Rheumatoid Arthritis

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University, Portland, said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530–9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

The researchers had no conflicts to disclose.

On average, the patients spent 13 minutes on seated meditation.

Source ©BRANDXPICTURES

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University, Portland, said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530–9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

The researchers had no conflicts to disclose.

On average, the patients spent 13 minutes on seated meditation.

Source ©BRANDXPICTURES

Women with fibromyalgia who participated in an 8-week yoga program reported significant improvements on measures of fibromyalgia symptoms and function, based on data from a pilot study of 53 women.

The positive findings have become the basis of a grant proposal to the National Institutes of Health to fund a larger clinical trial, said lead investigator James Carson, Ph.D.

Many fibromyalgia patients find standard medical care ineffective for reducing their symptoms, including pain and fatigue, Dr. Carson of Oregon Health and Science University, Portland, said in an interview.

More effective treatments for fibromyalgia are needed, said Dr. Carson. “Exercise is often prescribed for fibromyalgia, but for many patients it is hard to find an exercise program that is tolerable for them. Yoga poses done in a gentle way may be a good option,” he said.

Dr. Carson and colleagues randomized 53 women who met the American College of Rheumatology criteria for fibromyalgia in an 8-week Yoga of Awareness program (25 women) or standard care (28 women). The program consisted of gentle yoga poses, modified as needed to accommodate conditions such as knee osteoarthritis or carpal tunnel syndrome (Pain 2010;151:530–9).

The primary outcome measure was the total score on the Fibromyalgia Impact Questionnaire Revised (FIQR). After 8 weeks, the mean FIQR total score dropped from 48.32 at baseline to 35.49 in the yoga group (a statistically significant difference), compared with a change from 49.26 at baseline to 48.69 in the control group. More than half (56%) of the yoga group had at least a 30% reduction in overall FIQR scores, which is slightly more than twice the 14% reduction that is recommended to show clinical significance, the researchers noted. In addition, 50% of patients in the yoga group had at least a 30% reduction in the pain subscale of the FIQR.

The Patient Global Impression of Change (PGIC) scale scores for overall improvement in fibromyalgia symptoms were significantly higher in the yoga group vs. the control group (5.05 vs. 3.69). The PGIC was measured only once, at the end of the study. As part of the PGIC, approximately 90% of the patients in the yoga group reported feeling “a little better,” “much better,” or “very much better,” compared with 19% of the controls.

The average age of the participants was 54 years, and 68% had been symptomatic for more than 10 years. Patients who were already engaged in a yoga practice, those who were too disabled for meaningful participation in the yoga program, and those who were scheduled for elective surgery were excluded from the study.

“The most surprising finding for us was that most patients became so fully engaged in the home yoga practices they were assigned,” Dr. Carson said. On average, the patients spent 40 minutes practicing yoga at home, including about 19 minutes of postures, 13 minutes of seated meditation, and 8 minutes of breathing exercises. Those who practiced more had better results on several of the study outcomes, he noted.

“This finding suggests that yoga practices, if taught in a tailored, accessible manner, are not only well tolerated and effective; they are practiced with an unexpected degree of enthusiasm,” he said.

The results also showed that patients in the yoga group were more likely to use positive pain-management strategies such as problem solving, religion, acceptance, and relaxation, and less likely to resort to negative pain-management strategies such as self-isolation, disengagement, and catastrophizing.

“We are preparing a grant proposal to the National Institutes of Health to fund a larger clinical trial that will include comparison with another active treatment, so that we can make sure that the improvements seen in this first study can be reliably replicated in another group of patients, and that the improvements are not attributable to simply receiving extra attention from caregivers or to a placebo effect,” Dr. Carson said.

The researchers had no conflicts to disclose.

On average, the patients spent 13 minutes on seated meditation.

Source ©BRANDXPICTURES

Montreal — Personality and attitude play a major role in shaping a patient's experience of chronic pain, and understanding this dynamic may help physicians overcome obstacles in treating some of their unresponsive patients, according to Michael Sullivan, Ph.D.

In fact, in recent studies, catastrophizing has emerged as “the most powerful psychological predictor of problematic pain outcomes,” said Dr. Sullivan, professor of psychology, medicine, and neurology at McGill University in Montreal.

In the context of pain, catastrophizing is defined as the tendency to worry and focus on the pain. Individuals who score high on the Pain Catastrophizing Scale (PCS), which was developed by Dr. Sullivan in 1995, tend to magnify and ruminate over their symptoms while feeling helpless about addressing them. “These individuals have an excessively alarmist attitude towards their pain and seem to have a lot more difficulty dealing with it,” he said at the meeting.

In the office setting, chronic pain patients who catastrophize “display more pain behavior such as holding, rubbing, guarding, as well as vocalizations such as moans and sighs,” he said at the meeting, which was sponsored by the International Association for the Study of Pain.

“Research shows that not only are catastrophizers going to have more difficulty in pain situations, they are also going to respond less well to the interventions that we offer them,” he said. In studies, Dr. Sullivan and his colleagues have shown that, compared with non-catastrophizers, catastrophizers are at greater risk of chronic pain following knee arthroplasty (Pain Res. Manag. 2008;13:335–41) and have more difficulty returning to work after whiplash injuries (J. Occup. Rehabil. 2007;17:305–15).

For patients whose chronic pain stems from an accident, perceptions of injustice also are common and can be expressed as anger or noncompliance. “Some of our recent research [Pain 2009;145:325–31] shows that perceptions of injustice are often associated with prolonged disability following a pain-related injury,” he said. For the treating physician, “validation techniques can be useful in reducing the negative impact of the catastrophizing patient's perceptions of injustice.”

By identifying catastrophizers early, physicians can avoid pitfalls that contribute to treatment failure in chronic pain. “There are some very concrete ways in which physicians could be reacting differently with these patients” to make patient management easier, he pointed out.

First and foremost, catastrophizers need to express their suffering and anxiety. “This person does have a story to tell and they need someone to listen. By not listening properly to that story initially, you are going to hear it again every time the patient comes, because the patient is going to feel that the doctor doesn't understand. So, increasing the time you initially spend with the patient can save a lot of headaches further down the line,” Dr. Sullivan explained.

Active listening has even been shown to reduce a patient's perception of pain, at least in the context of acute symptoms, said Dr. Sullivan, who has published several studies showing that allowing catastrophizers to disclose their fear and worry prior to routine dental hygiene procedures can reduce their perception of pain by as much as 50% (J. Indiana Dent. Assoc. 2000–2001;79:16–9; and Pain 1999;79:155–63).

Although a patient's basic personality is a challenge for physicians to work around, attitude – which is also an extremely powerful modifier of pain – is somewhat easier to mold, suggested Stefaan Van Damme, Ph.D., of the department of experimental clinical health and psychology at Ghent (Belgium) University.

In approaching pain control as a goal, chronic pain patients fall into two distinct categories: those who try to overcome it (assimilators) and those who accept it (accommodators). Both attitudes can be helpful or harmful, depending on how realistic pain control is for a particular patient, he said at the meeting.

“When pain is controllable, assimilative coping works. But when it is not controllable it can be maladaptive because it can exacerbate catastrophizing, hypervigilance, and distress,” he said. In a study, he demonstrated that, when attempts to avoid pain are unsuccessful, “individuals persist in their avoidance attempts, try harder, and narrow their focus of attention upon the problem to be solved” (Pain 2008;137:631–9).

Helping patients shift their focus from fighting to accepting their pain is particularly tricky for physicians, commented Dr. Sullivan, who is a psychologist. “I only get sent the patients when their pain has been long-standing. The concept of acceptance works when the pain has been there for 5 years,” he explained, “but for new-onset pain, acceptance is not the message that should be given by the doctor. This should only come up after we've offered everything else we can offer.”

Physicians should also be aware of their own personal psychology when dealing with catastrophizing patients, because catastrophizing personalities are not confined to the patient world. Physicians who are catastrophizers may inadvertently increase a patient's perception of suffering. “Some of our research suggests that if you're a catastrophizer you see 30% more pain in these individuals,” he said.

The speakers did not declare any conflicts of interest.

Montreal — Personality and attitude play a major role in shaping a patient's experience of chronic pain, and understanding this dynamic may help physicians overcome obstacles in treating some of their unresponsive patients, according to Michael Sullivan, Ph.D.

In fact, in recent studies, catastrophizing has emerged as “the most powerful psychological predictor of problematic pain outcomes,” said Dr. Sullivan, professor of psychology, medicine, and neurology at McGill University in Montreal.

In the context of pain, catastrophizing is defined as the tendency to worry and focus on the pain. Individuals who score high on the Pain Catastrophizing Scale (PCS), which was developed by Dr. Sullivan in 1995, tend to magnify and ruminate over their symptoms while feeling helpless about addressing them. “These individuals have an excessively alarmist attitude towards their pain and seem to have a lot more difficulty dealing with it,” he said at the meeting.

In the office setting, chronic pain patients who catastrophize “display more pain behavior such as holding, rubbing, guarding, as well as vocalizations such as moans and sighs,” he said at the meeting, which was sponsored by the International Association for the Study of Pain.

“Research shows that not only are catastrophizers going to have more difficulty in pain situations, they are also going to respond less well to the interventions that we offer them,” he said. In studies, Dr. Sullivan and his colleagues have shown that, compared with non-catastrophizers, catastrophizers are at greater risk of chronic pain following knee arthroplasty (Pain Res. Manag. 2008;13:335–41) and have more difficulty returning to work after whiplash injuries (J. Occup. Rehabil. 2007;17:305–15).

For patients whose chronic pain stems from an accident, perceptions of injustice also are common and can be expressed as anger or noncompliance. “Some of our recent research [Pain 2009;145:325–31] shows that perceptions of injustice are often associated with prolonged disability following a pain-related injury,” he said. For the treating physician, “validation techniques can be useful in reducing the negative impact of the catastrophizing patient's perceptions of injustice.”

By identifying catastrophizers early, physicians can avoid pitfalls that contribute to treatment failure in chronic pain. “There are some very concrete ways in which physicians could be reacting differently with these patients” to make patient management easier, he pointed out.

First and foremost, catastrophizers need to express their suffering and anxiety. “This person does have a story to tell and they need someone to listen. By not listening properly to that story initially, you are going to hear it again every time the patient comes, because the patient is going to feel that the doctor doesn't understand. So, increasing the time you initially spend with the patient can save a lot of headaches further down the line,” Dr. Sullivan explained.

Active listening has even been shown to reduce a patient's perception of pain, at least in the context of acute symptoms, said Dr. Sullivan, who has published several studies showing that allowing catastrophizers to disclose their fear and worry prior to routine dental hygiene procedures can reduce their perception of pain by as much as 50% (J. Indiana Dent. Assoc. 2000–2001;79:16–9; and Pain 1999;79:155–63).

Although a patient's basic personality is a challenge for physicians to work around, attitude – which is also an extremely powerful modifier of pain – is somewhat easier to mold, suggested Stefaan Van Damme, Ph.D., of the department of experimental clinical health and psychology at Ghent (Belgium) University.

In approaching pain control as a goal, chronic pain patients fall into two distinct categories: those who try to overcome it (assimilators) and those who accept it (accommodators). Both attitudes can be helpful or harmful, depending on how realistic pain control is for a particular patient, he said at the meeting.

“When pain is controllable, assimilative coping works. But when it is not controllable it can be maladaptive because it can exacerbate catastrophizing, hypervigilance, and distress,” he said. In a study, he demonstrated that, when attempts to avoid pain are unsuccessful, “individuals persist in their avoidance attempts, try harder, and narrow their focus of attention upon the problem to be solved” (Pain 2008;137:631–9).

Helping patients shift their focus from fighting to accepting their pain is particularly tricky for physicians, commented Dr. Sullivan, who is a psychologist. “I only get sent the patients when their pain has been long-standing. The concept of acceptance works when the pain has been there for 5 years,” he explained, “but for new-onset pain, acceptance is not the message that should be given by the doctor. This should only come up after we've offered everything else we can offer.”

Physicians should also be aware of their own personal psychology when dealing with catastrophizing patients, because catastrophizing personalities are not confined to the patient world. Physicians who are catastrophizers may inadvertently increase a patient's perception of suffering. “Some of our research suggests that if you're a catastrophizer you see 30% more pain in these individuals,” he said.

The speakers did not declare any conflicts of interest.

Montreal — Personality and attitude play a major role in shaping a patient's experience of chronic pain, and understanding this dynamic may help physicians overcome obstacles in treating some of their unresponsive patients, according to Michael Sullivan, Ph.D.

In fact, in recent studies, catastrophizing has emerged as “the most powerful psychological predictor of problematic pain outcomes,” said Dr. Sullivan, professor of psychology, medicine, and neurology at McGill University in Montreal.

In the context of pain, catastrophizing is defined as the tendency to worry and focus on the pain. Individuals who score high on the Pain Catastrophizing Scale (PCS), which was developed by Dr. Sullivan in 1995, tend to magnify and ruminate over their symptoms while feeling helpless about addressing them. “These individuals have an excessively alarmist attitude towards their pain and seem to have a lot more difficulty dealing with it,” he said at the meeting.

In the office setting, chronic pain patients who catastrophize “display more pain behavior such as holding, rubbing, guarding, as well as vocalizations such as moans and sighs,” he said at the meeting, which was sponsored by the International Association for the Study of Pain.

“Research shows that not only are catastrophizers going to have more difficulty in pain situations, they are also going to respond less well to the interventions that we offer them,” he said. In studies, Dr. Sullivan and his colleagues have shown that, compared with non-catastrophizers, catastrophizers are at greater risk of chronic pain following knee arthroplasty (Pain Res. Manag. 2008;13:335–41) and have more difficulty returning to work after whiplash injuries (J. Occup. Rehabil. 2007;17:305–15).

For patients whose chronic pain stems from an accident, perceptions of injustice also are common and can be expressed as anger or noncompliance. “Some of our recent research [Pain 2009;145:325–31] shows that perceptions of injustice are often associated with prolonged disability following a pain-related injury,” he said. For the treating physician, “validation techniques can be useful in reducing the negative impact of the catastrophizing patient's perceptions of injustice.”

By identifying catastrophizers early, physicians can avoid pitfalls that contribute to treatment failure in chronic pain. “There are some very concrete ways in which physicians could be reacting differently with these patients” to make patient management easier, he pointed out.

First and foremost, catastrophizers need to express their suffering and anxiety. “This person does have a story to tell and they need someone to listen. By not listening properly to that story initially, you are going to hear it again every time the patient comes, because the patient is going to feel that the doctor doesn't understand. So, increasing the time you initially spend with the patient can save a lot of headaches further down the line,” Dr. Sullivan explained.

Active listening has even been shown to reduce a patient's perception of pain, at least in the context of acute symptoms, said Dr. Sullivan, who has published several studies showing that allowing catastrophizers to disclose their fear and worry prior to routine dental hygiene procedures can reduce their perception of pain by as much as 50% (J. Indiana Dent. Assoc. 2000–2001;79:16–9; and Pain 1999;79:155–63).

Although a patient's basic personality is a challenge for physicians to work around, attitude – which is also an extremely powerful modifier of pain – is somewhat easier to mold, suggested Stefaan Van Damme, Ph.D., of the department of experimental clinical health and psychology at Ghent (Belgium) University.

In approaching pain control as a goal, chronic pain patients fall into two distinct categories: those who try to overcome it (assimilators) and those who accept it (accommodators). Both attitudes can be helpful or harmful, depending on how realistic pain control is for a particular patient, he said at the meeting.

“When pain is controllable, assimilative coping works. But when it is not controllable it can be maladaptive because it can exacerbate catastrophizing, hypervigilance, and distress,” he said. In a study, he demonstrated that, when attempts to avoid pain are unsuccessful, “individuals persist in their avoidance attempts, try harder, and narrow their focus of attention upon the problem to be solved” (Pain 2008;137:631–9).

Helping patients shift their focus from fighting to accepting their pain is particularly tricky for physicians, commented Dr. Sullivan, who is a psychologist. “I only get sent the patients when their pain has been long-standing. The concept of acceptance works when the pain has been there for 5 years,” he explained, “but for new-onset pain, acceptance is not the message that should be given by the doctor. This should only come up after we've offered everything else we can offer.”

Physicians should also be aware of their own personal psychology when dealing with catastrophizing patients, because catastrophizing personalities are not confined to the patient world. Physicians who are catastrophizers may inadvertently increase a patient's perception of suffering. “Some of our research suggests that if you're a catastrophizer you see 30% more pain in these individuals,” he said.

The speakers did not declare any conflicts of interest.

Major Finding: Seven markers of RA severity and six markers of cardiovascular risk were important and independent predictors of MI, stroke, or TIA during 2 years of follow-up in patients with RA.

Data Source: Post hoc analysis of data on 10,156 patients with RA enrolled in CORRONA, a longitudinal cohort study involving 103 U.S. medical centers.

Disclosures: There was no specific support for this analysis. CORRONA has received general support in the last 2 years from Abbott, Amgen, BMS, Centocor, Genentech, Lilly, and Roche. Dr. Solomon receives support from the National Institutes of Health, the Agency for Healthcare Quality and Research, the Arthritis Foundation, Abbott, and Amgen.

Both markers of rheumatoid arthritis severity and traditional markers of cardiovascular risk are important and independent predictors of future CV events among patients who have RA, according to a report published in the Annals of the Rheumatic Diseases.

Clinicians therefore can target both types of markers to reduce the incidence of CV events, which are the major source of mortality in patients with RA, said Dr. Daniel H. Solomon, chief of the section of clinical sciences in the division of rheumatology, immunology, and allergy at the Brigham and Women's Hospital, Boston, and his associates.

The investigators examined the relative importance of the two types of markers in predicting CV events using a large, longitudinal cohort of RA patients: subjects enrolled in CORRONA (Consortium of Rheumatology Researchers of North America), which includes more than 17,000 patients treated by 268 academic and community rheumatologists at 103 medical centers across the United States. Enrollment began in 2002, and patients were followed through 2006.

For this analysis, 10,156 subjects were followed for a median of 22 months for the development of incident MI, stroke, or transient ischemic attack. Cases of heart failure, peripheral artery disease, and CV-related death were excluded from the study. The subjects' mean age was 59 years, and 75% were women. Median disease duration at baseline was 7 years.

There were 29 MIs and 47 strokes or TIAs during follow-up, for an event rate of about 4 per 1,000 person-years.

Six traditional markers of CV risk – hypertension, diabetes, hyperlipidemia, current tobacco use, known cardiovascular disease, and a family history of premature (at age 50 years or younger) CV events – were important predictors of CV events during follow-up. In addition, seven markers of RA severity – disease duration greater than 5 years, radiographically evident joint erosions, subcutaneous nodules, prior total joint replacement, a score of 2 or more on the modified Health Assessment Questionnaire, a score of 23 or more on the Clinical Disease Activity Index, and seropositivity for rheumatoid factor – were strong, independent predictors of CV risk.

Moreover, the incidence of CV events escalated as the number of either type of risk factor increased. The incidence was 0 among patients with no CV risk factors and no markers of RA severity, and it rose to 7.5 per 1,000 person-years in patients with two or more CV risk factors and three or more markers of RA severity, Dr. Solomon and his colleagues said (Ann. Rheum. Dis. 2010;69:1920–5).

In statistical models that incorporated both types of risk factors plus patient age and sex, the predictive value was comparable to that calculated using the Framingham risk score, they noted.

“These results suggest that strategies to reduce CV risk should focus on a strategy of controlling both traditional CV risk factors as well as controlling RA severity,” the investigators said.

A large clinical trial statin use for primary prevention of CV events in RA patients is now under way, they added.

Major Finding: Seven markers of RA severity and six markers of cardiovascular risk were important and independent predictors of MI, stroke, or TIA during 2 years of follow-up in patients with RA.

Data Source: Post hoc analysis of data on 10,156 patients with RA enrolled in CORRONA, a longitudinal cohort study involving 103 U.S. medical centers.

Disclosures: There was no specific support for this analysis. CORRONA has received general support in the last 2 years from Abbott, Amgen, BMS, Centocor, Genentech, Lilly, and Roche. Dr. Solomon receives support from the National Institutes of Health, the Agency for Healthcare Quality and Research, the Arthritis Foundation, Abbott, and Amgen.

Both markers of rheumatoid arthritis severity and traditional markers of cardiovascular risk are important and independent predictors of future CV events among patients who have RA, according to a report published in the Annals of the Rheumatic Diseases.

Clinicians therefore can target both types of markers to reduce the incidence of CV events, which are the major source of mortality in patients with RA, said Dr. Daniel H. Solomon, chief of the section of clinical sciences in the division of rheumatology, immunology, and allergy at the Brigham and Women's Hospital, Boston, and his associates.

The investigators examined the relative importance of the two types of markers in predicting CV events using a large, longitudinal cohort of RA patients: subjects enrolled in CORRONA (Consortium of Rheumatology Researchers of North America), which includes more than 17,000 patients treated by 268 academic and community rheumatologists at 103 medical centers across the United States. Enrollment began in 2002, and patients were followed through 2006.

For this analysis, 10,156 subjects were followed for a median of 22 months for the development of incident MI, stroke, or transient ischemic attack. Cases of heart failure, peripheral artery disease, and CV-related death were excluded from the study. The subjects' mean age was 59 years, and 75% were women. Median disease duration at baseline was 7 years.

There were 29 MIs and 47 strokes or TIAs during follow-up, for an event rate of about 4 per 1,000 person-years.

Six traditional markers of CV risk – hypertension, diabetes, hyperlipidemia, current tobacco use, known cardiovascular disease, and a family history of premature (at age 50 years or younger) CV events – were important predictors of CV events during follow-up. In addition, seven markers of RA severity – disease duration greater than 5 years, radiographically evident joint erosions, subcutaneous nodules, prior total joint replacement, a score of 2 or more on the modified Health Assessment Questionnaire, a score of 23 or more on the Clinical Disease Activity Index, and seropositivity for rheumatoid factor – were strong, independent predictors of CV risk.

Moreover, the incidence of CV events escalated as the number of either type of risk factor increased. The incidence was 0 among patients with no CV risk factors and no markers of RA severity, and it rose to 7.5 per 1,000 person-years in patients with two or more CV risk factors and three or more markers of RA severity, Dr. Solomon and his colleagues said (Ann. Rheum. Dis. 2010;69:1920–5).

In statistical models that incorporated both types of risk factors plus patient age and sex, the predictive value was comparable to that calculated using the Framingham risk score, they noted.

“These results suggest that strategies to reduce CV risk should focus on a strategy of controlling both traditional CV risk factors as well as controlling RA severity,” the investigators said.

A large clinical trial statin use for primary prevention of CV events in RA patients is now under way, they added.

Major Finding: Seven markers of RA severity and six markers of cardiovascular risk were important and independent predictors of MI, stroke, or TIA during 2 years of follow-up in patients with RA.

Data Source: Post hoc analysis of data on 10,156 patients with RA enrolled in CORRONA, a longitudinal cohort study involving 103 U.S. medical centers.

Disclosures: There was no specific support for this analysis. CORRONA has received general support in the last 2 years from Abbott, Amgen, BMS, Centocor, Genentech, Lilly, and Roche. Dr. Solomon receives support from the National Institutes of Health, the Agency for Healthcare Quality and Research, the Arthritis Foundation, Abbott, and Amgen.

Both markers of rheumatoid arthritis severity and traditional markers of cardiovascular risk are important and independent predictors of future CV events among patients who have RA, according to a report published in the Annals of the Rheumatic Diseases.

Clinicians therefore can target both types of markers to reduce the incidence of CV events, which are the major source of mortality in patients with RA, said Dr. Daniel H. Solomon, chief of the section of clinical sciences in the division of rheumatology, immunology, and allergy at the Brigham and Women's Hospital, Boston, and his associates.

The investigators examined the relative importance of the two types of markers in predicting CV events using a large, longitudinal cohort of RA patients: subjects enrolled in CORRONA (Consortium of Rheumatology Researchers of North America), which includes more than 17,000 patients treated by 268 academic and community rheumatologists at 103 medical centers across the United States. Enrollment began in 2002, and patients were followed through 2006.

For this analysis, 10,156 subjects were followed for a median of 22 months for the development of incident MI, stroke, or transient ischemic attack. Cases of heart failure, peripheral artery disease, and CV-related death were excluded from the study. The subjects' mean age was 59 years, and 75% were women. Median disease duration at baseline was 7 years.

There were 29 MIs and 47 strokes or TIAs during follow-up, for an event rate of about 4 per 1,000 person-years.

Six traditional markers of CV risk – hypertension, diabetes, hyperlipidemia, current tobacco use, known cardiovascular disease, and a family history of premature (at age 50 years or younger) CV events – were important predictors of CV events during follow-up. In addition, seven markers of RA severity – disease duration greater than 5 years, radiographically evident joint erosions, subcutaneous nodules, prior total joint replacement, a score of 2 or more on the modified Health Assessment Questionnaire, a score of 23 or more on the Clinical Disease Activity Index, and seropositivity for rheumatoid factor – were strong, independent predictors of CV risk.

Moreover, the incidence of CV events escalated as the number of either type of risk factor increased. The incidence was 0 among patients with no CV risk factors and no markers of RA severity, and it rose to 7.5 per 1,000 person-years in patients with two or more CV risk factors and three or more markers of RA severity, Dr. Solomon and his colleagues said (Ann. Rheum. Dis. 2010;69:1920–5).

In statistical models that incorporated both types of risk factors plus patient age and sex, the predictive value was comparable to that calculated using the Framingham risk score, they noted.

“These results suggest that strategies to reduce CV risk should focus on a strategy of controlling both traditional CV risk factors as well as controlling RA severity,” the investigators said.

A large clinical trial statin use for primary prevention of CV events in RA patients is now under way, they added.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role – at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers.

Dr. Radboud Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and associates examined circulating cytokines in 134 pregnant patients with RA in their first trimester, 168 in their third trimester, and 33 healthy controls (J. Reprod. Immunol. [doi: 10.1016/j.jri.2010.08.010]).

Disease activity was based on the disease activity score for 28 joints (DAS28).

Among first trimester patients, 12 had detectable IL-10; all had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6).

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” they wrote. “In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester. This association was not present in the first trimester. This finding implies that “TNF blockers, which are more and more prescribed during pregnancy to treat [RA], should be used with caution,” they said.

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent conflicts.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role – at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers.

Dr. Radboud Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and associates examined circulating cytokines in 134 pregnant patients with RA in their first trimester, 168 in their third trimester, and 33 healthy controls (J. Reprod. Immunol. [doi: 10.1016/j.jri.2010.08.010]).

Disease activity was based on the disease activity score for 28 joints (DAS28).

Among first trimester patients, 12 had detectable IL-10; all had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6).

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” they wrote. “In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester. This association was not present in the first trimester. This finding implies that “TNF blockers, which are more and more prescribed during pregnancy to treat [RA], should be used with caution,” they said.

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent conflicts.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role – at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers.

Dr. Radboud Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and associates examined circulating cytokines in 134 pregnant patients with RA in their first trimester, 168 in their third trimester, and 33 healthy controls (J. Reprod. Immunol. [doi: 10.1016/j.jri.2010.08.010]).

Disease activity was based on the disease activity score for 28 joints (DAS28).

Among first trimester patients, 12 had detectable IL-10; all had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6).

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” they wrote. “In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester. This association was not present in the first trimester. This finding implies that “TNF blockers, which are more and more prescribed during pregnancy to treat [RA], should be used with caution,” they said.

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent conflicts.

Major Finding: During 12 years of follow-up, patients aged 65–75 years had a 13% revision rate following total hip replacement. Patients older than 75 years at the time of their initial hip replacement had a 9% rate of revision surgery during the same 12-year follow-up.

Data Source: Medicare records for 58,521 beneficiaries who had total hip replacement surgery during July 1995–June 1996 and who were followed through 2008.

Disclosures: Dr. Katz said that he had no disclosures.

BRUSSELS — When younger patients receive a total hip replacement, they are more likely to eventually need revision surgery, compared with older patients, according to findings from a 12-year follow-up study of more than 58,000 Medicare patients.

The finding makes sense and comes as no surprise, but the documentation of a link between younger age and increased revision rates has important implications for prosthesis design.

“As total hip replacement indications extend to increasingly younger populations, [the patients'] mortality risk will diminish, and a vast majority will remain at risk for revision for decades,” Dr. Jeffrey N. Katz said at the congress

“Research evaluating technical innovations to increase prosthesis longevity should recognize the competing risk of mortality. In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them. The older a patient is, the more likely the patient is to die with their original prosthesis intact,” said Dr. Katz, director of the orthopedic and arthritis center for outcomes research at Brigham and Women's Hospital, Boston.

“If a prosthesis manufacturer wants to increase the longevity of a prosthesis, the patients to target are those younger than 65. For patients who get through the perioperative period, the real issue is biomaterials: How likely are the biomaterials to wear out over time?” he noted.

Currently, about 280,000 total hip replacements are performed in the United States annually (more than 90% because of osteoarthritis), along with 40,000 revision hip surgeries each year. Revisions alone cost more than $1 billion annually.

Dr. Katz and his associates studied the 58,521 Medicare beneficiaries who underwent a total hip replacement during July 1995–June 1996. Two-thirds were women, and 60% were aged 65–75 years, with the remaining patients older than 75 years. The researchers had complete follow-up records for all patients for the subsequent 12 years, through 2008.

During follow-up, 60% of the patients who were older than 75 years at the time of surgery died; during the 12-year follow-up, the survivors had a revision rate of 9%. Among patients aged 65–75 years at the time of their initial hip surgery, 30% died during follow-up, with the survivors having a 13% revision rate. In both age groups, men had a higher revision rate than did women.

“Younger patients are more active and heavier,” Dr. Katz said in an interview at the congress, which was organized by the Osteoarthritis Research Society International.

“Younger patients probably wear [prosthetic] joints out faster, and – given the same amount of wear – they are offered [revision] surgery more frequently. … We don't have data for 45- to 65-year-olds, but by extension, their mortality is unlikely over the following 20 years, while a revision is likely,” Dr. Katz said.

'In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them.'

Source DR. KATZ

Major Finding: During 12 years of follow-up, patients aged 65–75 years had a 13% revision rate following total hip replacement. Patients older than 75 years at the time of their initial hip replacement had a 9% rate of revision surgery during the same 12-year follow-up.

Data Source: Medicare records for 58,521 beneficiaries who had total hip replacement surgery during July 1995–June 1996 and who were followed through 2008.

Disclosures: Dr. Katz said that he had no disclosures.

BRUSSELS — When younger patients receive a total hip replacement, they are more likely to eventually need revision surgery, compared with older patients, according to findings from a 12-year follow-up study of more than 58,000 Medicare patients.

The finding makes sense and comes as no surprise, but the documentation of a link between younger age and increased revision rates has important implications for prosthesis design.

“As total hip replacement indications extend to increasingly younger populations, [the patients'] mortality risk will diminish, and a vast majority will remain at risk for revision for decades,” Dr. Jeffrey N. Katz said at the congress

“Research evaluating technical innovations to increase prosthesis longevity should recognize the competing risk of mortality. In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them. The older a patient is, the more likely the patient is to die with their original prosthesis intact,” said Dr. Katz, director of the orthopedic and arthritis center for outcomes research at Brigham and Women's Hospital, Boston.

“If a prosthesis manufacturer wants to increase the longevity of a prosthesis, the patients to target are those younger than 65. For patients who get through the perioperative period, the real issue is biomaterials: How likely are the biomaterials to wear out over time?” he noted.

Currently, about 280,000 total hip replacements are performed in the United States annually (more than 90% because of osteoarthritis), along with 40,000 revision hip surgeries each year. Revisions alone cost more than $1 billion annually.

Dr. Katz and his associates studied the 58,521 Medicare beneficiaries who underwent a total hip replacement during July 1995–June 1996. Two-thirds were women, and 60% were aged 65–75 years, with the remaining patients older than 75 years. The researchers had complete follow-up records for all patients for the subsequent 12 years, through 2008.

During follow-up, 60% of the patients who were older than 75 years at the time of surgery died; during the 12-year follow-up, the survivors had a revision rate of 9%. Among patients aged 65–75 years at the time of their initial hip surgery, 30% died during follow-up, with the survivors having a 13% revision rate. In both age groups, men had a higher revision rate than did women.

“Younger patients are more active and heavier,” Dr. Katz said in an interview at the congress, which was organized by the Osteoarthritis Research Society International.

“Younger patients probably wear [prosthetic] joints out faster, and – given the same amount of wear – they are offered [revision] surgery more frequently. … We don't have data for 45- to 65-year-olds, but by extension, their mortality is unlikely over the following 20 years, while a revision is likely,” Dr. Katz said.

'In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them.'

Source DR. KATZ

Major Finding: During 12 years of follow-up, patients aged 65–75 years had a 13% revision rate following total hip replacement. Patients older than 75 years at the time of their initial hip replacement had a 9% rate of revision surgery during the same 12-year follow-up.

Data Source: Medicare records for 58,521 beneficiaries who had total hip replacement surgery during July 1995–June 1996 and who were followed through 2008.

Disclosures: Dr. Katz said that he had no disclosures.

BRUSSELS — When younger patients receive a total hip replacement, they are more likely to eventually need revision surgery, compared with older patients, according to findings from a 12-year follow-up study of more than 58,000 Medicare patients.

The finding makes sense and comes as no surprise, but the documentation of a link between younger age and increased revision rates has important implications for prosthesis design.

“As total hip replacement indications extend to increasingly younger populations, [the patients'] mortality risk will diminish, and a vast majority will remain at risk for revision for decades,” Dr. Jeffrey N. Katz said at the congress

“Research evaluating technical innovations to increase prosthesis longevity should recognize the competing risk of mortality. In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them. The older a patient is, the more likely the patient is to die with their original prosthesis intact,” said Dr. Katz, director of the orthopedic and arthritis center for outcomes research at Brigham and Women's Hospital, Boston.

“If a prosthesis manufacturer wants to increase the longevity of a prosthesis, the patients to target are those younger than 65. For patients who get through the perioperative period, the real issue is biomaterials: How likely are the biomaterials to wear out over time?” he noted.

Currently, about 280,000 total hip replacements are performed in the United States annually (more than 90% because of osteoarthritis), along with 40,000 revision hip surgeries each year. Revisions alone cost more than $1 billion annually.

Dr. Katz and his associates studied the 58,521 Medicare beneficiaries who underwent a total hip replacement during July 1995–June 1996. Two-thirds were women, and 60% were aged 65–75 years, with the remaining patients older than 75 years. The researchers had complete follow-up records for all patients for the subsequent 12 years, through 2008.

During follow-up, 60% of the patients who were older than 75 years at the time of surgery died; during the 12-year follow-up, the survivors had a revision rate of 9%. Among patients aged 65–75 years at the time of their initial hip surgery, 30% died during follow-up, with the survivors having a 13% revision rate. In both age groups, men had a higher revision rate than did women.

“Younger patients are more active and heavier,” Dr. Katz said in an interview at the congress, which was organized by the Osteoarthritis Research Society International.

“Younger patients probably wear [prosthetic] joints out faster, and – given the same amount of wear – they are offered [revision] surgery more frequently. … We don't have data for 45- to 65-year-olds, but by extension, their mortality is unlikely over the following 20 years, while a revision is likely,” Dr. Katz said.

'In a 75- or 80-year-old, revision is a rather infrequent event; their implant will likely outsurvive them.'

Source DR. KATZ

BRUSSELS — Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of low vitamin K levels in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” Dr. Tuhina Neogi said at the congress.

“The next step is an intervention trial,” said Dr. Neogi, a rheumatologist at Boston University. “Taken together, there is enough biological plausibility that vitamin K could play a role. … If [dietary supplementation] proves effective, it would be something easy for people to do for themselves.”

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis and associated pathology.

The investigators examined data that was collected from 1,180 people who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. They averaged 62 years of age; 62% were women, and their average body mass index was about 30 kg/m

The researchers made incidence osteoarthritis the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee osteoarthritis, those with vitamin K deficiency at baseline had a 43% increased risk, after adjustment for age, sex, BMI, bone mineral density, and vitamin D level at baseline. This increased risk just missed reaching statistical significance. Dr. Neogi suggested that this may have been a power issue, with too few vitamin K–deficient participants in the database.

An additional analysis that took into account the extent of knee osteoarthritis showed statistically significant links with vitamin K deficiency.

Those who developed osteoarthritis in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed osteoarthritis in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee osteoarthritis, she reported at the congress, which was organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing osteoarthritis. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant

Dr. Neogi said that she had no disclosures.

BRUSSELS — Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of low vitamin K levels in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” Dr. Tuhina Neogi said at the congress.

“The next step is an intervention trial,” said Dr. Neogi, a rheumatologist at Boston University. “Taken together, there is enough biological plausibility that vitamin K could play a role. … If [dietary supplementation] proves effective, it would be something easy for people to do for themselves.”

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis and associated pathology.

The investigators examined data that was collected from 1,180 people who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. They averaged 62 years of age; 62% were women, and their average body mass index was about 30 kg/m

The researchers made incidence osteoarthritis the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee osteoarthritis, those with vitamin K deficiency at baseline had a 43% increased risk, after adjustment for age, sex, BMI, bone mineral density, and vitamin D level at baseline. This increased risk just missed reaching statistical significance. Dr. Neogi suggested that this may have been a power issue, with too few vitamin K–deficient participants in the database.

An additional analysis that took into account the extent of knee osteoarthritis showed statistically significant links with vitamin K deficiency.

Those who developed osteoarthritis in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed osteoarthritis in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee osteoarthritis, she reported at the congress, which was organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing osteoarthritis. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant

Dr. Neogi said that she had no disclosures.

BRUSSELS — Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of low vitamin K levels in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” Dr. Tuhina Neogi said at the congress.

“The next step is an intervention trial,” said Dr. Neogi, a rheumatologist at Boston University. “Taken together, there is enough biological plausibility that vitamin K could play a role. … If [dietary supplementation] proves effective, it would be something easy for people to do for themselves.”

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis and associated pathology.

The investigators examined data that was collected from 1,180 people who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. They averaged 62 years of age; 62% were women, and their average body mass index was about 30 kg/m

The researchers made incidence osteoarthritis the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee osteoarthritis, those with vitamin K deficiency at baseline had a 43% increased risk, after adjustment for age, sex, BMI, bone mineral density, and vitamin D level at baseline. This increased risk just missed reaching statistical significance. Dr. Neogi suggested that this may have been a power issue, with too few vitamin K–deficient participants in the database.

An additional analysis that took into account the extent of knee osteoarthritis showed statistically significant links with vitamin K deficiency.

Those who developed osteoarthritis in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed osteoarthritis in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee osteoarthritis, she reported at the congress, which was organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing osteoarthritis. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant

Dr. Neogi said that she had no disclosures.

Major Finding: Bone trabecular integrity, assessed by fractal signature analysis of plain radiographs, correctly predicted about 85% of the joint space change in patients with knee OA.

Data Source: Review of radiographs taken from 60 patients with OA and 67 controls at baseline and at 12 and 24 months' follow-up.

Disclosures: Dr. Kraus said that she had no relevant disclosures. One coauthor is an employee of Optasia Medical; Optasia provided the software used for the radiograph analyses. Another coauthor is an employee of Pfizer; Pfizer supplied the database used in the study.

BRUSSELS — Analysis of plain x-ray images of knee joints from 60 patients with osteoarthritis confirmed that a novel method for assessing bone trabecular structure adjacent to knee joints provides a reliable prediction of future disease progression.

Assessment of bone trabecular integrity by fractal signature analysis “provides an osteoarthritis imaging biomarker that is a prognostic marker of knee osteoarthritis progression,” Dr. Virginia Byers Kraus said at the congress.

Baseline bone trabecular integrity predicted roughly 85% of the change in joint space area during 2 years of follow-up in patients with osteoarthritis (OA). The new study, which used x-rays from 60 patients with OA and 67 controls, is the second report to document the prognostic accuracy of fractal signature analysis of bone trabecular integrity in OA patients.

The first report, also from Dr. Kraus and her associates, came out last year, and involved 138 OA patients who were followed for 3 years (Arthritis Rheum. 2009;60:3711–22).

“The next step is to compare fractal signature analysis head to head with MRI and look at its ability to predict MRI changes” in OA patients, and “its ability to identify OA in the preradiographic stage,” she said in an interview.

Fractal signature analysis of bone trabecular integrity using x-ray images “gives you the ability to more fully phenotype patients than we've been able to, and it is less costly than MRI,” said Dr. Kraus, a rheumatologist and professor of medicine at Duke University in Durham, N.C. “It's very promising for identifying patients at high risk for progression in [an intervention] trial, and possibly to screen patients in the clinic.”

Fractal signature analysis evaluates the complexity of detail of a two-dimensional image. Past studies have successfully used the method to assess osteoporosis and arthritis of the spine, hip, wrists, hands, and knees before and after surgery. Fractal signature analysis has the major advantage of not being very sensitive to image-acquisition quality.

Although fractal signature analysis involves a complex statistical analysis of x-ray image data of bone structure adjacent to a patient's knee joint, Dr. Kraus and her associates incorporated that analysis into “KneeAnalyzer” software developed by Optasia Medical, a British company. Now that the software exists, “it is easy to use. It's just a tool to get at bone trabecular integrity. I think it can easily be widely adopted,” she said.

The new study used data collected in a nontherapeutic methods trial sponsored by Pfizer Inc. The data set included 60 women with knee OA whose average age wa 58 years and whose average body mass index was 35.6 kg/m

The researchers assessed bone trabecular integrity using fractal signature analysis on radiographs taken at baseline and at 12 and 24 months. The baseline measurements in the vertical dimension of bone trabecular integrity predicted changes in joint space area at 12 and 24 months, and in joint space width at 24 months. Baseline measures in the horizontal dimension were not predictive. The predicted changes based on baseline bone trabecular integrity accounted for 85%–87% of the actual change in joint space area over 24 months, Dr. Kraus reported at the congress, which was organized by the Osteoarthritis Research Society International.

Major Finding: Bone trabecular integrity, assessed by fractal signature analysis of plain radiographs, correctly predicted about 85% of the joint space change in patients with knee OA.

Data Source: Review of radiographs taken from 60 patients with OA and 67 controls at baseline and at 12 and 24 months' follow-up.

Disclosures: Dr. Kraus said that she had no relevant disclosures. One coauthor is an employee of Optasia Medical; Optasia provided the software used for the radiograph analyses. Another coauthor is an employee of Pfizer; Pfizer supplied the database used in the study.

BRUSSELS — Analysis of plain x-ray images of knee joints from 60 patients with osteoarthritis confirmed that a novel method for assessing bone trabecular structure adjacent to knee joints provides a reliable prediction of future disease progression.

Assessment of bone trabecular integrity by fractal signature analysis “provides an osteoarthritis imaging biomarker that is a prognostic marker of knee osteoarthritis progression,” Dr. Virginia Byers Kraus said at the congress.

Baseline bone trabecular integrity predicted roughly 85% of the change in joint space area during 2 years of follow-up in patients with osteoarthritis (OA). The new study, which used x-rays from 60 patients with OA and 67 controls, is the second report to document the prognostic accuracy of fractal signature analysis of bone trabecular integrity in OA patients.

The first report, also from Dr. Kraus and her associates, came out last year, and involved 138 OA patients who were followed for 3 years (Arthritis Rheum. 2009;60:3711–22).

“The next step is to compare fractal signature analysis head to head with MRI and look at its ability to predict MRI changes” in OA patients, and “its ability to identify OA in the preradiographic stage,” she said in an interview.

Fractal signature analysis of bone trabecular integrity using x-ray images “gives you the ability to more fully phenotype patients than we've been able to, and it is less costly than MRI,” said Dr. Kraus, a rheumatologist and professor of medicine at Duke University in Durham, N.C. “It's very promising for identifying patients at high risk for progression in [an intervention] trial, and possibly to screen patients in the clinic.”

Fractal signature analysis evaluates the complexity of detail of a two-dimensional image. Past studies have successfully used the method to assess osteoporosis and arthritis of the spine, hip, wrists, hands, and knees before and after surgery. Fractal signature analysis has the major advantage of not being very sensitive to image-acquisition quality.

Although fractal signature analysis involves a complex statistical analysis of x-ray image data of bone structure adjacent to a patient's knee joint, Dr. Kraus and her associates incorporated that analysis into “KneeAnalyzer” software developed by Optasia Medical, a British company. Now that the software exists, “it is easy to use. It's just a tool to get at bone trabecular integrity. I think it can easily be widely adopted,” she said.

The new study used data collected in a nontherapeutic methods trial sponsored by Pfizer Inc. The data set included 60 women with knee OA whose average age wa 58 years and whose average body mass index was 35.6 kg/m

The researchers assessed bone trabecular integrity using fractal signature analysis on radiographs taken at baseline and at 12 and 24 months. The baseline measurements in the vertical dimension of bone trabecular integrity predicted changes in joint space area at 12 and 24 months, and in joint space width at 24 months. Baseline measures in the horizontal dimension were not predictive. The predicted changes based on baseline bone trabecular integrity accounted for 85%–87% of the actual change in joint space area over 24 months, Dr. Kraus reported at the congress, which was organized by the Osteoarthritis Research Society International.

Major Finding: Bone trabecular integrity, assessed by fractal signature analysis of plain radiographs, correctly predicted about 85% of the joint space change in patients with knee OA.

Data Source: Review of radiographs taken from 60 patients with OA and 67 controls at baseline and at 12 and 24 months' follow-up.

Disclosures: Dr. Kraus said that she had no relevant disclosures. One coauthor is an employee of Optasia Medical; Optasia provided the software used for the radiograph analyses. Another coauthor is an employee of Pfizer; Pfizer supplied the database used in the study.

BRUSSELS — Analysis of plain x-ray images of knee joints from 60 patients with osteoarthritis confirmed that a novel method for assessing bone trabecular structure adjacent to knee joints provides a reliable prediction of future disease progression.

Assessment of bone trabecular integrity by fractal signature analysis “provides an osteoarthritis imaging biomarker that is a prognostic marker of knee osteoarthritis progression,” Dr. Virginia Byers Kraus said at the congress.

Baseline bone trabecular integrity predicted roughly 85% of the change in joint space area during 2 years of follow-up in patients with osteoarthritis (OA). The new study, which used x-rays from 60 patients with OA and 67 controls, is the second report to document the prognostic accuracy of fractal signature analysis of bone trabecular integrity in OA patients.

The first report, also from Dr. Kraus and her associates, came out last year, and involved 138 OA patients who were followed for 3 years (Arthritis Rheum. 2009;60:3711–22).

“The next step is to compare fractal signature analysis head to head with MRI and look at its ability to predict MRI changes” in OA patients, and “its ability to identify OA in the preradiographic stage,” she said in an interview.

Fractal signature analysis of bone trabecular integrity using x-ray images “gives you the ability to more fully phenotype patients than we've been able to, and it is less costly than MRI,” said Dr. Kraus, a rheumatologist and professor of medicine at Duke University in Durham, N.C. “It's very promising for identifying patients at high risk for progression in [an intervention] trial, and possibly to screen patients in the clinic.”

Fractal signature analysis evaluates the complexity of detail of a two-dimensional image. Past studies have successfully used the method to assess osteoporosis and arthritis of the spine, hip, wrists, hands, and knees before and after surgery. Fractal signature analysis has the major advantage of not being very sensitive to image-acquisition quality.

Although fractal signature analysis involves a complex statistical analysis of x-ray image data of bone structure adjacent to a patient's knee joint, Dr. Kraus and her associates incorporated that analysis into “KneeAnalyzer” software developed by Optasia Medical, a British company. Now that the software exists, “it is easy to use. It's just a tool to get at bone trabecular integrity. I think it can easily be widely adopted,” she said.

The new study used data collected in a nontherapeutic methods trial sponsored by Pfizer Inc. The data set included 60 women with knee OA whose average age wa 58 years and whose average body mass index was 35.6 kg/m

The researchers assessed bone trabecular integrity using fractal signature analysis on radiographs taken at baseline and at 12 and 24 months. The baseline measurements in the vertical dimension of bone trabecular integrity predicted changes in joint space area at 12 and 24 months, and in joint space width at 24 months. Baseline measures in the horizontal dimension were not predictive. The predicted changes based on baseline bone trabecular integrity accounted for 85%–87% of the actual change in joint space area over 24 months, Dr. Kraus reported at the congress, which was organized by the Osteoarthritis Research Society International.

BRUSSELS — Statin therapy may exert yet another beneficial clinical effect – preventing development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was significantly linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for several baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no significant impact on the incidence or progression of hip OA.

The findings suggest that knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of Erasmus University, Rotterdam, the Netherlands, and the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

“Our idea is that metabolic alterations are more important for knee osteoarthritis than for hip osteoarthritis.”

For example, Dr. Clockaerts cited prior reports that cholesterol may have a damaging effect on cartilage, and it may increase the formation and activity of bone marrow lesions. “Cholesterol is probably not good for knee osteoarthritis,” he said. Synovial fluid contains cholesterol, and statin treatment would reduce the level.

An additional hypothesis is that vascular pathology may contribute to the OA disease process, and that the beneficial effects of statin treatment on atherosclerosis and vascular function may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

“The systemic and intra-articular anti-inflammatory effects of statins are the most plausible explanations for the effect,” Dr. Clockaerts said.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study.

The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale. They excluded study participants with a history of rheumatoid arthritis, gout, ankylosing spondylitis, or a leg fracture that was treated with a prosthesis.

Information on statin use came from computerized pharmacy records for the Rotterdam suburb where participants lived. The analysis considered to be a statin user anyone who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

They identified incident OA of the knee or hip in people with a baseline KL score of 0 or 1 that subsequently became 2 or greater.

They defined a case of OA progression to be a person with a baseline KL score of 1, 2, or 3 whose score later increased by at least 1 point. Average follow-up was 6 years.

The analysis showed that among 3,056 people who were evaluable for incident knee OA, statin users had a statistically significant, 57% reduced rate of knee OA, compared with nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density, said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee osteoarthritis among 1,412 people with a baseline KL score of 1–3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a statistically significant difference.

The analysis did not look at the impact of specific statin types.

A similar analysis showed no significant interaction of statin use and the incidence of new-onset or progressing hip OA in more than 4,000 people who were evaluable for one of these end points, according to Dr. Clockaerts.

Further studies should directly test a statin's effect in an animal model for OA, such as the STR/ort mouse, which also shows metabolic derangements, he said.

Dr. Clockaerts said that he had no disclosures.

Vitals

Source Elsevier Global Medical News

BRUSSELS — Statin therapy may exert yet another beneficial clinical effect – preventing development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was significantly linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for several baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no significant impact on the incidence or progression of hip OA.

The findings suggest that knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of Erasmus University, Rotterdam, the Netherlands, and the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

“Our idea is that metabolic alterations are more important for knee osteoarthritis than for hip osteoarthritis.”

For example, Dr. Clockaerts cited prior reports that cholesterol may have a damaging effect on cartilage, and it may increase the formation and activity of bone marrow lesions. “Cholesterol is probably not good for knee osteoarthritis,” he said. Synovial fluid contains cholesterol, and statin treatment would reduce the level.

An additional hypothesis is that vascular pathology may contribute to the OA disease process, and that the beneficial effects of statin treatment on atherosclerosis and vascular function may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

“The systemic and intra-articular anti-inflammatory effects of statins are the most plausible explanations for the effect,” Dr. Clockaerts said.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study.

The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale. They excluded study participants with a history of rheumatoid arthritis, gout, ankylosing spondylitis, or a leg fracture that was treated with a prosthesis.

Information on statin use came from computerized pharmacy records for the Rotterdam suburb where participants lived. The analysis considered to be a statin user anyone who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

They identified incident OA of the knee or hip in people with a baseline KL score of 0 or 1 that subsequently became 2 or greater.

They defined a case of OA progression to be a person with a baseline KL score of 1, 2, or 3 whose score later increased by at least 1 point. Average follow-up was 6 years.

The analysis showed that among 3,056 people who were evaluable for incident knee OA, statin users had a statistically significant, 57% reduced rate of knee OA, compared with nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density, said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee osteoarthritis among 1,412 people with a baseline KL score of 1–3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a statistically significant difference.

The analysis did not look at the impact of specific statin types.

A similar analysis showed no significant interaction of statin use and the incidence of new-onset or progressing hip OA in more than 4,000 people who were evaluable for one of these end points, according to Dr. Clockaerts.

Further studies should directly test a statin's effect in an animal model for OA, such as the STR/ort mouse, which also shows metabolic derangements, he said.

Dr. Clockaerts said that he had no disclosures.

Vitals

Source Elsevier Global Medical News

BRUSSELS — Statin therapy may exert yet another beneficial clinical effect – preventing development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was significantly linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for several baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no significant impact on the incidence or progression of hip OA.

The findings suggest that knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of Erasmus University, Rotterdam, the Netherlands, and the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

“Our idea is that metabolic alterations are more important for knee osteoarthritis than for hip osteoarthritis.”

For example, Dr. Clockaerts cited prior reports that cholesterol may have a damaging effect on cartilage, and it may increase the formation and activity of bone marrow lesions. “Cholesterol is probably not good for knee osteoarthritis,” he said. Synovial fluid contains cholesterol, and statin treatment would reduce the level.

An additional hypothesis is that vascular pathology may contribute to the OA disease process, and that the beneficial effects of statin treatment on atherosclerosis and vascular function may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

“The systemic and intra-articular anti-inflammatory effects of statins are the most plausible explanations for the effect,” Dr. Clockaerts said.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study.

The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale. They excluded study participants with a history of rheumatoid arthritis, gout, ankylosing spondylitis, or a leg fracture that was treated with a prosthesis.

Information on statin use came from computerized pharmacy records for the Rotterdam suburb where participants lived. The analysis considered to be a statin user anyone who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

They identified incident OA of the knee or hip in people with a baseline KL score of 0 or 1 that subsequently became 2 or greater.

They defined a case of OA progression to be a person with a baseline KL score of 1, 2, or 3 whose score later increased by at least 1 point. Average follow-up was 6 years.

The analysis showed that among 3,056 people who were evaluable for incident knee OA, statin users had a statistically significant, 57% reduced rate of knee OA, compared with nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density, said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee osteoarthritis among 1,412 people with a baseline KL score of 1–3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a statistically significant difference.

The analysis did not look at the impact of specific statin types.

A similar analysis showed no significant interaction of statin use and the incidence of new-onset or progressing hip OA in more than 4,000 people who were evaluable for one of these end points, according to Dr. Clockaerts.

Further studies should directly test a statin's effect in an animal model for OA, such as the STR/ort mouse, which also shows metabolic derangements, he said.

Dr. Clockaerts said that he had no disclosures.

Vitals

Source Elsevier Global Medical News

Major Finding: After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

Data Source: A prospective cohort study involving 187 patients from the DREAM registry.

Disclosures: The DREAM registry is funded by the Dutch affiliations of Wyeth Pharmaceuticals, Abbott Laboratories, Schering-Plough, Roche Pharmaceuticals, UCB Pharma, and Bristol-Myers Squibb.

Statins can inhibit the beneficial effects of rituximab on disease activity in rheumatoid arthritis patients, according to a study of 187 patients from the Dutch Rheumatoid Arthritis Monitoring registry.

After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

The difference was of borderline statistical significance after adjustment for age, sex, baseline DAS28 score, and rheumatoid factor positivity, Dr. E.E.A. Arts of Radboud University Nijmegen (the Netherlands) Medical Center and colleagues reported.

Compared with the RTX-only patients, those exposed to statins also had a shorter effective period following RTX treatment (median of 9 months vs. 7 months), and were more likely to experience a failure event (hazard ratio, 2.3), after adjustment for the same confounders, the investigators said (Ann. Rheum. Dis. 2010 Oct. 18 [doi:10.1136/ard.2010.136093]).

All of the patients who participated in the DREAM registry were included in the prospective cohort study, and all received 50 mg of prednisone with the first RTX infusion.

Patients in both the RTX plus statin and the RTX-only groups had similar DAS28 scores at baseline.

The statin group was older (mean age, 66 vs. 58 years) and included a greater proportion of men than the RTX-only group (48% vs. 20%), but the groups were otherwise similar in demographic characteristics.

Although the study had a small sample size, it was sufficiently powered and showed a clinically relevant difference in DAS28 score changes over the 6-month study period, noted the investigators, who added that lack of randomization was another limitation of little concern, because “confounding by indication is unlikely.”

More studies to replicate these findings and measure the magnitude of the effect are needed, they said.

“Significant interactions of statins with RTX in RA have not previously been shown.

“A critical review of common practice regarding concomitant use of statins in RTX-treated patients with RA is needed,” according to Dr. Arts and co-investigators.

Major Finding: After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

Data Source: A prospective cohort study involving 187 patients from the DREAM registry.

Disclosures: The DREAM registry is funded by the Dutch affiliations of Wyeth Pharmaceuticals, Abbott Laboratories, Schering-Plough, Roche Pharmaceuticals, UCB Pharma, and Bristol-Myers Squibb.

Statins can inhibit the beneficial effects of rituximab on disease activity in rheumatoid arthritis patients, according to a study of 187 patients from the Dutch Rheumatoid Arthritis Monitoring registry.

After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

The difference was of borderline statistical significance after adjustment for age, sex, baseline DAS28 score, and rheumatoid factor positivity, Dr. E.E.A. Arts of Radboud University Nijmegen (the Netherlands) Medical Center and colleagues reported.

Compared with the RTX-only patients, those exposed to statins also had a shorter effective period following RTX treatment (median of 9 months vs. 7 months), and were more likely to experience a failure event (hazard ratio, 2.3), after adjustment for the same confounders, the investigators said (Ann. Rheum. Dis. 2010 Oct. 18 [doi:10.1136/ard.2010.136093]).

All of the patients who participated in the DREAM registry were included in the prospective cohort study, and all received 50 mg of prednisone with the first RTX infusion.

Patients in both the RTX plus statin and the RTX-only groups had similar DAS28 scores at baseline.

The statin group was older (mean age, 66 vs. 58 years) and included a greater proportion of men than the RTX-only group (48% vs. 20%), but the groups were otherwise similar in demographic characteristics.

Although the study had a small sample size, it was sufficiently powered and showed a clinically relevant difference in DAS28 score changes over the 6-month study period, noted the investigators, who added that lack of randomization was another limitation of little concern, because “confounding by indication is unlikely.”

More studies to replicate these findings and measure the magnitude of the effect are needed, they said.

“Significant interactions of statins with RTX in RA have not previously been shown.

“A critical review of common practice regarding concomitant use of statins in RTX-treated patients with RA is needed,” according to Dr. Arts and co-investigators.

Major Finding: After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

Data Source: A prospective cohort study involving 187 patients from the DREAM registry.

Disclosures: The DREAM registry is funded by the Dutch affiliations of Wyeth Pharmaceuticals, Abbott Laboratories, Schering-Plough, Roche Pharmaceuticals, UCB Pharma, and Bristol-Myers Squibb.

Statins can inhibit the beneficial effects of rituximab on disease activity in rheumatoid arthritis patients, according to a study of 187 patients from the Dutch Rheumatoid Arthritis Monitoring registry.

After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point).

The difference was of borderline statistical significance after adjustment for age, sex, baseline DAS28 score, and rheumatoid factor positivity, Dr. E.E.A. Arts of Radboud University Nijmegen (the Netherlands) Medical Center and colleagues reported.

Compared with the RTX-only patients, those exposed to statins also had a shorter effective period following RTX treatment (median of 9 months vs. 7 months), and were more likely to experience a failure event (hazard ratio, 2.3), after adjustment for the same confounders, the investigators said (Ann. Rheum. Dis. 2010 Oct. 18 [doi:10.1136/ard.2010.136093]).

All of the patients who participated in the DREAM registry were included in the prospective cohort study, and all received 50 mg of prednisone with the first RTX infusion.

Patients in both the RTX plus statin and the RTX-only groups had similar DAS28 scores at baseline.

The statin group was older (mean age, 66 vs. 58 years) and included a greater proportion of men than the RTX-only group (48% vs. 20%), but the groups were otherwise similar in demographic characteristics.

Although the study had a small sample size, it was sufficiently powered and showed a clinically relevant difference in DAS28 score changes over the 6-month study period, noted the investigators, who added that lack of randomization was another limitation of little concern, because “confounding by indication is unlikely.”

More studies to replicate these findings and measure the magnitude of the effect are needed, they said.

“Significant interactions of statins with RTX in RA have not previously been shown.

“A critical review of common practice regarding concomitant use of statins in RTX-treated patients with RA is needed,” according to Dr. Arts and co-investigators.

Major Finding: Compared with patients in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at 14 weeks' follow-up (−3.0 vs. 0.0 point change); the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change).

Data Source: A randomized, placebo-controlled study of 356 patients with ankylosing spondylitis.

Disclosures: This study was funded by Centocor Research and Development and the Schering-Plough Research Institute. Dr. Deodhar disclosed that he has received payments from, and served on the advisory board for Centocor. Other authors on the study disclosed receiving consultancy fees, speaking fees, and/or honoraria from numerous pharmaceutical companies.

The anti–tumor necrosis factor–alpha agent golimumab significantly reduced sleep disturbance and improved health-related quality of life in a randomized placebo-controlled trial of 356 patients with ankylosing spondylitis.

The investigators assessed sleep disturbance using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which asks patients how many times in the past month they have had trouble falling asleep, awakened several times per night, had trouble staying asleep (including waking far too early), and/or awakened after their usual amount of sleep feeling tired and worn out. On the scale, the possible answers for each question were 0 (not at all), 1 (1–3 days), 2 (4–7 days), 3 (8–14 days), 4 (15–21 days), and 5 (22–31 days). Thus, the total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance.

Study participants, who had moderate-to-severe sleep disturbance at baseline because of underlying pain associated with AS, were randomized to receive either placebo or treatment with 50 mg or 100 mg of golimumab subcutaneously every 4 weeks.

Most of the study participants were men. Their mean time since AS diagnosis was 11 years for the placebo group and 8 years for each golimumab group. The mean baseline JSEQ score was 10 for the placebo group, 10 for the 50-mg group, and 11 for the 100-mg group.

Compared with those in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at the 14-week follow-up (−3.0 vs. 0.0 point change), and the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change), Dr. Atul Deodhar, medical director of the rheumatology clinic at the Oregon Health & Science University, Portland, and colleagues reported.

The effect was similar with both the 50- and 100-mg golimumab dose, the investigators noted (Arthritis Care Res. 2010:62:1266–71).

The findings of this study − which is a secondary analysis of the previously reported GO-RAISE study that evaluated golimumab in AS patients – also showed that changes in the JSEQ scores during the course of the study significantly correlated with changes from baseline on Short Form–36 Health Survey summary scores, Bath AS Functional Index scores, Bath AS Disease Activity Index, inflammation assessments, and total and night back-pain scores.

Improvements in the night back-pain scores were the strongest predictor of improvement in sleep disturbance as measured by JSEQ scores.

Golimumab (Simponi) has Food and Drug Administration approval for treatment – with methotrexate – of moderately to severely active rheumatoid arthritis in adults; in the treatment of active psoriatic arthritis, in which it can be given with or without methotrexate; and in the treatment of active ankylosing spondylitis.

Major Finding: Compared with patients in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at 14 weeks' follow-up (−3.0 vs. 0.0 point change); the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change).

Data Source: A randomized, placebo-controlled study of 356 patients with ankylosing spondylitis.

Disclosures: This study was funded by Centocor Research and Development and the Schering-Plough Research Institute. Dr. Deodhar disclosed that he has received payments from, and served on the advisory board for Centocor. Other authors on the study disclosed receiving consultancy fees, speaking fees, and/or honoraria from numerous pharmaceutical companies.

The anti–tumor necrosis factor–alpha agent golimumab significantly reduced sleep disturbance and improved health-related quality of life in a randomized placebo-controlled trial of 356 patients with ankylosing spondylitis.

The investigators assessed sleep disturbance using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which asks patients how many times in the past month they have had trouble falling asleep, awakened several times per night, had trouble staying asleep (including waking far too early), and/or awakened after their usual amount of sleep feeling tired and worn out. On the scale, the possible answers for each question were 0 (not at all), 1 (1–3 days), 2 (4–7 days), 3 (8–14 days), 4 (15–21 days), and 5 (22–31 days). Thus, the total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance.

Study participants, who had moderate-to-severe sleep disturbance at baseline because of underlying pain associated with AS, were randomized to receive either placebo or treatment with 50 mg or 100 mg of golimumab subcutaneously every 4 weeks.

Most of the study participants were men. Their mean time since AS diagnosis was 11 years for the placebo group and 8 years for each golimumab group. The mean baseline JSEQ score was 10 for the placebo group, 10 for the 50-mg group, and 11 for the 100-mg group.

Compared with those in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at the 14-week follow-up (−3.0 vs. 0.0 point change), and the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change), Dr. Atul Deodhar, medical director of the rheumatology clinic at the Oregon Health & Science University, Portland, and colleagues reported.

The effect was similar with both the 50- and 100-mg golimumab dose, the investigators noted (Arthritis Care Res. 2010:62:1266–71).

The findings of this study − which is a secondary analysis of the previously reported GO-RAISE study that evaluated golimumab in AS patients – also showed that changes in the JSEQ scores during the course of the study significantly correlated with changes from baseline on Short Form–36 Health Survey summary scores, Bath AS Functional Index scores, Bath AS Disease Activity Index, inflammation assessments, and total and night back-pain scores.

Improvements in the night back-pain scores were the strongest predictor of improvement in sleep disturbance as measured by JSEQ scores.

Golimumab (Simponi) has Food and Drug Administration approval for treatment – with methotrexate – of moderately to severely active rheumatoid arthritis in adults; in the treatment of active psoriatic arthritis, in which it can be given with or without methotrexate; and in the treatment of active ankylosing spondylitis.

Major Finding: Compared with patients in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at 14 weeks' follow-up (−3.0 vs. 0.0 point change); the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change).

Data Source: A randomized, placebo-controlled study of 356 patients with ankylosing spondylitis.

Disclosures: This study was funded by Centocor Research and Development and the Schering-Plough Research Institute. Dr. Deodhar disclosed that he has received payments from, and served on the advisory board for Centocor. Other authors on the study disclosed receiving consultancy fees, speaking fees, and/or honoraria from numerous pharmaceutical companies.

The anti–tumor necrosis factor–alpha agent golimumab significantly reduced sleep disturbance and improved health-related quality of life in a randomized placebo-controlled trial of 356 patients with ankylosing spondylitis.

The investigators assessed sleep disturbance using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which asks patients how many times in the past month they have had trouble falling asleep, awakened several times per night, had trouble staying asleep (including waking far too early), and/or awakened after their usual amount of sleep feeling tired and worn out. On the scale, the possible answers for each question were 0 (not at all), 1 (1–3 days), 2 (4–7 days), 3 (8–14 days), 4 (15–21 days), and 5 (22–31 days). Thus, the total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance.

Study participants, who had moderate-to-severe sleep disturbance at baseline because of underlying pain associated with AS, were randomized to receive either placebo or treatment with 50 mg or 100 mg of golimumab subcutaneously every 4 weeks.

Most of the study participants were men. Their mean time since AS diagnosis was 11 years for the placebo group and 8 years for each golimumab group. The mean baseline JSEQ score was 10 for the placebo group, 10 for the 50-mg group, and 11 for the 100-mg group.

Compared with those in the placebo group, those in the golimumab groups had significantly greater median improvement from baseline on the 0- to 20-point JSEQ at the 14-week follow-up (−3.0 vs. 0.0 point change), and the improvement was sustained at 24-week follow-up (−3.0 vs. −1.0 point change), Dr. Atul Deodhar, medical director of the rheumatology clinic at the Oregon Health & Science University, Portland, and colleagues reported.

The effect was similar with both the 50- and 100-mg golimumab dose, the investigators noted (Arthritis Care Res. 2010:62:1266–71).

The findings of this study − which is a secondary analysis of the previously reported GO-RAISE study that evaluated golimumab in AS patients – also showed that changes in the JSEQ scores during the course of the study significantly correlated with changes from baseline on Short Form–36 Health Survey summary scores, Bath AS Functional Index scores, Bath AS Disease Activity Index, inflammation assessments, and total and night back-pain scores.

Improvements in the night back-pain scores were the strongest predictor of improvement in sleep disturbance as measured by JSEQ scores.

Golimumab (Simponi) has Food and Drug Administration approval for treatment – with methotrexate – of moderately to severely active rheumatoid arthritis in adults; in the treatment of active psoriatic arthritis, in which it can be given with or without methotrexate; and in the treatment of active ankylosing spondylitis.