and women and shows the biggest jump during the sixth decade of life, when the incidence among adults in their 50s nearly doubles compared with those in their 40s, based on findings from an analysis of about 10,000 Swedish patients diagnosed for the first time during 2006-2008.
The nationwide data also showed that peak rheumatoid arthritis (RA) incidence occurs among men and women in their 70s, with a new onset rate of at least 73 cases per 100,000 population annually, Jonas Eriksson said at the Annual European Congress of Rheumatology.
The nationwide Swedish data that allowed analysis of about 10,000 cases far exceeded the scope of previous incidence estimates, enabling Mr. Eriksson and his associates in the clinical epidemiology unit at the Karolinska Institute, Stockholm, to estimate incidence rates by age and sex. They used data collected by the Swedish Rheumatology Quality Register, the National Patient Register, and the Prescribed Drug Register.
To assess incident RA cases they used three different definitions of new-onset disease. The most restrictive definition involved patients who met all of five separate defining criteria: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register with a RA diagnosis during 2006-2008; at least one visit to a rheumatology or internal medicine department; at least two visits with a diagnosis of RA during 2006-2008; a second visit with a RA diagnosis within 1 year after a first visit; and exclusion of patients treated with a disease-modifying antirheumatic drug more than 6 months before the first visit with a RA diagnosis, pain in joints, or an unspecified diagnosis.
Applying these criteria to the databases for 2006-2008 identified 7,953 patients with a presumed first-time diagnosis of RA, which resulted in a calculated incidence rate of 35 cases/100,000 population per year. Broken down by gender, the rates were 22 cases/100,000 in men and 48 cases/100,000 in women. Mr. Eriksson also reported incidence rates among men and women broken down by age. The peak new-onset rates occurred in people aged 70-79 years, with rates of 60 cases/100,000 per year among men and 86 cases/100,000 per year in women.
To further broaden the analysis, the researchers calculated incidence rates using two less stringent definitions. They applied a "medium" definition that eliminated the exclusion portion of their initial, strict definition. This identified 9,133 new-onset cases during the 3 years studied, with an overall incidence rate of 41 cases/100,000 per year and rates of 25 cases/100,000 per year in men and 55 cases/100,000 per year in women.
A third, "liberal" definition of RA limited the identifying criteria to the first two elements from the original list of five: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register during 2006-2008; and at least one visit to a rheumatology or internal medicine department. This identified 11,715 new-onset cases in 2006-2008, an overall rate of 52/100,000 per year, with rates of 33/100,000 per year in men and 71/100,000 per year in women, Mr. Eriksson said.
The range of overall annual incidence rates they calculated – 35/100,000, 41/100,000, and 52/100,00 – collectively matched the annual incidence rates in previously reported studies of much smaller numbers of patients in Sweden, the United States, and Finland with newly diagnosed RA, he noted.
Mr. Eriksson said that he had no disclosures.
LONDON – The incidence of rheumatoid arthritis rises with age in both men and women and shows the biggest jump during the sixth decade of life, when the incidence among adults in their 50s nearly doubles compared with those in their 40s, based on findings from an analysis of about 10,000 Swedish patients diagnosed for the first time during 2006-2008.
The nationwide data also showed that peak rheumatoid arthritis (RA) incidence occurs among men and women in their 70s, with a new onset rate of at least 73 cases per 100,000 population annually, Jonas Eriksson said at the Annual European Congress of Rheumatology.
The nationwide Swedish data that allowed analysis of about 10,000 cases far exceeded the scope of previous incidence estimates, enabling Mr. Eriksson and his associates in the clinical epidemiology unit at the Karolinska Institute, Stockholm, to estimate incidence rates by age and sex. They used data collected by the Swedish Rheumatology Quality Register, the National Patient Register, and the Prescribed Drug Register.
To assess incident RA cases they used three different definitions of new-onset disease. The most restrictive definition involved patients who met all of five separate defining criteria: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register with a RA diagnosis during 2006-2008; at least one visit to a rheumatology or internal medicine department; at least two visits with a diagnosis of RA during 2006-2008; a second visit with a RA diagnosis within 1 year after a first visit; and exclusion of patients treated with a disease-modifying antirheumatic drug more than 6 months before the first visit with a RA diagnosis, pain in joints, or an unspecified diagnosis.
Applying these criteria to the databases for 2006-2008 identified 7,953 patients with a presumed first-time diagnosis of RA, which resulted in a calculated incidence rate of 35 cases/100,000 population per year. Broken down by gender, the rates were 22 cases/100,000 in men and 48 cases/100,000 in women. Mr. Eriksson also reported incidence rates among men and women broken down by age. The peak new-onset rates occurred in people aged 70-79 years, with rates of 60 cases/100,000 per year among men and 86 cases/100,000 per year in women.
To further broaden the analysis, the researchers calculated incidence rates using two less stringent definitions. They applied a "medium" definition that eliminated the exclusion portion of their initial, strict definition. This identified 9,133 new-onset cases during the 3 years studied, with an overall incidence rate of 41 cases/100,000 per year and rates of 25 cases/100,000 per year in men and 55 cases/100,000 per year in women.
A third, "liberal" definition of RA limited the identifying criteria to the first two elements from the original list of five: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register during 2006-2008; and at least one visit to a rheumatology or internal medicine department. This identified 11,715 new-onset cases in 2006-2008, an overall rate of 52/100,000 per year, with rates of 33/100,000 per year in men and 71/100,000 per year in women, Mr. Eriksson said.
The range of overall annual incidence rates they calculated – 35/100,000, 41/100,000, and 52/100,00 – collectively matched the annual incidence rates in previously reported studies of much smaller numbers of patients in Sweden, the United States, and Finland with newly diagnosed RA, he noted.
Mr. Eriksson said that he had no disclosures.
LONDON – The incidence of rheumatoid arthritis rises with age in both men and women and shows the biggest jump during the sixth decade of life, when the incidence among adults in their 50s nearly doubles compared with those in their 40s, based on findings from an analysis of about 10,000 Swedish patients diagnosed for the first time during 2006-2008.
The nationwide data also showed that peak rheumatoid arthritis (RA) incidence occurs among men and women in their 70s, with a new onset rate of at least 73 cases per 100,000 population annually, Jonas Eriksson said at the Annual European Congress of Rheumatology.
The nationwide Swedish data that allowed analysis of about 10,000 cases far exceeded the scope of previous incidence estimates, enabling Mr. Eriksson and his associates in the clinical epidemiology unit at the Karolinska Institute, Stockholm, to estimate incidence rates by age and sex. They used data collected by the Swedish Rheumatology Quality Register, the National Patient Register, and the Prescribed Drug Register.
To assess incident RA cases they used three different definitions of new-onset disease. The most restrictive definition involved patients who met all of five separate defining criteria: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register with a RA diagnosis during 2006-2008; at least one visit to a rheumatology or internal medicine department; at least two visits with a diagnosis of RA during 2006-2008; a second visit with a RA diagnosis within 1 year after a first visit; and exclusion of patients treated with a disease-modifying antirheumatic drug more than 6 months before the first visit with a RA diagnosis, pain in joints, or an unspecified diagnosis.
Applying these criteria to the databases for 2006-2008 identified 7,953 patients with a presumed first-time diagnosis of RA, which resulted in a calculated incidence rate of 35 cases/100,000 population per year. Broken down by gender, the rates were 22 cases/100,000 in men and 48 cases/100,000 in women. Mr. Eriksson also reported incidence rates among men and women broken down by age. The peak new-onset rates occurred in people aged 70-79 years, with rates of 60 cases/100,000 per year among men and 86 cases/100,000 per year in women.
To further broaden the analysis, the researchers calculated incidence rates using two less stringent definitions. They applied a "medium" definition that eliminated the exclusion portion of their initial, strict definition. This identified 9,133 new-onset cases during the 3 years studied, with an overall incidence rate of 41 cases/100,000 per year and rates of 25 cases/100,000 per year in men and 55 cases/100,000 per year in women.
A third, "liberal" definition of RA limited the identifying criteria to the first two elements from the original list of five: a first-ever inpatient visit, a specialist outpatient visit, or inclusion in the Swedish Rheumatology Quality Register during 2006-2008; and at least one visit to a rheumatology or internal medicine department. This identified 11,715 new-onset cases in 2006-2008, an overall rate of 52/100,000 per year, with rates of 33/100,000 per year in men and 71/100,000 per year in women, Mr. Eriksson said.
The range of overall annual incidence rates they calculated – 35/100,000, 41/100,000, and 52/100,00 – collectively matched the annual incidence rates in previously reported studies of much smaller numbers of patients in Sweden, the United States, and Finland with newly diagnosed RA, he noted.
Mr. Eriksson said that he had no disclosures.
FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY
Major Finding: The incidence rate of newly diagnosed rheumatoid arthritis rises with age, peaking among people in their 70s with an incidence of 73 new cases per 100,000 population annually.
Data Source: Review of Swedish national patient registers for 2006-2008, which identified about 10,000 newly diagnosed cases of RA.
Disclosures: Mr. Eriksson said he had no disclosures.