Rheumatoid Arthritis

NEW YORK – Imaging seems to be the sine qua non of determining cardiovascular disease risk in patients with rheumatoid arthritis.

Dr. Jeffrey D. Greenberg noted that, over the last 10-15 years, epidemiologic studies have shown patients with rheumatoid arthritis (RA) have a twofold increase in the risk of myocardial infarction and stroke and an increase in cardiovascular-related deaths. "An important issue we face is how can we risk stratify our patients to predict who will develop cardiovascular disease? Imaging is a promising area that may help us develop biomarkers of risk or better understand pathophysiological mechanisms of RA."

The need for precise tools with which to predict risk has become more urgent with the recently published findings that carotid ultrasound measurement of carotid intima-media thickness has been found to predict coronary events in patients with RA, independent of traditional cardiovascular risk factors and manifestations of RA.

The study, conducted by Dr. Matthew R. Evans and his associates at Brooke Army Medical Center, Fort Sam Houston, Tex., found that there appears to be a dose-dependent relationship between plaque and risk, with a 2.5-fold increase with unilateral plaque and 4.3-fold increase with bilateral carotid plaque, suggesting that atherosclerosis plays a significant role in acute coronary events in patients with RA (Arthritis Rheum. 2011 [doi:10.1002/art.30265]).

In discussing Dr. Evans’s research at his presentation at a rheumatology meeting sponsored by New York University, Dr. Greenberg said that this is the first study to demonstrate the predictive value of measuring carotid intima-media thickness and plaque for cardiovascular events in RA patients.

In the Evans study, carotid ultrasounds were performed on 636 RA patients as part of the prospective ORALE (Outcome of Rheumatoid Arthritis Longitudinal Evaluation) study. These patients were followed for 3,402 person-years and, during that time, 84 patients experienced 121 new or recurrent acute coronary syndrome (ACS) events, such as myocardial infarction, unstable angina, cardiac arrest, or death from ischemic heart disease. The rate of ACS events was 3.5/100 patient-years for this group. If only those without a prior history of ACS were analyzed, this group had 66 ACS events, with an incidence of 2.1 ACS/100 person-years.

Multivariate analysis of baseline factors associated with incident or recurrent acute coronary syndromes revealed that two markers of atherosclerosis were independent predictors of a subsequent coronary event. Having a past cardiovascular event raised the risk almost threefold (hazard ratio, 2.87 [1.75, 4.73]; P = .001) and carotid intima-media thickness also raised the risk significantly (HR, 1.61 [1.24, 2.08]; P = .001). After substituting carotid plaque for intima-media thickness, the investigators found a 2.5-fold increase in risk for unilateral plaque and almost a sixfold increase in risk for bilateral plaque.

The findings confirmed that traditional demographic and cardiovascular risk factors also predict coronary events as would be expected. These include male gender (HR, 1.94 [1.11, 3.39]; P =.05), diabetes (HR, 2.24 [1.44, 3.50]; P = .001), and hypertension (HR=1.56 [1.00, 2.44]; P =.05). Measures of RA severity, such as swollen joint counts (HR, 1.03 [1.01, 1.06]; P = .01) and cumulative prednisone dose of 20 g (HR, 2.12, [1.32, 3.42]; P = .01), also had predictive value.

Dr. Greenberg, who is director of the Arthritis Translational Registry and Biorepository at NYU Hospital for Joint Diseases, is involved in ongoing studies using advanced MRI and PET techniques to visualize and quantify some of key histologic features of plaque that are most likely to rupture, which he calls "vulnerable plaque." These histologic features include macrophage content, plaque neovascularization, a lipid-rich necrotic core, and a thin fibrous cap.

Dr. Greenberg receives consulting fees from Genentech Inc.

NEW YORK – Imaging seems to be the sine qua non of determining cardiovascular disease risk in patients with rheumatoid arthritis.

Dr. Jeffrey D. Greenberg noted that, over the last 10-15 years, epidemiologic studies have shown patients with rheumatoid arthritis (RA) have a twofold increase in the risk of myocardial infarction and stroke and an increase in cardiovascular-related deaths. "An important issue we face is how can we risk stratify our patients to predict who will develop cardiovascular disease? Imaging is a promising area that may help us develop biomarkers of risk or better understand pathophysiological mechanisms of RA."

The need for precise tools with which to predict risk has become more urgent with the recently published findings that carotid ultrasound measurement of carotid intima-media thickness has been found to predict coronary events in patients with RA, independent of traditional cardiovascular risk factors and manifestations of RA.

The study, conducted by Dr. Matthew R. Evans and his associates at Brooke Army Medical Center, Fort Sam Houston, Tex., found that there appears to be a dose-dependent relationship between plaque and risk, with a 2.5-fold increase with unilateral plaque and 4.3-fold increase with bilateral carotid plaque, suggesting that atherosclerosis plays a significant role in acute coronary events in patients with RA (Arthritis Rheum. 2011 [doi:10.1002/art.30265]).

In discussing Dr. Evans’s research at his presentation at a rheumatology meeting sponsored by New York University, Dr. Greenberg said that this is the first study to demonstrate the predictive value of measuring carotid intima-media thickness and plaque for cardiovascular events in RA patients.

In the Evans study, carotid ultrasounds were performed on 636 RA patients as part of the prospective ORALE (Outcome of Rheumatoid Arthritis Longitudinal Evaluation) study. These patients were followed for 3,402 person-years and, during that time, 84 patients experienced 121 new or recurrent acute coronary syndrome (ACS) events, such as myocardial infarction, unstable angina, cardiac arrest, or death from ischemic heart disease. The rate of ACS events was 3.5/100 patient-years for this group. If only those without a prior history of ACS were analyzed, this group had 66 ACS events, with an incidence of 2.1 ACS/100 person-years.

Multivariate analysis of baseline factors associated with incident or recurrent acute coronary syndromes revealed that two markers of atherosclerosis were independent predictors of a subsequent coronary event. Having a past cardiovascular event raised the risk almost threefold (hazard ratio, 2.87 [1.75, 4.73]; P = .001) and carotid intima-media thickness also raised the risk significantly (HR, 1.61 [1.24, 2.08]; P = .001). After substituting carotid plaque for intima-media thickness, the investigators found a 2.5-fold increase in risk for unilateral plaque and almost a sixfold increase in risk for bilateral plaque.

The findings confirmed that traditional demographic and cardiovascular risk factors also predict coronary events as would be expected. These include male gender (HR, 1.94 [1.11, 3.39]; P =.05), diabetes (HR, 2.24 [1.44, 3.50]; P = .001), and hypertension (HR=1.56 [1.00, 2.44]; P =.05). Measures of RA severity, such as swollen joint counts (HR, 1.03 [1.01, 1.06]; P = .01) and cumulative prednisone dose of 20 g (HR, 2.12, [1.32, 3.42]; P = .01), also had predictive value.

Dr. Greenberg, who is director of the Arthritis Translational Registry and Biorepository at NYU Hospital for Joint Diseases, is involved in ongoing studies using advanced MRI and PET techniques to visualize and quantify some of key histologic features of plaque that are most likely to rupture, which he calls "vulnerable plaque." These histologic features include macrophage content, plaque neovascularization, a lipid-rich necrotic core, and a thin fibrous cap.

Dr. Greenberg receives consulting fees from Genentech Inc.

NEW YORK – Imaging seems to be the sine qua non of determining cardiovascular disease risk in patients with rheumatoid arthritis.

Dr. Jeffrey D. Greenberg noted that, over the last 10-15 years, epidemiologic studies have shown patients with rheumatoid arthritis (RA) have a twofold increase in the risk of myocardial infarction and stroke and an increase in cardiovascular-related deaths. "An important issue we face is how can we risk stratify our patients to predict who will develop cardiovascular disease? Imaging is a promising area that may help us develop biomarkers of risk or better understand pathophysiological mechanisms of RA."

The need for precise tools with which to predict risk has become more urgent with the recently published findings that carotid ultrasound measurement of carotid intima-media thickness has been found to predict coronary events in patients with RA, independent of traditional cardiovascular risk factors and manifestations of RA.

The study, conducted by Dr. Matthew R. Evans and his associates at Brooke Army Medical Center, Fort Sam Houston, Tex., found that there appears to be a dose-dependent relationship between plaque and risk, with a 2.5-fold increase with unilateral plaque and 4.3-fold increase with bilateral carotid plaque, suggesting that atherosclerosis plays a significant role in acute coronary events in patients with RA (Arthritis Rheum. 2011 [doi:10.1002/art.30265]).

In discussing Dr. Evans’s research at his presentation at a rheumatology meeting sponsored by New York University, Dr. Greenberg said that this is the first study to demonstrate the predictive value of measuring carotid intima-media thickness and plaque for cardiovascular events in RA patients.

In the Evans study, carotid ultrasounds were performed on 636 RA patients as part of the prospective ORALE (Outcome of Rheumatoid Arthritis Longitudinal Evaluation) study. These patients were followed for 3,402 person-years and, during that time, 84 patients experienced 121 new or recurrent acute coronary syndrome (ACS) events, such as myocardial infarction, unstable angina, cardiac arrest, or death from ischemic heart disease. The rate of ACS events was 3.5/100 patient-years for this group. If only those without a prior history of ACS were analyzed, this group had 66 ACS events, with an incidence of 2.1 ACS/100 person-years.

Multivariate analysis of baseline factors associated with incident or recurrent acute coronary syndromes revealed that two markers of atherosclerosis were independent predictors of a subsequent coronary event. Having a past cardiovascular event raised the risk almost threefold (hazard ratio, 2.87 [1.75, 4.73]; P = .001) and carotid intima-media thickness also raised the risk significantly (HR, 1.61 [1.24, 2.08]; P = .001). After substituting carotid plaque for intima-media thickness, the investigators found a 2.5-fold increase in risk for unilateral plaque and almost a sixfold increase in risk for bilateral plaque.

The findings confirmed that traditional demographic and cardiovascular risk factors also predict coronary events as would be expected. These include male gender (HR, 1.94 [1.11, 3.39]; P =.05), diabetes (HR, 2.24 [1.44, 3.50]; P = .001), and hypertension (HR=1.56 [1.00, 2.44]; P =.05). Measures of RA severity, such as swollen joint counts (HR, 1.03 [1.01, 1.06]; P = .01) and cumulative prednisone dose of 20 g (HR, 2.12, [1.32, 3.42]; P = .01), also had predictive value.

Dr. Greenberg, who is director of the Arthritis Translational Registry and Biorepository at NYU Hospital for Joint Diseases, is involved in ongoing studies using advanced MRI and PET techniques to visualize and quantify some of key histologic features of plaque that are most likely to rupture, which he calls "vulnerable plaque." These histologic features include macrophage content, plaque neovascularization, a lipid-rich necrotic core, and a thin fibrous cap.

Dr. Greenberg receives consulting fees from Genentech Inc.

NEW YORK – Using ultrasound to guide the diagnosis and treatment of rheumatologic conditions has been the standard of care in Europe for several years, and now the practice is becoming more common in the United States, according to Dr. Jonathan Samuels.

In 2008, Dr. Samuels and his colleagues at New York University surveyed members of the American College of Rheumatology and rheumatology fellow trainees across the country. They found that although about 20% said they were currently using ultrasound, more than 75% said it should be a standard clinical tool in the specialty (Bull. NYU Hosp. Jt. Dis. 2010;68:292-8). This suggests a trend that more rheumatologists are using ultrasound than a decade ago, said Dr. Samuels.

Ultrasound is also being introduced into many U.S. fellowship programs and academic departments for both clinical and research purposes, he said, adding that physicians have an increasing number of opportunities to train in the best ways to use ultrasound for rheumatologic conditions. The ACR has launched its own series of courses on using ultrasound. Rheumatologists can also get online education and guidance through the USSONAR (Ultrasound School of North American Rheumatologists). For the last 2 years, this institution has conducted an annual competency exam.

Meanwhile, the issue of certification remains up in the air. The ACR Musculoskeletal Ultrasound Task Force has been working to determine if and how it should certify its members in the use of ultrasound. ACR officials are currently surveying their members on this issue, said Dr. Samuels, a rheumatologist at New York University.

Dr. Samuels said that office-based ultrasound offers a number of advantages: it's painless and does not induce claustrophobia or anxiety. There's also no need for patients to be still for long period of time and no radiation exposure.

Ultrasound is much less expensive than other imaging alternatives.

Ultrasound also allows physicians to evaluate multiple joints from a number of views in a single imaging session, he said.

There are a number of potential uses for ultrasound in rheumatology, such as in diagnosing and evaluating treatment for inflammatory arthritis, crystal disease, and osteoarthritis (OA).

In inflammatory arthritis, ultrasound can help with diagnosis and prognosis by detecting erosions, synovitis, effusions, tenosynovitis, enthesopathy, and productive changes such as nodules and tophi. Rheumatologists can also evaluate treatment response by rescanning after prolonged treatment, he said.

In rheumatoid arthritis, clinicians can easily use ultrasound to look for erosions, Dr. Samuels said, and it is more sensitive than conventional radiography (Arthritis. Rheum. 2000;43:2762-70).

Ultrasound can also identify and determine whether it is necessary to aspirate a joint effusion in patients with knee OA. It can also help to guide injections that might otherwise be contraindicated if they were to be done blindly in the office, such as hip injections.

Dr. Samuels reported that he had no financial conflicts of interest.

Ultrasound (left) shows cartilage wear in knee oseoarthritis. An ultrasound of a metacarpophalangeal joint (right), which was expected to show synovial effusion/synovitis, instead revealed a subcutaneous cyst and a normal MCP.

Source Courtesy Dr. Jonathan Samuels

NEW YORK – Using ultrasound to guide the diagnosis and treatment of rheumatologic conditions has been the standard of care in Europe for several years, and now the practice is becoming more common in the United States, according to Dr. Jonathan Samuels.

In 2008, Dr. Samuels and his colleagues at New York University surveyed members of the American College of Rheumatology and rheumatology fellow trainees across the country. They found that although about 20% said they were currently using ultrasound, more than 75% said it should be a standard clinical tool in the specialty (Bull. NYU Hosp. Jt. Dis. 2010;68:292-8). This suggests a trend that more rheumatologists are using ultrasound than a decade ago, said Dr. Samuels.

Ultrasound is also being introduced into many U.S. fellowship programs and academic departments for both clinical and research purposes, he said, adding that physicians have an increasing number of opportunities to train in the best ways to use ultrasound for rheumatologic conditions. The ACR has launched its own series of courses on using ultrasound. Rheumatologists can also get online education and guidance through the USSONAR (Ultrasound School of North American Rheumatologists). For the last 2 years, this institution has conducted an annual competency exam.

Meanwhile, the issue of certification remains up in the air. The ACR Musculoskeletal Ultrasound Task Force has been working to determine if and how it should certify its members in the use of ultrasound. ACR officials are currently surveying their members on this issue, said Dr. Samuels, a rheumatologist at New York University.

Dr. Samuels said that office-based ultrasound offers a number of advantages: it's painless and does not induce claustrophobia or anxiety. There's also no need for patients to be still for long period of time and no radiation exposure.

Ultrasound is much less expensive than other imaging alternatives.

Ultrasound also allows physicians to evaluate multiple joints from a number of views in a single imaging session, he said.

There are a number of potential uses for ultrasound in rheumatology, such as in diagnosing and evaluating treatment for inflammatory arthritis, crystal disease, and osteoarthritis (OA).

In inflammatory arthritis, ultrasound can help with diagnosis and prognosis by detecting erosions, synovitis, effusions, tenosynovitis, enthesopathy, and productive changes such as nodules and tophi. Rheumatologists can also evaluate treatment response by rescanning after prolonged treatment, he said.

In rheumatoid arthritis, clinicians can easily use ultrasound to look for erosions, Dr. Samuels said, and it is more sensitive than conventional radiography (Arthritis. Rheum. 2000;43:2762-70).

Ultrasound can also identify and determine whether it is necessary to aspirate a joint effusion in patients with knee OA. It can also help to guide injections that might otherwise be contraindicated if they were to be done blindly in the office, such as hip injections.

Dr. Samuels reported that he had no financial conflicts of interest.

Ultrasound (left) shows cartilage wear in knee oseoarthritis. An ultrasound of a metacarpophalangeal joint (right), which was expected to show synovial effusion/synovitis, instead revealed a subcutaneous cyst and a normal MCP.

Source Courtesy Dr. Jonathan Samuels

NEW YORK – Using ultrasound to guide the diagnosis and treatment of rheumatologic conditions has been the standard of care in Europe for several years, and now the practice is becoming more common in the United States, according to Dr. Jonathan Samuels.

In 2008, Dr. Samuels and his colleagues at New York University surveyed members of the American College of Rheumatology and rheumatology fellow trainees across the country. They found that although about 20% said they were currently using ultrasound, more than 75% said it should be a standard clinical tool in the specialty (Bull. NYU Hosp. Jt. Dis. 2010;68:292-8). This suggests a trend that more rheumatologists are using ultrasound than a decade ago, said Dr. Samuels.

Ultrasound is also being introduced into many U.S. fellowship programs and academic departments for both clinical and research purposes, he said, adding that physicians have an increasing number of opportunities to train in the best ways to use ultrasound for rheumatologic conditions. The ACR has launched its own series of courses on using ultrasound. Rheumatologists can also get online education and guidance through the USSONAR (Ultrasound School of North American Rheumatologists). For the last 2 years, this institution has conducted an annual competency exam.

Meanwhile, the issue of certification remains up in the air. The ACR Musculoskeletal Ultrasound Task Force has been working to determine if and how it should certify its members in the use of ultrasound. ACR officials are currently surveying their members on this issue, said Dr. Samuels, a rheumatologist at New York University.

Dr. Samuels said that office-based ultrasound offers a number of advantages: it's painless and does not induce claustrophobia or anxiety. There's also no need for patients to be still for long period of time and no radiation exposure.

Ultrasound is much less expensive than other imaging alternatives.

Ultrasound also allows physicians to evaluate multiple joints from a number of views in a single imaging session, he said.

There are a number of potential uses for ultrasound in rheumatology, such as in diagnosing and evaluating treatment for inflammatory arthritis, crystal disease, and osteoarthritis (OA).

In inflammatory arthritis, ultrasound can help with diagnosis and prognosis by detecting erosions, synovitis, effusions, tenosynovitis, enthesopathy, and productive changes such as nodules and tophi. Rheumatologists can also evaluate treatment response by rescanning after prolonged treatment, he said.

In rheumatoid arthritis, clinicians can easily use ultrasound to look for erosions, Dr. Samuels said, and it is more sensitive than conventional radiography (Arthritis. Rheum. 2000;43:2762-70).

Ultrasound can also identify and determine whether it is necessary to aspirate a joint effusion in patients with knee OA. It can also help to guide injections that might otherwise be contraindicated if they were to be done blindly in the office, such as hip injections.

Dr. Samuels reported that he had no financial conflicts of interest.

Ultrasound (left) shows cartilage wear in knee oseoarthritis. An ultrasound of a metacarpophalangeal joint (right), which was expected to show synovial effusion/synovitis, instead revealed a subcutaneous cyst and a normal MCP.

Source Courtesy Dr. Jonathan Samuels

NEW ORLEANS – Think of psoriasis as a systemic disease whose key extracutaneous sites of involvement include the joints, eyes, and perhaps the coronary arteries, although that remains controversial.

“Psoriasis is an inflammatory condition that flows far beyond the skin,” Dr. Brian F. Mandell stressed at the meeting.

Dr. Mandell, professor and chairman of the department of medicine at the Cleveland Clinic, offered a rheumatologist's perspective on a disease whose full range of expression extends well afield of daily dermatologic practice.

Psoriatic joint disease. Two forms of joint disease are of particular relevance to the psoriatic population. One is the increased incidence of gouty arthritis in patients with the skin disease.

“The challenge here is to distinguish between gout and what appears to be a totally typical flare of psoriatic monoarticular arthritis. As a dermatologist, what you should expect from a rheumatology colleague in that setting is for us to stick a needle in the joint and make that distinction, because otherwise there's no way that distinction can be made with certainty.

“Patients tend to be hyperuricemic when they have psoriasis, so you can't use a laboratory test to make the distinction,” Dr. Mandell explained.

The occurrence of psoriatic arthritis is, rather surprisingly, unrelated to the severity of the skin disease. Nor is psoriatic arthritis strongly associated with nail involvement. The most important patterns of psoriatic arthritis include spondylitis, enthesitis, and peripheral arthritides.

The hallmark of spondylitis is morning stiffness and pain lasting for several hours. That's the key distinguishing feature separating inflammatory from mechanical back pain – and it's a complaint that definitely warrants sending a psoriasis patient to a rheumatologist, in Dr. Mandell's view.

Enthesitis involves inflammation where tendons and ligaments join to the bone. Common manifestations in patients with psoriatic arthritis include hip pain or pain on the outside of the knee. The onset is often subtle. Successful treatment requires high-intensity anti-inflammatory therapy; enthesitis doesn't respond well to pain medications.

In contrast to the subtleties of psoriatic enthesitis, psoriatic peripheral arthritis is generally a dramatic condition marked by impressive fluid accumulation. In dactylitis, the entire digit, not just a joint, is swollen and strikingly painful; this is the sausage digit. And unlike rheumatoid arthritis, psoriatic dactylitis occurs asymmetrically.

“Rheumatoid arthritis just doesn't do this. There are very few 'nevers' in medicine. But I've never seen rheumatoid arthritis take the form of a true dactylitis. When you see it in the absence of skin disease, as a rheumatologist I'm actually going to undress the patient and go looking for skin disease,” Dr. Mandell said.

Like psoriatic enthesitis, psoriatic dactylitis responds very well to full-dose anti-inflammatory medication, he added.

Very few inflammatory arthritides target the distal interphalangeal joints. Psoriatic arthritis is far and away the most common one. This is an exceedingly destructive disease process over time, and it warrants very aggressive treatment. Methotrexate is “reasonably effective” for all forms of psoriatic arthritis except spondylitis, according to Dr. Mandell. Anti–tumor necrosis factor biologics are strikingly effective for all manifestations of psoriatic arthritis; often lower doses are required than for treatment of skin disease.

Psoriatic uveitis. This uncommon disease manifestation affects only about 2% of psoriasis patients, but it's often insidious in onset and can result in irreversible loss of vision.

Psoriasis-associated uveitis can be either anterior or posterior. The anterior uveitis tends to be painful and often produces a minimally red and irritated eye. In contrast, posterior uveitis is often essentially devoid of symptoms other than perhaps floaters or a bit of blurring. Psoriasis-associated uveitis is more like the uveitis associated with inflammatory bowel disease than the classic HLA-B27-associated form of uveitis. “Be wary of any eye complaints, and be very liberal in referring to ophthalmology for a slit-lamp exam,” he advised.

Coronary artery disease. There's no question that psoriasis patients have an increased prevalence of the metabolic syndrome. And epidemiologic studies also demonstrate that they are at increased risk for CAD and cardiovascular events. But whether psoriasis constitutes an independent risk factor for acute ischemic heart disease or the increased risk is due to the high prevalence of traditional coronary risk factors in psoriasis patients remains a topic of active debate in both the dermatologic and internal medicine literature.

“Whether psoriasis is directly causative or merely an association I don't think really matters,” Dr. Mandell asserted. “When you have a patient with psoriasis in front of you, you need to take advantage of a teaching moment. They're naked, they're glowing in the dark from their psoriasis, and this is an opportunity to let them know there probably is a cardiovascular risk and they should be seeing their primary care provider to make sure their modifiable cardiovascular risk factors like lipids, hypertension, and smoking have been addressed. In that way you've done your job the same way I'll do my job in similar settings when I see a patient with rheumatoid arthritis or psoriatic arthritis.”

Dr. Mandell said that he has no relevant financial interests.

Methotrexate is 'reasonably effective' for all forms of psoriatic arthritis with the exception of spondylitis.

Source DR. MANDELL

NEW ORLEANS – Think of psoriasis as a systemic disease whose key extracutaneous sites of involvement include the joints, eyes, and perhaps the coronary arteries, although that remains controversial.

“Psoriasis is an inflammatory condition that flows far beyond the skin,” Dr. Brian F. Mandell stressed at the meeting.

Dr. Mandell, professor and chairman of the department of medicine at the Cleveland Clinic, offered a rheumatologist's perspective on a disease whose full range of expression extends well afield of daily dermatologic practice.

Psoriatic joint disease. Two forms of joint disease are of particular relevance to the psoriatic population. One is the increased incidence of gouty arthritis in patients with the skin disease.

“The challenge here is to distinguish between gout and what appears to be a totally typical flare of psoriatic monoarticular arthritis. As a dermatologist, what you should expect from a rheumatology colleague in that setting is for us to stick a needle in the joint and make that distinction, because otherwise there's no way that distinction can be made with certainty.

“Patients tend to be hyperuricemic when they have psoriasis, so you can't use a laboratory test to make the distinction,” Dr. Mandell explained.

The occurrence of psoriatic arthritis is, rather surprisingly, unrelated to the severity of the skin disease. Nor is psoriatic arthritis strongly associated with nail involvement. The most important patterns of psoriatic arthritis include spondylitis, enthesitis, and peripheral arthritides.

The hallmark of spondylitis is morning stiffness and pain lasting for several hours. That's the key distinguishing feature separating inflammatory from mechanical back pain – and it's a complaint that definitely warrants sending a psoriasis patient to a rheumatologist, in Dr. Mandell's view.

Enthesitis involves inflammation where tendons and ligaments join to the bone. Common manifestations in patients with psoriatic arthritis include hip pain or pain on the outside of the knee. The onset is often subtle. Successful treatment requires high-intensity anti-inflammatory therapy; enthesitis doesn't respond well to pain medications.

In contrast to the subtleties of psoriatic enthesitis, psoriatic peripheral arthritis is generally a dramatic condition marked by impressive fluid accumulation. In dactylitis, the entire digit, not just a joint, is swollen and strikingly painful; this is the sausage digit. And unlike rheumatoid arthritis, psoriatic dactylitis occurs asymmetrically.

“Rheumatoid arthritis just doesn't do this. There are very few 'nevers' in medicine. But I've never seen rheumatoid arthritis take the form of a true dactylitis. When you see it in the absence of skin disease, as a rheumatologist I'm actually going to undress the patient and go looking for skin disease,” Dr. Mandell said.

Like psoriatic enthesitis, psoriatic dactylitis responds very well to full-dose anti-inflammatory medication, he added.

Very few inflammatory arthritides target the distal interphalangeal joints. Psoriatic arthritis is far and away the most common one. This is an exceedingly destructive disease process over time, and it warrants very aggressive treatment. Methotrexate is “reasonably effective” for all forms of psoriatic arthritis except spondylitis, according to Dr. Mandell. Anti–tumor necrosis factor biologics are strikingly effective for all manifestations of psoriatic arthritis; often lower doses are required than for treatment of skin disease.

Psoriatic uveitis. This uncommon disease manifestation affects only about 2% of psoriasis patients, but it's often insidious in onset and can result in irreversible loss of vision.

Psoriasis-associated uveitis can be either anterior or posterior. The anterior uveitis tends to be painful and often produces a minimally red and irritated eye. In contrast, posterior uveitis is often essentially devoid of symptoms other than perhaps floaters or a bit of blurring. Psoriasis-associated uveitis is more like the uveitis associated with inflammatory bowel disease than the classic HLA-B27-associated form of uveitis. “Be wary of any eye complaints, and be very liberal in referring to ophthalmology for a slit-lamp exam,” he advised.

Coronary artery disease. There's no question that psoriasis patients have an increased prevalence of the metabolic syndrome. And epidemiologic studies also demonstrate that they are at increased risk for CAD and cardiovascular events. But whether psoriasis constitutes an independent risk factor for acute ischemic heart disease or the increased risk is due to the high prevalence of traditional coronary risk factors in psoriasis patients remains a topic of active debate in both the dermatologic and internal medicine literature.

“Whether psoriasis is directly causative or merely an association I don't think really matters,” Dr. Mandell asserted. “When you have a patient with psoriasis in front of you, you need to take advantage of a teaching moment. They're naked, they're glowing in the dark from their psoriasis, and this is an opportunity to let them know there probably is a cardiovascular risk and they should be seeing their primary care provider to make sure their modifiable cardiovascular risk factors like lipids, hypertension, and smoking have been addressed. In that way you've done your job the same way I'll do my job in similar settings when I see a patient with rheumatoid arthritis or psoriatic arthritis.”

Dr. Mandell said that he has no relevant financial interests.

Methotrexate is 'reasonably effective' for all forms of psoriatic arthritis with the exception of spondylitis.

Source DR. MANDELL

NEW ORLEANS – Think of psoriasis as a systemic disease whose key extracutaneous sites of involvement include the joints, eyes, and perhaps the coronary arteries, although that remains controversial.

“Psoriasis is an inflammatory condition that flows far beyond the skin,” Dr. Brian F. Mandell stressed at the meeting.

Dr. Mandell, professor and chairman of the department of medicine at the Cleveland Clinic, offered a rheumatologist's perspective on a disease whose full range of expression extends well afield of daily dermatologic practice.

Psoriatic joint disease. Two forms of joint disease are of particular relevance to the psoriatic population. One is the increased incidence of gouty arthritis in patients with the skin disease.

“The challenge here is to distinguish between gout and what appears to be a totally typical flare of psoriatic monoarticular arthritis. As a dermatologist, what you should expect from a rheumatology colleague in that setting is for us to stick a needle in the joint and make that distinction, because otherwise there's no way that distinction can be made with certainty.

“Patients tend to be hyperuricemic when they have psoriasis, so you can't use a laboratory test to make the distinction,” Dr. Mandell explained.

The occurrence of psoriatic arthritis is, rather surprisingly, unrelated to the severity of the skin disease. Nor is psoriatic arthritis strongly associated with nail involvement. The most important patterns of psoriatic arthritis include spondylitis, enthesitis, and peripheral arthritides.

The hallmark of spondylitis is morning stiffness and pain lasting for several hours. That's the key distinguishing feature separating inflammatory from mechanical back pain – and it's a complaint that definitely warrants sending a psoriasis patient to a rheumatologist, in Dr. Mandell's view.

Enthesitis involves inflammation where tendons and ligaments join to the bone. Common manifestations in patients with psoriatic arthritis include hip pain or pain on the outside of the knee. The onset is often subtle. Successful treatment requires high-intensity anti-inflammatory therapy; enthesitis doesn't respond well to pain medications.

In contrast to the subtleties of psoriatic enthesitis, psoriatic peripheral arthritis is generally a dramatic condition marked by impressive fluid accumulation. In dactylitis, the entire digit, not just a joint, is swollen and strikingly painful; this is the sausage digit. And unlike rheumatoid arthritis, psoriatic dactylitis occurs asymmetrically.

“Rheumatoid arthritis just doesn't do this. There are very few 'nevers' in medicine. But I've never seen rheumatoid arthritis take the form of a true dactylitis. When you see it in the absence of skin disease, as a rheumatologist I'm actually going to undress the patient and go looking for skin disease,” Dr. Mandell said.

Like psoriatic enthesitis, psoriatic dactylitis responds very well to full-dose anti-inflammatory medication, he added.

Very few inflammatory arthritides target the distal interphalangeal joints. Psoriatic arthritis is far and away the most common one. This is an exceedingly destructive disease process over time, and it warrants very aggressive treatment. Methotrexate is “reasonably effective” for all forms of psoriatic arthritis except spondylitis, according to Dr. Mandell. Anti–tumor necrosis factor biologics are strikingly effective for all manifestations of psoriatic arthritis; often lower doses are required than for treatment of skin disease.

Psoriatic uveitis. This uncommon disease manifestation affects only about 2% of psoriasis patients, but it's often insidious in onset and can result in irreversible loss of vision.

Psoriasis-associated uveitis can be either anterior or posterior. The anterior uveitis tends to be painful and often produces a minimally red and irritated eye. In contrast, posterior uveitis is often essentially devoid of symptoms other than perhaps floaters or a bit of blurring. Psoriasis-associated uveitis is more like the uveitis associated with inflammatory bowel disease than the classic HLA-B27-associated form of uveitis. “Be wary of any eye complaints, and be very liberal in referring to ophthalmology for a slit-lamp exam,” he advised.

Coronary artery disease. There's no question that psoriasis patients have an increased prevalence of the metabolic syndrome. And epidemiologic studies also demonstrate that they are at increased risk for CAD and cardiovascular events. But whether psoriasis constitutes an independent risk factor for acute ischemic heart disease or the increased risk is due to the high prevalence of traditional coronary risk factors in psoriasis patients remains a topic of active debate in both the dermatologic and internal medicine literature.

“Whether psoriasis is directly causative or merely an association I don't think really matters,” Dr. Mandell asserted. “When you have a patient with psoriasis in front of you, you need to take advantage of a teaching moment. They're naked, they're glowing in the dark from their psoriasis, and this is an opportunity to let them know there probably is a cardiovascular risk and they should be seeing their primary care provider to make sure their modifiable cardiovascular risk factors like lipids, hypertension, and smoking have been addressed. In that way you've done your job the same way I'll do my job in similar settings when I see a patient with rheumatoid arthritis or psoriatic arthritis.”

Dr. Mandell said that he has no relevant financial interests.

Methotrexate is 'reasonably effective' for all forms of psoriatic arthritis with the exception of spondylitis.

Source DR. MANDELL

Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

Chondroitin sulfate slows the progression of knee osteoarthritis, according to findings from a pilot study that used magnetic resonance imaging to assess joint structural changes.

“It's reassuring to see that the four major x-ray studies are now confirmed by high technology in the assessment of disease progression,” said the study's lead author, Dr. Jean-Pierre Pelletier, in an interview (Osteoarthr. Cartil. 1998;6:39-46; Osteoarthr. Cartil. 2004;12:269-76; Arthritis Rheum. 2005;52:779-86; Arthritis Rheum. 2009;60:524-33).

The randomized, double-blind, placebo-controlled study showed that chondroitin sulfate reduced the cartilage loss volume in 69 patients with knee osteoarthritis in as early as 6 months. (Ann. Rheum. Dis. 2011 March 1).

The findings show that magnetic resonance imaging (MRI) “is a good quantitative technique to find answers in a shorter period of time with a smaller number of patients,” said Dr. Roy D. Altman, professor of medicine at the University of California, Los Angeles, who is not involved with the study.

The effect of the disease-modifying drug chondroitin sulfate on cartilage volume loss, bone marrow lesions (BML), and disease symptoms has been controversial (BMJ 2010;341:c4675). However, the authors of this study said that the MRI findings provided additional evidence regarding the joint structure protective effect of chondroitin sulfate.

Several studies have also shown that MRI can quantitatively and reliably assess the volume and cartilage thickness in addition to joint structural changes in subchondral bone, menisci, and synovium, according to the authors.

“MRI provides you with direct visualization of the cartilage,” said Dr. Pelletier, director of the osteoarthritis research unit at the University of Montreal Hospital Research Centre. “And the beauty of MRI is that it provides assessment of progression of change not only in cartilage, but also in many other tissues of the joint, like the subchondral bone and the synovium.

“In addition, the pronounced reduction in OA cartilage loss found in patients treated with chondroitin sulfate was also associated with a reduction in the size of BML. This finding is most interesting as BML are believed to be associated with the progression of OA cartilage lesions,” according to a number of studies, said Dr. Pelletier.

The study also showed that patients being treated with nonsteroidal anti-inflammatory drugs in addition to chondroitin sulfate showed a significant reduction in synovial membrane thickness (1.3 plus or minus 0.3 mm in 6 months vs. 1.6 plus or minus 0.3 mm with placebo), and a lower incidence of joint swelling, compared with the placebo group (0% in chondroitin sulfate vs. 11.4% in placebo). The finding “is interesting with practical clinical impact, and definitely needs future exploration,” the authors wrote.

Dr. Pelletier and his colleagues recruited 69 patients of both sexes between 40 and 80 years of age from rheumatology clinics in Quebec province. All patients had clinical signs of synovitis.

The study had two phases. For the double-blind phase, the patients were randomly assigned to once-daily placebo or 800 mg of chondroitin sulfate for 6 months. During the following 6 months, or the open-label phase, both study groups received 800 mg of chondroitin sulfate daily.

Cartilage volume and BML were assessed by MRI at baseline, 6 months, and 12 months. Synovial membrane thickness was assessed at baseline and 6 months.

Patients who took a daily oral dose of chondroitin sulfate had a significant reduction in cartilage volume loss at 6 months (–2.87%) and 12 months (–3.71%) in the global knee, compared with the placebo group (–4.67% at 6 months and –6.12% at 12 months).

There were no differences in BML during the first 6 months of the study. But at 12 months, reductions in BML were observed in the chondroitin sulfate group (–0.57%), especially in the lateral compartment (–0.13%) and the lateral condyle (–0.43). The additional 6 months needed to see the difference in BML between the groupsccould suggest that “BML are consequential to cartilage degradation and thus reducing cartilage lesions could lead to fewer BML. Alternatively, BML were shown to be involved in an inflammatory/catabolic process on which chondroitin sulfate could act directly, leading to structural repair,” according to the study authors.

No significant differences in disease symptoms were measured by visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires. “The main aim of the study was not the symptoms. The main goal was to find out whether chondroitin sulfate can reduce progression of knee OA,” said Dr. Pelletier.

The study had a number of limitations, including its small sample size. In addition, the system used did not allow the detection of the cartilage in the patella, the researchers reported. They added that long-term studies are needed to find the impact of chondroitin sulfate in disease symptoms.

Whether the quantitative MRI technique will eventually replace x-ray technology in such studies is unclear, said Dr. Pelletier. “That's for regulatory bodies to decide,” he said.

“But it's quite clear that MRI is the technology of the future. It's very helpful, because you can truly speed up drug development in the field of OA and with less expense, using a smaller number of patients and in a shorter period of time.”

Dr. Jean-Pierre Pelletier and Dr. Johanne Martel-Pelletier are consultants for and shareholders in ArthroLab and ArthroVision. Jean-Pierre Raynauld is a consultant for ArthroVision. Dr. André Beaulieu, Dr. Louis Bassette, and Dr. Frédéric Morin received honoraria from ArthroLab. François Abram is an employee of ArthroVision. Marc Dorais is a consultant for ArthroVision. Dr. Altman had no relevant financial conflicts of interest.

Major Finding: Patients with early rheumatoid arthritis rarely have radiographic progression within the first 2 years of the disease.

Data Source: Analysis of clinical indicators and radiographic progression in 529 patients from the SONORA observational early rheumatoid arthritis cohort.

Disclosures: Ms. Chen said she had no relevant financial disclosures.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto.

For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported.

Radiographic progression in the patients at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, and rheumatoid factor (RF) status, as well as smoking history.

Of these potential indicators, “baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period,” Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, according to Ms. Chen.

“Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline,” she said.

The findings of the study provide insight into the patterns and characteristics of radiographic damage in patients with early rheumatoid arthritis, “and they may also contribute to clinical decision making,” according to Ms. Chen.

The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Major Finding: Patients with early rheumatoid arthritis rarely have radiographic progression within the first 2 years of the disease.

Data Source: Analysis of clinical indicators and radiographic progression in 529 patients from the SONORA observational early rheumatoid arthritis cohort.

Disclosures: Ms. Chen said she had no relevant financial disclosures.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto.

For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported.

Radiographic progression in the patients at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, and rheumatoid factor (RF) status, as well as smoking history.

Of these potential indicators, “baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period,” Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, according to Ms. Chen.

“Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline,” she said.

The findings of the study provide insight into the patterns and characteristics of radiographic damage in patients with early rheumatoid arthritis, “and they may also contribute to clinical decision making,” according to Ms. Chen.

The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Major Finding: Patients with early rheumatoid arthritis rarely have radiographic progression within the first 2 years of the disease.

Data Source: Analysis of clinical indicators and radiographic progression in 529 patients from the SONORA observational early rheumatoid arthritis cohort.

Disclosures: Ms. Chen said she had no relevant financial disclosures.

CANCUN, MEXICO – Most patients with early rheumatoid arthritis do not have radiographic progression within the first 2 years of the disease, a study has shown.

Additionally, the risk of continuous radiographic progression during this period can be predicted using certain baseline indicators of disease activity, Maggie Hong Chen reported at the meeting.

An analysis of data from the Study of New-Onset Rheumatoid Arthritis (SONORA) cohort using the original Sharp method to score radiographic progression over 2 years identified the following four patterns among the 529 early arthritis patients included in the investigation: never progressed, progressed at year 1 only; progressed at year 2 only, and progressed at both year 1 and year 2, said Ms. Chen, a research fellow in the University Health Network Research Institute of the University of Toronto.

For the analysis, radiographic progression was defined as a change in total Sharp score of at least 3.5 within a year, she noted.

Of the 529 patients – all of whom were diagnosed with early rheumatoid arthritis based on symptom duration of 3-12 months and who had hand radiographs obtained at baseline, 1 year, and 2 years – 457 patients (86%) had no progression, Ms. Chen reported.

Radiographic progression in the patients at year 1, year 2, and both years 1 and 2 was observed in 18 patients (3.4%), 40 patients (7.6%), and 14 (2.6%), respectively, she said.

The investigators evaluated multiple potential clinical indicators of progression, including baseline Sharp score, baseline levels of C-reactive protein (CRP), answers to the Health Assessment Questionnaire (HAQ), swollen joint count, disease duration, anticyclic citrullinated peptide (anti-CCP) antibody status, gender, and rheumatoid factor (RF) status, as well as smoking history.

Of these potential indicators, “baseline Sharp score was a statistically significant indicator of whether the subject would progress within the 2-year period,” Ms. Chen stated, noting that, in the no-progression group, the mean baseline Sharp score was 4.06, compared with 9.33 in the 1-year progression group, 8.28 in the 2-year progression group, and 14.0 among the patients with progression both years.

Significant differences were also observed between the patterns for CRP score, baseline HAQ, swollen joint count, and anti-CCP positive status, according to Ms. Chen.

“Subjects who had no radiographic progression within the 2-year period were younger with a lower swollen joint count, a lower disease activity score [DAS], and lower CRP. They were also negative for anti-CCP and RF at baseline,” she said.

The findings of the study provide insight into the patterns and characteristics of radiographic damage in patients with early rheumatoid arthritis, “and they may also contribute to clinical decision making,” according to Ms. Chen.

The identified indicators can help rheumatologists identify patients at highest risk of continuous radiographic progression and manage them accordingly, potentially with more aggressive therapy if warranted, she said.

Major Finding: In the short term, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19), and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Data Source: A meta-analysis of data from 163 randomized controlled trials with 50,010 adult participants and 46 extension studies with 11,954 adult participants.

Disclosures: Dr. Singh and several of his coauthors reported that they have significant financial relationships with several pharmaceutical companies.

Biologics appear to be associated with a significantly greater rate of total adverse events, withdrawals due to adverse events, and an increased risk of tuberculosis reactivation compared with control agents, based on a meta-analysis involving more than 60,000 patients.

However, there were no significant differences in the rates of serious adverse events, serious infections, lymphoma, and congestive heart failure between biologics and control agents, wrote Dr. Jasvinder A. Singh and his coauthors (Cochrane Database Syst. Rev. 2011 [doi: 10.1002/14651858.CD008794.pub2]); http://www2.cochrane.org/reviews/en/ab008794.html

The results come from a network meta-analysis and Cochrane overview of the adverse effects of biologic drugs that are approved for the treatment of rheumatoid arthritis and other conditions in Europe, the United Kingdom, the United States, Canada, and Australia.

The investigators included randomized controlled trials (RCTs), controlled clinical trials, and open-label extension studies that involved one of the nine biologics for use in any indication and that reported this study's prespecified adverse outcomes. The researchers did not include studies on biologics for the treatment of HIV/AIDS. The nine biologics investigated were abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan/MabThera), and tocilizumab (Actemra). They searched the Cochrane Library, Medline, and Embase (through January 2010).

The investigators performed mixed-effects logistic regression using an arm-based, random-effects model within an empirical Bayes framework for the network meta-analysis.

In all, included in the analysis were 163 RCTs with 50,010 adult participants and 46 extension studies with 11,954 adult participants. The median duration was 6 months for the RCTs and 13 months for the extension studies. Given the short duration of the RCTs, all the results should be interpreted as applying to a fairly short time frame.

After the analysis was adjusted for dose, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19) and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Certolizumab pegol was associated with a significantly greater risk of serious infections than was control treatment (OR 3.51), according to the report. Infliximab was associated with a significantly greater risk of withdrawals due to adverse events compared with the control (OR 2.04).

Heart failure and cancer have been of particular concern with the use of biologic drugs.

There appears to be little or no difference in the number of people who experienced heart failure or cancer taking any biologic compared with people who took placebo. However, there were not many cases of congestive heart failure or cancer, so confidence in these results is low.

The researchers also were able to indirectly compare individual biologics.

These analyses revealed that abatacept and anakinra were associated with a significantly lower risk of serious adverse events than were most other biologics. In addition, certolizumab pegol was associated with significantly greater odds of serious infections than were etanercept, adalimumab, abatacept, anakinra, golimumab, infliximab, and rituximab. Abatacept was significantly less likely than infliximab and tocilizumab to be associated with serious infections; abatacept, adalimumab, etanercept, and golimumab were significantly less likely than infliximab to result in withdrawals due to adverse events.

“There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics,” they concluded.

Major Finding: In the short term, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19), and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Data Source: A meta-analysis of data from 163 randomized controlled trials with 50,010 adult participants and 46 extension studies with 11,954 adult participants.

Disclosures: Dr. Singh and several of his coauthors reported that they have significant financial relationships with several pharmaceutical companies.

Biologics appear to be associated with a significantly greater rate of total adverse events, withdrawals due to adverse events, and an increased risk of tuberculosis reactivation compared with control agents, based on a meta-analysis involving more than 60,000 patients.

However, there were no significant differences in the rates of serious adverse events, serious infections, lymphoma, and congestive heart failure between biologics and control agents, wrote Dr. Jasvinder A. Singh and his coauthors (Cochrane Database Syst. Rev. 2011 [doi: 10.1002/14651858.CD008794.pub2]); http://www2.cochrane.org/reviews/en/ab008794.html

The results come from a network meta-analysis and Cochrane overview of the adverse effects of biologic drugs that are approved for the treatment of rheumatoid arthritis and other conditions in Europe, the United Kingdom, the United States, Canada, and Australia.

The investigators included randomized controlled trials (RCTs), controlled clinical trials, and open-label extension studies that involved one of the nine biologics for use in any indication and that reported this study's prespecified adverse outcomes. The researchers did not include studies on biologics for the treatment of HIV/AIDS. The nine biologics investigated were abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan/MabThera), and tocilizumab (Actemra). They searched the Cochrane Library, Medline, and Embase (through January 2010).

The investigators performed mixed-effects logistic regression using an arm-based, random-effects model within an empirical Bayes framework for the network meta-analysis.

In all, included in the analysis were 163 RCTs with 50,010 adult participants and 46 extension studies with 11,954 adult participants. The median duration was 6 months for the RCTs and 13 months for the extension studies. Given the short duration of the RCTs, all the results should be interpreted as applying to a fairly short time frame.

After the analysis was adjusted for dose, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19) and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Certolizumab pegol was associated with a significantly greater risk of serious infections than was control treatment (OR 3.51), according to the report. Infliximab was associated with a significantly greater risk of withdrawals due to adverse events compared with the control (OR 2.04).

Heart failure and cancer have been of particular concern with the use of biologic drugs.

There appears to be little or no difference in the number of people who experienced heart failure or cancer taking any biologic compared with people who took placebo. However, there were not many cases of congestive heart failure or cancer, so confidence in these results is low.

The researchers also were able to indirectly compare individual biologics.

These analyses revealed that abatacept and anakinra were associated with a significantly lower risk of serious adverse events than were most other biologics. In addition, certolizumab pegol was associated with significantly greater odds of serious infections than were etanercept, adalimumab, abatacept, anakinra, golimumab, infliximab, and rituximab. Abatacept was significantly less likely than infliximab and tocilizumab to be associated with serious infections; abatacept, adalimumab, etanercept, and golimumab were significantly less likely than infliximab to result in withdrawals due to adverse events.

“There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics,” they concluded.

Major Finding: In the short term, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19), and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Data Source: A meta-analysis of data from 163 randomized controlled trials with 50,010 adult participants and 46 extension studies with 11,954 adult participants.

Disclosures: Dr. Singh and several of his coauthors reported that they have significant financial relationships with several pharmaceutical companies.

Biologics appear to be associated with a significantly greater rate of total adverse events, withdrawals due to adverse events, and an increased risk of tuberculosis reactivation compared with control agents, based on a meta-analysis involving more than 60,000 patients.

However, there were no significant differences in the rates of serious adverse events, serious infections, lymphoma, and congestive heart failure between biologics and control agents, wrote Dr. Jasvinder A. Singh and his coauthors (Cochrane Database Syst. Rev. 2011 [doi: 10.1002/14651858.CD008794.pub2]); http://www2.cochrane.org/reviews/en/ab008794.html

The results come from a network meta-analysis and Cochrane overview of the adverse effects of biologic drugs that are approved for the treatment of rheumatoid arthritis and other conditions in Europe, the United Kingdom, the United States, Canada, and Australia.

The investigators included randomized controlled trials (RCTs), controlled clinical trials, and open-label extension studies that involved one of the nine biologics for use in any indication and that reported this study's prespecified adverse outcomes. The researchers did not include studies on biologics for the treatment of HIV/AIDS. The nine biologics investigated were abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan/MabThera), and tocilizumab (Actemra). They searched the Cochrane Library, Medline, and Embase (through January 2010).

The investigators performed mixed-effects logistic regression using an arm-based, random-effects model within an empirical Bayes framework for the network meta-analysis.

In all, included in the analysis were 163 RCTs with 50,010 adult participants and 46 extension studies with 11,954 adult participants. The median duration was 6 months for the RCTs and 13 months for the extension studies. Given the short duration of the RCTs, all the results should be interpreted as applying to a fairly short time frame.

After the analysis was adjusted for dose, biologics as a group were associated with a significantly greater rate of total adverse events (odds ratio 1.19) and withdrawals due to adverse events (OR 1.32), as well as an increased risk of TB reactivation (OR 4.68), compared with control agents.

Certolizumab pegol was associated with a significantly greater risk of serious infections than was control treatment (OR 3.51), according to the report. Infliximab was associated with a significantly greater risk of withdrawals due to adverse events compared with the control (OR 2.04).

Heart failure and cancer have been of particular concern with the use of biologic drugs.

There appears to be little or no difference in the number of people who experienced heart failure or cancer taking any biologic compared with people who took placebo. However, there were not many cases of congestive heart failure or cancer, so confidence in these results is low.

The researchers also were able to indirectly compare individual biologics.

These analyses revealed that abatacept and anakinra were associated with a significantly lower risk of serious adverse events than were most other biologics. In addition, certolizumab pegol was associated with significantly greater odds of serious infections than were etanercept, adalimumab, abatacept, anakinra, golimumab, infliximab, and rituximab. Abatacept was significantly less likely than infliximab and tocilizumab to be associated with serious infections; abatacept, adalimumab, etanercept, and golimumab were significantly less likely than infliximab to result in withdrawals due to adverse events.

“There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics,” they concluded.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years.

However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis.

Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. “Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR,” the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland. The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted.

View on the News

Focus on Early Intervention

It is important to study the relationships between osteoarthritis and cardiovascular health because both are chronic low-grade inflammatory diseases. The lack of association between severe osteoarthritis and atherosclerosis in the majority of patients in this study is not surprising. We see the same thing with osteoporosis, another disease of aging in which there is low-grade inflammation, which causes a disease over time.

Genetics and diet are some factors that might affect the association between hand OA and atherosclerosis in women, which might have been factors in this study.

There are various challenges to studying the relationship between osteoarthritis and atherosclerosis.

For example, it takes time to see the clinical disease and, because of that, we need to use animal models and try to understand both the disease mechanism and how we might intervene.

When planning future studies, researchers in this area need to talk to each other and design studies to intervene before diseases become clinically apparent.

DR. NANCY LANE is a professor at the University of California, Davis, and director of the UC Davis Center for Healthy Aging. Her specialties include internal medicine, rheumatology, and allergy and clinical immunology. She said she had no relevant financial disclosures.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years.

However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis.

Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. “Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR,” the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland. The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted.

View on the News

Focus on Early Intervention

It is important to study the relationships between osteoarthritis and cardiovascular health because both are chronic low-grade inflammatory diseases. The lack of association between severe osteoarthritis and atherosclerosis in the majority of patients in this study is not surprising. We see the same thing with osteoporosis, another disease of aging in which there is low-grade inflammation, which causes a disease over time.

Genetics and diet are some factors that might affect the association between hand OA and atherosclerosis in women, which might have been factors in this study.

There are various challenges to studying the relationship between osteoarthritis and atherosclerosis.

For example, it takes time to see the clinical disease and, because of that, we need to use animal models and try to understand both the disease mechanism and how we might intervene.

When planning future studies, researchers in this area need to talk to each other and design studies to intervene before diseases become clinically apparent.

DR. NANCY LANE is a professor at the University of California, Davis, and director of the UC Davis Center for Healthy Aging. Her specialties include internal medicine, rheumatology, and allergy and clinical immunology. She said she had no relevant financial disclosures.

Adults who underwent total joint replacement of the hip or knee were not significantly more likely to have atherosclerosis, based on data from 5,170 adults with an average age of 76 years.

However, women who had a total joint replacement and hand osteoarthritis were significantly more likely to have atherosclerosis.

Dr. Helgi Jonsson of the University of Iceland in Reykjavik and colleagues used total joint replacement (TJR) as an indicator of severe osteoarthritis (Ann. Rheum. Dis. 2011 [doi:10.1136/ard.2010.144980]). The study population included 2,195 men and 2,975 women; 539 patients had total joint replacement, including 316 with total hip replacements (THR), 223 with total knee replacements (TKR), and 31 with both hip and knee replacements.

Overall, women who had a joint replacement showed a nonsignificant trend toward increased coronary calcifications and carotid plaques, but no such associations were seen in men. “Apart from marginally increased aortic calcium in women with TKR, there were no statistical differences in those with and without TKR and THR,” the researchers noted.

But the researchers saw a significant upward trend in coronary calcifications among women with hand osteoarthritis (HOA). The difference between the average value of women without either TJR or HOA and the women with both TJR and HOA was significant – approximately 10% – for three markers of atherosclerosis: coronary calcium, periventricular white matter hyperintensities, and carotid plaque.

The data were taken from a subset of older patients in the AGES–Reykjavik Study, a population-based study conducted in Iceland. The results support findings from previous studies suggesting a link between osteoarthritis and atherosclerosis in women, the researchers noted.

View on the News

Focus on Early Intervention

It is important to study the relationships between osteoarthritis and cardiovascular health because both are chronic low-grade inflammatory diseases. The lack of association between severe osteoarthritis and atherosclerosis in the majority of patients in this study is not surprising. We see the same thing with osteoporosis, another disease of aging in which there is low-grade inflammation, which causes a disease over time.

Genetics and diet are some factors that might affect the association between hand OA and atherosclerosis in women, which might have been factors in this study.

There are various challenges to studying the relationship between osteoarthritis and atherosclerosis.

For example, it takes time to see the clinical disease and, because of that, we need to use animal models and try to understand both the disease mechanism and how we might intervene.

When planning future studies, researchers in this area need to talk to each other and design studies to intervene before diseases become clinically apparent.

DR. NANCY LANE is a professor at the University of California, Davis, and director of the UC Davis Center for Healthy Aging. Her specialties include internal medicine, rheumatology, and allergy and clinical immunology. She said she had no relevant financial disclosures.

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

Major Finding: Previous treatment with rituximab does not increase infection risk in RA patients who subsequently receive other biologic therapies during the period of peripheral B-cell depletion.

Data Source: A subgroup analysis of patients with moderate to severe RA who received rituximab as part of an international clinical trial program.

Disclosures: Dr. Genovese disclosed receiving research grants and consulting fees from Ardea, Genentech, Horizon, Lilly, Rigel, and Synarc.

CANCÚN, MEXICO – The use of other biologic therapies in rheumatoid arthritis patients previously treated with rituximab has been shown to not be associated with an increased risk of serious infection in this population.

“The rate of serious infections [in these patients] is consistent with rates observed in long-term safety analyses of rituximab-treated patients,” reported Dr. Mark C. Genovese.

The study was designed to determine whether residual pharmacodynamic effects following discontinuation of rituximab render rheumatoid arthritis patients more vulnerable to serious infection during subsequent biologic treatment.

To make that determination, Dr. Genovese, professor of medicine (immunology and rheumatology) at Stanford (Calif.) University, and his colleagues reviewed the outcomes of patients with moderate to severe RA who received rituximab and methotrexate in an international clinical trial program and who were subsequently treated with a different biologic during the safety follow-up period.

Of the 3,189 RA patients who had received at least one course of rituximab in the clinical trial, 283 were subsequently treated with an alternative biologic agent during safety follow-up, according to Dr. Genovese.

Of these, 230 patients received tumor necrosis factor (TNF) inhibitors as their first subsequent biologic agent after rituximab.

Another 43 received the T-cell inhibitor abatacept (including 2 who subsequently received a TNF inhibitor), 9 received the interleukin-1 inhibitor anakinra (also including 2 who subsequently received a TNF inhibitor), 3 received the interleukin-6 receptor inhibitor tocilizumab, and 2 received experimental biologic agents.

The median time from the last dose of rituximab to the first subsequent biologic was 8 months (mean 10 months), he reported. The average follow-up time after receiving the subsequent biologic was 11 months.

The investigators collected information on “serious infection events,” defined as infections that required intravenous antibiotics or met the regulatory criteria for a serious adverse event, including infections that required inpatient hospitalization; were immediately life-threatening; were medically significant and required an intervention to prevent one of the previous outcomes; or were fatal.

They calculated the rates of such events for the periods in which patients were on rituximab before the subsequent biologic and after initiation of treatment with the subsequent biologic, Dr. Genovese said.

They also collected peripheral CD19+ counts, which are a surrogate marker for CD20+ B cells.

Following the first dose of rituximab and prior to subsequent biologic therapy, 22 serious infections in 18 patients over 366 patient-years of follow-up (6 events/100 patient-years) were reported. “The infections were variable and typical of RA patients, and did not include any opportunistic or fatal infections,” Dr. Genovese said.

At the time of receiving subsequent biologic treatment, 83% of the patients had peripheral B-cell counts below the lower limit of normal, he noted.

After treatment with another biologic following rituximab, a total of 16 serious infection events – also variable and typical of RA – occurred in 15 patients over 321,64 patient-years of follow-up (5 events/100 patient-years).

The median time to infection after initiating the subsequent biologic was 11 months, he said.

Of the 16 serious infection events, 12 occurred in patients who had received TNF inhibitors as their first post-rituximab biologic, and 4 occurred in patients who had received two biologic drugs post rituximab, said Dr. Genovese.

One serious infection was reported before alternative treatment and one after treatment among the 43 patients who received abatacept, according to Dr. Genovese.

In the subgroup of patients who received a TNF inhibitor following rituximab, the serious infection rates before and after receipt of the drug were 6.03/100 patient-years and 4.51/100 patient-years, respectively.

Overall, the serious infection rates in the 283 patients were statistically similar to the rate of 4.35 events/100 patient-years observed in the all-exposure safety population, according to Dr. Genovese's presentation.

In the subgroup of patients with CD19+ cell counts of less than 20 cells/mcL prior to subsequent biologic treatment, the serious infection rate, found to be at 6 events/100 patient-years, was also consistent with the serious infection rates observed in all patients who were receiving any biologic disease-modifying antirheumatic drug following rituximab, he said.

“The findings answer an important clinical question about the safety of treatment with other biologic drugs during the period of peripheral B-cell depletion in patients who have discontinued rituximab,” Dr. Genovese concluded.

Despite its peripheral B-cell depletion, rituximab does not up infection rates with subsequent biologics.

Source DR. GENOVESE

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

CANCÚN, MEXICO – Most ankylosing spondylitis patients who have elevated disease activity and inflammatory back pain that is not controlled with conventional therapy have been shown to respond to anti–tumor necrosis factor therapy, according to findings from a recent study.

Importantly, “disease activity will most likely not result in improvement,” Dr. Nathan Vastesaeger reported at the meeting. As such, “the treating physician should consider a defined trial period with a TNF inhibitor if disease activity is not controlled with conventional therapy,” he said.

Specifically, patient age, peripheral enthesitis measure, C-reactive protein (CRP) level, functionality, and human leukocyte antigen B27 (HLA-B27) genotype are also associated with the likelihood that a patient with ankylosing spondylitis (AS) will respond to anti-TNF, reported Dr. Vastesaeger.

The findings are based on analysis of data, separately and combined, from two randomized controlled trials to model the probability of achieving response or remission after initiating anti-TNF therapy or continuing conventional therapy with NSAIDs, disease-modifying anti-rheumatic drugs (DMARDs), or steroids for AS, said Dr. Vastesaeger of Schering-Plough.

The two studies included in the analysis were the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial and the GO-RAISE (Golimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection Given Every Four Weeks) trial.

The two studies combined comprised 479 AS patients treated with anti-TNF drugs and 156 AS patients treated with placebo and continued conventional therapy. All of the patients included in the analysis had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of at least 4 and spinal pain assessment scores of at least 4.

The prediction model incorporated patient age, enthesitis score, CRP level, Bath AS Functional Index (BASFI) score, and HLA-B27 genotype. The mean age of the patients included in the analysis was 39.5 years, and the mean BASFI, CRP, and enthesitis measures were 5.4, 2.1, and 2.4, respectively.

For the ASSERT, GO-RAISE, and combined data, the area under the ROC curve for 50% improvement in BASDAI score (BASDAI50) at 12 weeks was 82%, 75%, and 77%, respectively, and for Assessment in AS (ASAS) partial remission at 24 weeks was 80%, 77%, and 78%, reported Dr. Vastesaeger. When the data were categorized by age (40 years or younger vs. older than 40 years), enthesitis score (0 vs. greater than 0), CRP level (0.6 mg/dL or less, greater than 0.6-2 mg/dL, and greater than 2 mg/dL), and BASFI score (4.5 or less, greater than 4.5-6.5, and greater than 6.5), “the area under the curve of the combined data set prediction model was 80% for [BASDAI50] response and 77% for [ASAS] partial remission,” he reported. “This suggests a good prediction model according to the academic point system.”

In a matrix model designed to represent increasing proportion of BASDAI50 response and ASAS partial remission with respect to baseline characteristics, “only 2% of patients who did not have BASDAI50 response at week 12 had ASAS partial remission at week 24,” said Dr. Vastesaeger.

The development of the matrix model was reported by Dr. Vastesaeger and his coinvestigators in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011 March 14 [doi:10.1136/ard.2010.147744]).

Dr. Vastesaeger is an employee of Schering-Plough. He reported having no conflicts of interest with respect to this presentation.

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”

Major Finding: An accelerated rituximab infusion protocol was safe and well tolerated among patients with rheumatoid arthritis.

Data Source: A 10-patient prospective, open-label study designed to assess the practicality of a rapid-infusion protocol for rituximab in RA patients in a single community setting.

Disclosures: Dr. Faraawi reported that he had no relevant financial disclosures.

CANCUN, MEXICO – An accelerated rituximab infusion for rheumatoid arthritis is safe and well tolerated in the community setting, a study has shown.

Moreover, the rapid infusion protocol “optimizes resources in busy rheumatology practices,” Dr. Rafat Faraawi said at the meeting.

As a chimeric monoclonal antibody, rituximab (Rituxan) is often associated with infusion toxicities, particularly during the initial 30-120 minutes of the first infusion, said Dr. Faraawi, a rheumatologist at St. Mary's General Hospital in Kitchener, Ont.

To minimize the potential for infusion-related events, the drug manufacturers recommend that it be infused slowly, over the course of 4-5 hours – a long duration that is highly resource intensive, particularly in this era of intense competition for “chair time” and nursing attention, he said.

Small pilot studies in the oncology setting have shown that rapid rituximab infusion protocols of 60-90 minutes can be administered safely without increasing the risk of infusion-related reactions.

To evaluate the practicality, safety, and tolerability of an accelerated-infusion protocol in the rheumatology setting, Dr. Faraawi and his colleagues recruited 10 patients who were prescribed rituximab for their rheumatoid arthritis to participate in the investigation. The protocol comprised two courses of 1,000-mg infusions given 2 weeks apart. The first infusion followed the recommended 225-minute infusion schedule, while the subsequent infusions were administered over a period of 120 minutes as follows: 100 mg over 0-30 minutes; 200 mg over 30-60 minutes; 300 mg over 60-90 minutes; and 400 mg over 90-120 minutes, he said.

Prior to the infusions, patients were premedicated with 1,000 mg acetaminophen, 50 mg diphenhydramine, and 100 mg intravenous methylprednisolone. Vital signs were recorded at baseline and at 15, 30, 60, 90, and 120 minutes, said Dr. Faraawi.

The mean age and disease duration of the 10 patients was 50.6 years and 11.4 years, and the mean disease activity score at the first rituximab infusion was 5.9, he reported.

At the time of the presentation, a total of 40 infusions had been administered, 30 of which followed the accelerated-infusion protocol, said Dr. Faraawi. “To date, the rapid infusion of rituximab has been well tolerated by all of the patients, with only one mild infusion reaction, which resolved during the infusion,” he said. “In that case, the patient had refused premedication before the third infusion and experienced itching in her throat and ears, sore shoulders, and tremors, all of which resolved following treatment with intravenous diphenhydramine and methylprednisolone and oral acetaminophen.” The patient premedicated prior to subsequent infusions and had no further reactions, Dr. Faraawi said.

Based on the positive findings of this small study, “rapid rituximab infusion is a practical option in a community setting,” he said.

“All of the patients were satisfied with the short infusion duration, it was safe and well tolerated, and it optimized patient, nurse, and physician time.”