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Alefacept Boosts Response To Methotrexate in Patients With Psoriatic Arthritis
CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.
This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.
Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.
In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.
At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.
At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.
Results on both efficacy end points were statistically significant, he said.
The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.
Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.
In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.
Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.
The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.
Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.
Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.
Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.
This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.
Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.
In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.
At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.
At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.
Results on both efficacy end points were statistically significant, he said.
The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.
Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.
In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.
Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.
The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.
Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.
Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.
Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.
This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.
Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.
In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.
At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.
At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.
Results on both efficacy end points were statistically significant, he said.
The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.
Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.
In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.
Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.
The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.
Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.
Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.
Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
Quantitative MRI Assessment Method Looks at Whole OA Joint
DESTIN, FLA. — While MRI applications for evaluating osteoarthritis are currently limited, methods are being developed that will eventually enable quantitative assessment of the disease, according to Charles Peterfy, M.D., who spoke at a rheumatology meeting sponsored by Virginia Commonwealth University.
Current applications of MRI including its use to noninvasively guide cartilage repair. The high-resolution delineation of cartilage defects and abnormalities that MRI provides can help guide patient selection and preoperative planning. Postoperatively, MRI can be used to monitor the integrity and durability of the repair, said Dr. Peterfy, a radiologist specializing in musculoskeletal imaging and the chief medical officer of Synarc Inc., a radiology services company.
In addition, newer applications of MRI “allow us, for the first time, to visualize all of the components of the joint simultaneously,” he said. MRI can be used to visualize menisci, ligaments, synovitis, bone abnormalities, and periarticular abnormalities.
The result is that instead of assessing in an isolated fashion any one aspect of the disease's effect, physicians can analyze the whole joint. This approach is facilitated by the development of a semiquantitative scoring system for evaluating osteoarthritis using MRI. Dr. Peterfy was one of the authors of the Whole-Organ Magnetic Resonance Imaging Score (WORMS) method for assessing the structural integrity of the knee.
The WORMS method can be used to evaluate independent articular features including: cartilage signal and morphology, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, marginal osteophytes, medial and lateral meniscal integrity, anterior and posterior cruciate ligament integrity, medial and lateral collateral ligament integrity, synovitis, loose bodies, and periarticular cysts/bursae.
One the most promising areas of MRI research centers around bone marrow edema-like abnormalities. These edema-like signals may represent pulsion of joint fluid through breaks in the articular surface, localized inflammation, or changes associated with trauma due to biomechanical incompetence of the articular surface.
Whatever their etiology, bone marrow edema abnormalities behave like microtrauma, said Dr. Peterfy, who is also on the advisory board for MagneVu, the maker of portable MRI units.
Using a WORMS-like evaluation method, bone marrow edema abnormalities have been shown to correlate with pain and collagen II breakdown and even to predict joint space narrowing on x-ray, and cartilage narrowing. In addition, these findings have been shown to progress very rapidly—even in as few as 3 months.
In a study of 378 patients treated at several clinical centers worldwide, 82% had bone marrow abnormalities on MRI at baseline (as scored on the bone marrow subscale of WORMS), said Dr. Peterfy. The patients were followed for 3 months, at which time, 34% of those with baseline abnormalities had progression of these abnormalities. This change correlated well with urine concentrations of collagen type II degradation product (CTXII), which results from cartilage breakdown (Arthritis Rheum. 2005 [in press]).
DESTIN, FLA. — While MRI applications for evaluating osteoarthritis are currently limited, methods are being developed that will eventually enable quantitative assessment of the disease, according to Charles Peterfy, M.D., who spoke at a rheumatology meeting sponsored by Virginia Commonwealth University.
Current applications of MRI including its use to noninvasively guide cartilage repair. The high-resolution delineation of cartilage defects and abnormalities that MRI provides can help guide patient selection and preoperative planning. Postoperatively, MRI can be used to monitor the integrity and durability of the repair, said Dr. Peterfy, a radiologist specializing in musculoskeletal imaging and the chief medical officer of Synarc Inc., a radiology services company.
In addition, newer applications of MRI “allow us, for the first time, to visualize all of the components of the joint simultaneously,” he said. MRI can be used to visualize menisci, ligaments, synovitis, bone abnormalities, and periarticular abnormalities.
The result is that instead of assessing in an isolated fashion any one aspect of the disease's effect, physicians can analyze the whole joint. This approach is facilitated by the development of a semiquantitative scoring system for evaluating osteoarthritis using MRI. Dr. Peterfy was one of the authors of the Whole-Organ Magnetic Resonance Imaging Score (WORMS) method for assessing the structural integrity of the knee.
The WORMS method can be used to evaluate independent articular features including: cartilage signal and morphology, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, marginal osteophytes, medial and lateral meniscal integrity, anterior and posterior cruciate ligament integrity, medial and lateral collateral ligament integrity, synovitis, loose bodies, and periarticular cysts/bursae.
One the most promising areas of MRI research centers around bone marrow edema-like abnormalities. These edema-like signals may represent pulsion of joint fluid through breaks in the articular surface, localized inflammation, or changes associated with trauma due to biomechanical incompetence of the articular surface.
Whatever their etiology, bone marrow edema abnormalities behave like microtrauma, said Dr. Peterfy, who is also on the advisory board for MagneVu, the maker of portable MRI units.
Using a WORMS-like evaluation method, bone marrow edema abnormalities have been shown to correlate with pain and collagen II breakdown and even to predict joint space narrowing on x-ray, and cartilage narrowing. In addition, these findings have been shown to progress very rapidly—even in as few as 3 months.
In a study of 378 patients treated at several clinical centers worldwide, 82% had bone marrow abnormalities on MRI at baseline (as scored on the bone marrow subscale of WORMS), said Dr. Peterfy. The patients were followed for 3 months, at which time, 34% of those with baseline abnormalities had progression of these abnormalities. This change correlated well with urine concentrations of collagen type II degradation product (CTXII), which results from cartilage breakdown (Arthritis Rheum. 2005 [in press]).
DESTIN, FLA. — While MRI applications for evaluating osteoarthritis are currently limited, methods are being developed that will eventually enable quantitative assessment of the disease, according to Charles Peterfy, M.D., who spoke at a rheumatology meeting sponsored by Virginia Commonwealth University.
Current applications of MRI including its use to noninvasively guide cartilage repair. The high-resolution delineation of cartilage defects and abnormalities that MRI provides can help guide patient selection and preoperative planning. Postoperatively, MRI can be used to monitor the integrity and durability of the repair, said Dr. Peterfy, a radiologist specializing in musculoskeletal imaging and the chief medical officer of Synarc Inc., a radiology services company.
In addition, newer applications of MRI “allow us, for the first time, to visualize all of the components of the joint simultaneously,” he said. MRI can be used to visualize menisci, ligaments, synovitis, bone abnormalities, and periarticular abnormalities.
The result is that instead of assessing in an isolated fashion any one aspect of the disease's effect, physicians can analyze the whole joint. This approach is facilitated by the development of a semiquantitative scoring system for evaluating osteoarthritis using MRI. Dr. Peterfy was one of the authors of the Whole-Organ Magnetic Resonance Imaging Score (WORMS) method for assessing the structural integrity of the knee.
The WORMS method can be used to evaluate independent articular features including: cartilage signal and morphology, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, marginal osteophytes, medial and lateral meniscal integrity, anterior and posterior cruciate ligament integrity, medial and lateral collateral ligament integrity, synovitis, loose bodies, and periarticular cysts/bursae.
One the most promising areas of MRI research centers around bone marrow edema-like abnormalities. These edema-like signals may represent pulsion of joint fluid through breaks in the articular surface, localized inflammation, or changes associated with trauma due to biomechanical incompetence of the articular surface.
Whatever their etiology, bone marrow edema abnormalities behave like microtrauma, said Dr. Peterfy, who is also on the advisory board for MagneVu, the maker of portable MRI units.
Using a WORMS-like evaluation method, bone marrow edema abnormalities have been shown to correlate with pain and collagen II breakdown and even to predict joint space narrowing on x-ray, and cartilage narrowing. In addition, these findings have been shown to progress very rapidly—even in as few as 3 months.
In a study of 378 patients treated at several clinical centers worldwide, 82% had bone marrow abnormalities on MRI at baseline (as scored on the bone marrow subscale of WORMS), said Dr. Peterfy. The patients were followed for 3 months, at which time, 34% of those with baseline abnormalities had progression of these abnormalities. This change correlated well with urine concentrations of collagen type II degradation product (CTXII), which results from cartilage breakdown (Arthritis Rheum. 2005 [in press]).
ACR's Tender Point Criteria for Fibromyalgia Flawed, Expert Says
DESTIN, FLA. — The tender point criteria commonly used to diagnose fibromyalgia are not useful and in fact may even explain why the disease appears to disproportionately affect women, said Daniel Clauw, M.D., speaking at a rheumatology meeting sponsored by Virginia Commonwealth University.
According to the American College of Rheumatology's 1990 classification criteria, patients must have both widespread pain and tenderness in 11 of 18 tender points in order to be diagnosed with fibromyalgia.
Yet “tender points merely represent areas of the body where everyone is more tender,” explained Dr. Clauw, the executive director of the Chronic Pain and Fatigue Research Center at the University of Michigan in Ann Arbor. Fibromyalgia patients and healthy individuals were found to have different thresholds of pain in those tender points. These two groups also had different thresholds of pain in areas not thought to be tender—the forehead and fingernails, for example—as at the recognized tender points. In addition, the cutoff of 11 out of 18 tender points is arbitrary. “We know that tenderness varies a great deal from day to day and week to week, especially in women,” he said.
In clinical practice, many physicians are realizing the arbitrary nature of the diagnostic criteria. The diminished role of tender points represents a shift in the way that they view the disorder. In the past, the disorder was considered a discrete illness with pain and focal areas of tenderness. In more recent years, fibromyalgia has been appreciated as part of a larger continuum, with many somatic symptoms and diffuse tenderness all over the body—not just at tender points.
Tender points are “not even a good way to measure tenderness,” as study findings suggest that the number of tender points correlates better with a patient's general stress than with pain, Dr. Clauw pointed out.
DESTIN, FLA. — The tender point criteria commonly used to diagnose fibromyalgia are not useful and in fact may even explain why the disease appears to disproportionately affect women, said Daniel Clauw, M.D., speaking at a rheumatology meeting sponsored by Virginia Commonwealth University.
According to the American College of Rheumatology's 1990 classification criteria, patients must have both widespread pain and tenderness in 11 of 18 tender points in order to be diagnosed with fibromyalgia.
Yet “tender points merely represent areas of the body where everyone is more tender,” explained Dr. Clauw, the executive director of the Chronic Pain and Fatigue Research Center at the University of Michigan in Ann Arbor. Fibromyalgia patients and healthy individuals were found to have different thresholds of pain in those tender points. These two groups also had different thresholds of pain in areas not thought to be tender—the forehead and fingernails, for example—as at the recognized tender points. In addition, the cutoff of 11 out of 18 tender points is arbitrary. “We know that tenderness varies a great deal from day to day and week to week, especially in women,” he said.
In clinical practice, many physicians are realizing the arbitrary nature of the diagnostic criteria. The diminished role of tender points represents a shift in the way that they view the disorder. In the past, the disorder was considered a discrete illness with pain and focal areas of tenderness. In more recent years, fibromyalgia has been appreciated as part of a larger continuum, with many somatic symptoms and diffuse tenderness all over the body—not just at tender points.
Tender points are “not even a good way to measure tenderness,” as study findings suggest that the number of tender points correlates better with a patient's general stress than with pain, Dr. Clauw pointed out.
DESTIN, FLA. — The tender point criteria commonly used to diagnose fibromyalgia are not useful and in fact may even explain why the disease appears to disproportionately affect women, said Daniel Clauw, M.D., speaking at a rheumatology meeting sponsored by Virginia Commonwealth University.
According to the American College of Rheumatology's 1990 classification criteria, patients must have both widespread pain and tenderness in 11 of 18 tender points in order to be diagnosed with fibromyalgia.
Yet “tender points merely represent areas of the body where everyone is more tender,” explained Dr. Clauw, the executive director of the Chronic Pain and Fatigue Research Center at the University of Michigan in Ann Arbor. Fibromyalgia patients and healthy individuals were found to have different thresholds of pain in those tender points. These two groups also had different thresholds of pain in areas not thought to be tender—the forehead and fingernails, for example—as at the recognized tender points. In addition, the cutoff of 11 out of 18 tender points is arbitrary. “We know that tenderness varies a great deal from day to day and week to week, especially in women,” he said.
In clinical practice, many physicians are realizing the arbitrary nature of the diagnostic criteria. The diminished role of tender points represents a shift in the way that they view the disorder. In the past, the disorder was considered a discrete illness with pain and focal areas of tenderness. In more recent years, fibromyalgia has been appreciated as part of a larger continuum, with many somatic symptoms and diffuse tenderness all over the body—not just at tender points.
Tender points are “not even a good way to measure tenderness,” as study findings suggest that the number of tender points correlates better with a patient's general stress than with pain, Dr. Clauw pointed out.
EULAR Straddles the Data-Opinion Gap on Hip OA
New recommendations from the European League Against Rheumatism on the management of hip osteoarthritis come from two camps—the best available research evidence, and expert opinion/current practice—and these camps are not always in agreement.
Discordances between expert opinion and the literature demonstrate the need for more clinical trial data specifically on hip osteoarthritis (OA) and make EULAR's 10 treatment recommendations truly an “open recommendation set” that should provide a frame of reference for physicians, said Maxime Dougados, M.D., who led the multidisciplinary task force that wrote the recommendations.
“We provide 10 take-home messages, but without providing any strict guidelines or a treatment algorithm,” said Dr. Dougados, chief of rheumatology at the Hospital Cochin in Paris.
Total hip replacement is not supported by strong research evidence, for instance, but “nevertheless, all the experts consider it of clinical benefit,” he said.
In their report, he and his colleagues note that “more clinical trial data specific to hip OA are required, especially because some interventions appear to show different efficacy according to the joint site” (Ann. Rheum. Dis. 2005;64:669–81).
Despite shortcomings in research, the recommendations are useful and “eminently reasonable,” said Marc C. Hochberg, M.D., who helped develop the American College of Rheumatology's recommendations for managing osteoarthritis of the hip and knee. ACR's recommendations were published in 2000.
The recommendations, each of which includes an analysis of cost effectiveness, indicate that optimal management of hip OA should be individually tailored; that it requires a combination of nonpharmacologic and pharmacologic treatment modalities; and that nonpharmacologic treatment should include education, exercise, devices such as insoles, and weight reduction if necessary.
The experts were asked to assess separately the strength of each intervention based on research evidence and clinical expertise. Of the 21 interventions reviewed in the new recommendations, 15 were positively supported by evidence of various grades. However, only 15% of the hip OA studies were randomized controlled trials.
Here's a look at some of the recommendations:
▸ Acetaminophen is the oral analgesic of first choice for mild to moderate pain, and if successful, is the preferred long-term oral analgesic.
▸ NSAIDs should be added or substituted, at the lowest effective dose, in patients who respond inadequately to paracetamol. In patients with increased gastrointestinal risk, nonselective NSAIDS plus a gastroprotective agent, or a selective cyclooxygenase-2 inhibitor, should be used.
▸ Opioid analgesics, with or without acetaminophen, are useful alternatives in patients in whom NSAIDS (including coxibs) are contraindicated, ineffective, and/or poorly tolerated.
▸ Joint replacement has to be considered in patients with radiographic evidence of hip OA who have refractory pain and disability.
▸ Osteotomy and joint preserving surgical procedures should be considered in young adults with symptomatic hip OA, especially in the presence of dysplasia or varus/valgus deformity.
▸ Diacerhein and avocado soybean unsaponifiable (ASU) were found to “have a symptomatic effect and low toxicity.” However, their “effect sizes are small, suitable patients are not well defined, and structure-modifying effects are not well established,” according to the recommendations. In any case, such guidance has limited applicability in the United States, given the lack of availability of these two compounds, noted Dr. Hochberg, head of rheumatology and clinical immunology at the University of Maryland.
Three interventions—acetaminophen, glucosamine, and exercise—had no direct, hip-specific evidence to support their use, and another three interventions—ASU, diacerhein, and intraarticular steroid injection—had either evidence showing no symptomatic benefit or inconclusive evidence. Still, based on clinical experience, these treatments were deemed effective and have been recommended for knee OA.
“There may be true treatment differences for OA according to the site affected,” wrote the task force members, who had excluded from the literature review most of the studies that combined hip and knee OA.
Acetaminophen—one of the three interventions with no direct efficacy data—received a relatively high mean “strength of recommendation” rating (79%) based on clinical expertise, for instance.
Total hip replacement was similar: It received a low “strength of recommendation” rating based on research evidence (a C on an A-D scale), but a high rating (86%) based on clinical expertise.
Opioids, on the other hand, received a high rating (A on an A-D scale) based on research evidence but a low rating (44%) based on clinical expertise. NSAIDs were rated highly with respect both to research evidence of efficacy (A) and to clinical expertise (80%).
“It's clear now that NSAIDs might have a controversial toxicity,” said Dr. Dougados in an interview. “But these drugs are very powerful and very efficient. I think prescriptions will continue but with more emphasis on decreasing dose and duration.”
We [need to] answer the question of when exactly to recommend and perform THR.
New recommendations from the European League Against Rheumatism on the management of hip osteoarthritis come from two camps—the best available research evidence, and expert opinion/current practice—and these camps are not always in agreement.
Discordances between expert opinion and the literature demonstrate the need for more clinical trial data specifically on hip osteoarthritis (OA) and make EULAR's 10 treatment recommendations truly an “open recommendation set” that should provide a frame of reference for physicians, said Maxime Dougados, M.D., who led the multidisciplinary task force that wrote the recommendations.
“We provide 10 take-home messages, but without providing any strict guidelines or a treatment algorithm,” said Dr. Dougados, chief of rheumatology at the Hospital Cochin in Paris.
Total hip replacement is not supported by strong research evidence, for instance, but “nevertheless, all the experts consider it of clinical benefit,” he said.
In their report, he and his colleagues note that “more clinical trial data specific to hip OA are required, especially because some interventions appear to show different efficacy according to the joint site” (Ann. Rheum. Dis. 2005;64:669–81).
Despite shortcomings in research, the recommendations are useful and “eminently reasonable,” said Marc C. Hochberg, M.D., who helped develop the American College of Rheumatology's recommendations for managing osteoarthritis of the hip and knee. ACR's recommendations were published in 2000.
The recommendations, each of which includes an analysis of cost effectiveness, indicate that optimal management of hip OA should be individually tailored; that it requires a combination of nonpharmacologic and pharmacologic treatment modalities; and that nonpharmacologic treatment should include education, exercise, devices such as insoles, and weight reduction if necessary.
The experts were asked to assess separately the strength of each intervention based on research evidence and clinical expertise. Of the 21 interventions reviewed in the new recommendations, 15 were positively supported by evidence of various grades. However, only 15% of the hip OA studies were randomized controlled trials.
Here's a look at some of the recommendations:
▸ Acetaminophen is the oral analgesic of first choice for mild to moderate pain, and if successful, is the preferred long-term oral analgesic.
▸ NSAIDs should be added or substituted, at the lowest effective dose, in patients who respond inadequately to paracetamol. In patients with increased gastrointestinal risk, nonselective NSAIDS plus a gastroprotective agent, or a selective cyclooxygenase-2 inhibitor, should be used.
▸ Opioid analgesics, with or without acetaminophen, are useful alternatives in patients in whom NSAIDS (including coxibs) are contraindicated, ineffective, and/or poorly tolerated.
▸ Joint replacement has to be considered in patients with radiographic evidence of hip OA who have refractory pain and disability.
▸ Osteotomy and joint preserving surgical procedures should be considered in young adults with symptomatic hip OA, especially in the presence of dysplasia or varus/valgus deformity.
▸ Diacerhein and avocado soybean unsaponifiable (ASU) were found to “have a symptomatic effect and low toxicity.” However, their “effect sizes are small, suitable patients are not well defined, and structure-modifying effects are not well established,” according to the recommendations. In any case, such guidance has limited applicability in the United States, given the lack of availability of these two compounds, noted Dr. Hochberg, head of rheumatology and clinical immunology at the University of Maryland.
Three interventions—acetaminophen, glucosamine, and exercise—had no direct, hip-specific evidence to support their use, and another three interventions—ASU, diacerhein, and intraarticular steroid injection—had either evidence showing no symptomatic benefit or inconclusive evidence. Still, based on clinical experience, these treatments were deemed effective and have been recommended for knee OA.
“There may be true treatment differences for OA according to the site affected,” wrote the task force members, who had excluded from the literature review most of the studies that combined hip and knee OA.
Acetaminophen—one of the three interventions with no direct efficacy data—received a relatively high mean “strength of recommendation” rating (79%) based on clinical expertise, for instance.
Total hip replacement was similar: It received a low “strength of recommendation” rating based on research evidence (a C on an A-D scale), but a high rating (86%) based on clinical expertise.
Opioids, on the other hand, received a high rating (A on an A-D scale) based on research evidence but a low rating (44%) based on clinical expertise. NSAIDs were rated highly with respect both to research evidence of efficacy (A) and to clinical expertise (80%).
“It's clear now that NSAIDs might have a controversial toxicity,” said Dr. Dougados in an interview. “But these drugs are very powerful and very efficient. I think prescriptions will continue but with more emphasis on decreasing dose and duration.”
We [need to] answer the question of when exactly to recommend and perform THR.
New recommendations from the European League Against Rheumatism on the management of hip osteoarthritis come from two camps—the best available research evidence, and expert opinion/current practice—and these camps are not always in agreement.
Discordances between expert opinion and the literature demonstrate the need for more clinical trial data specifically on hip osteoarthritis (OA) and make EULAR's 10 treatment recommendations truly an “open recommendation set” that should provide a frame of reference for physicians, said Maxime Dougados, M.D., who led the multidisciplinary task force that wrote the recommendations.
“We provide 10 take-home messages, but without providing any strict guidelines or a treatment algorithm,” said Dr. Dougados, chief of rheumatology at the Hospital Cochin in Paris.
Total hip replacement is not supported by strong research evidence, for instance, but “nevertheless, all the experts consider it of clinical benefit,” he said.
In their report, he and his colleagues note that “more clinical trial data specific to hip OA are required, especially because some interventions appear to show different efficacy according to the joint site” (Ann. Rheum. Dis. 2005;64:669–81).
Despite shortcomings in research, the recommendations are useful and “eminently reasonable,” said Marc C. Hochberg, M.D., who helped develop the American College of Rheumatology's recommendations for managing osteoarthritis of the hip and knee. ACR's recommendations were published in 2000.
The recommendations, each of which includes an analysis of cost effectiveness, indicate that optimal management of hip OA should be individually tailored; that it requires a combination of nonpharmacologic and pharmacologic treatment modalities; and that nonpharmacologic treatment should include education, exercise, devices such as insoles, and weight reduction if necessary.
The experts were asked to assess separately the strength of each intervention based on research evidence and clinical expertise. Of the 21 interventions reviewed in the new recommendations, 15 were positively supported by evidence of various grades. However, only 15% of the hip OA studies were randomized controlled trials.
Here's a look at some of the recommendations:
▸ Acetaminophen is the oral analgesic of first choice for mild to moderate pain, and if successful, is the preferred long-term oral analgesic.
▸ NSAIDs should be added or substituted, at the lowest effective dose, in patients who respond inadequately to paracetamol. In patients with increased gastrointestinal risk, nonselective NSAIDS plus a gastroprotective agent, or a selective cyclooxygenase-2 inhibitor, should be used.
▸ Opioid analgesics, with or without acetaminophen, are useful alternatives in patients in whom NSAIDS (including coxibs) are contraindicated, ineffective, and/or poorly tolerated.
▸ Joint replacement has to be considered in patients with radiographic evidence of hip OA who have refractory pain and disability.
▸ Osteotomy and joint preserving surgical procedures should be considered in young adults with symptomatic hip OA, especially in the presence of dysplasia or varus/valgus deformity.
▸ Diacerhein and avocado soybean unsaponifiable (ASU) were found to “have a symptomatic effect and low toxicity.” However, their “effect sizes are small, suitable patients are not well defined, and structure-modifying effects are not well established,” according to the recommendations. In any case, such guidance has limited applicability in the United States, given the lack of availability of these two compounds, noted Dr. Hochberg, head of rheumatology and clinical immunology at the University of Maryland.
Three interventions—acetaminophen, glucosamine, and exercise—had no direct, hip-specific evidence to support their use, and another three interventions—ASU, diacerhein, and intraarticular steroid injection—had either evidence showing no symptomatic benefit or inconclusive evidence. Still, based on clinical experience, these treatments were deemed effective and have been recommended for knee OA.
“There may be true treatment differences for OA according to the site affected,” wrote the task force members, who had excluded from the literature review most of the studies that combined hip and knee OA.
Acetaminophen—one of the three interventions with no direct efficacy data—received a relatively high mean “strength of recommendation” rating (79%) based on clinical expertise, for instance.
Total hip replacement was similar: It received a low “strength of recommendation” rating based on research evidence (a C on an A-D scale), but a high rating (86%) based on clinical expertise.
Opioids, on the other hand, received a high rating (A on an A-D scale) based on research evidence but a low rating (44%) based on clinical expertise. NSAIDs were rated highly with respect both to research evidence of efficacy (A) and to clinical expertise (80%).
“It's clear now that NSAIDs might have a controversial toxicity,” said Dr. Dougados in an interview. “But these drugs are very powerful and very efficient. I think prescriptions will continue but with more emphasis on decreasing dose and duration.”
We [need to] answer the question of when exactly to recommend and perform THR.
Lessons From an Older Biologic 'Reassuring'
BIRMINGHAM, ENGLAND — Long-term follow-up of a cohort of patients with rheumatoid arthritis who were treated with a lymphocytotoxic monoclonal antibody during the early 1990s offers reassuring support for the safety of current lymphocyte-depleting agents such as rituximab, John D. Isaacs, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
The first humanized monoclonal antibody, alemtuzumab (Campath-1H), was given to 53 patients with severe rheumatoid arthritis (RA) in the United Kingdom between 1991 and 1994.
Campath—so named because it was developed at the Cambridge University pathology laboratory—depleted both B and T cells, rendering patients profoundly lymphopenic, according to Dr. Isaacs.
This monoclonal antibody, alemtuzumab, recognizes CD52, which is present on the surface of many lymphocytes and on natural killer cells and macrophages.
“Our rationale for giving Campath to patients in the early 1990s, before [anti-tumor necrosis factor-α therapy became available, was that it would deplete the autoreactive immune system and that when reconstitution occurred the immune system would be healthy,” said Dr. Isaacs, professor of clinical rheumatology, School of Clinical Medical Sciences, University of Newcastle Upon Tyne (England).
The patients treated with Campath had severe, long-standing disease, with a median duration of 9 years. All had failed multiple disease-modifying drugs. Following one or more short courses of treatment with Campath, there was “dramatic” clinical improvement that in some cases was long lasting.
“But what we were not expecting was the lymphopenia, which ended up being quite prolonged,” he said.
During the first year after treatment, the CD4 counts were very low, and they slowly rose during the subsequent 5 years, but the levels never returned to normal. B-cell depletion was not as persistent.
In an earlier follow-up report on this group, Dr. Isaacs and his colleagues noted that 73–84 months after treatment the median CD4 count was 185 cells/μL, the median CD8 count was 95 cells/μL, and the median B-cell count was 115 cells/μL (Arthritis Rheum. 2001;44:1998–2008). This represents severe immunosuppression; the Centers for Disease Control and Prevention considers a CD4 count lower than 200 cells/μL in an HIV-positive patient a signal of AIDS.
These patients have now been followed for a mean of 12 years in a retrospective case-control study, in which outcomes for each patient were compared with two matched controls from the European League Against Rheumatism database of patients who received conventional immunosuppressive therapies such as azathioprine and cyclophosphamide.
Total follow-up is now roughly 464 patient-years.
There has been no significant difference in mortality between the two groups, with 20 deaths among the Campath cases and 37 among the controls.
Mortality also did not differ according to total dose of the monoclonal antibody or the number of courses received.
“The causes of death were primarily the complications we now associate with RA itself—vascular events and infections—and with the notable exception of one case of non-Hodgkin's lymphoma there were no infections or malignancies that one would normally associate with immunosuppression,” Dr. Isaacs said.
Despite the availability of successful therapies such as the TNF-α blockers and the fact that Campath is little used today, there still is a need for lymphocyte-depleting agents, he said.
“In fact, some of us believe that therapeutic tolerance in autoimmune disease will only become possible against a background of lymphocyte depletion,” he added.
BIRMINGHAM, ENGLAND — Long-term follow-up of a cohort of patients with rheumatoid arthritis who were treated with a lymphocytotoxic monoclonal antibody during the early 1990s offers reassuring support for the safety of current lymphocyte-depleting agents such as rituximab, John D. Isaacs, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
The first humanized monoclonal antibody, alemtuzumab (Campath-1H), was given to 53 patients with severe rheumatoid arthritis (RA) in the United Kingdom between 1991 and 1994.
Campath—so named because it was developed at the Cambridge University pathology laboratory—depleted both B and T cells, rendering patients profoundly lymphopenic, according to Dr. Isaacs.
This monoclonal antibody, alemtuzumab, recognizes CD52, which is present on the surface of many lymphocytes and on natural killer cells and macrophages.
“Our rationale for giving Campath to patients in the early 1990s, before [anti-tumor necrosis factor-α therapy became available, was that it would deplete the autoreactive immune system and that when reconstitution occurred the immune system would be healthy,” said Dr. Isaacs, professor of clinical rheumatology, School of Clinical Medical Sciences, University of Newcastle Upon Tyne (England).
The patients treated with Campath had severe, long-standing disease, with a median duration of 9 years. All had failed multiple disease-modifying drugs. Following one or more short courses of treatment with Campath, there was “dramatic” clinical improvement that in some cases was long lasting.
“But what we were not expecting was the lymphopenia, which ended up being quite prolonged,” he said.
During the first year after treatment, the CD4 counts were very low, and they slowly rose during the subsequent 5 years, but the levels never returned to normal. B-cell depletion was not as persistent.
In an earlier follow-up report on this group, Dr. Isaacs and his colleagues noted that 73–84 months after treatment the median CD4 count was 185 cells/μL, the median CD8 count was 95 cells/μL, and the median B-cell count was 115 cells/μL (Arthritis Rheum. 2001;44:1998–2008). This represents severe immunosuppression; the Centers for Disease Control and Prevention considers a CD4 count lower than 200 cells/μL in an HIV-positive patient a signal of AIDS.
These patients have now been followed for a mean of 12 years in a retrospective case-control study, in which outcomes for each patient were compared with two matched controls from the European League Against Rheumatism database of patients who received conventional immunosuppressive therapies such as azathioprine and cyclophosphamide.
Total follow-up is now roughly 464 patient-years.
There has been no significant difference in mortality between the two groups, with 20 deaths among the Campath cases and 37 among the controls.
Mortality also did not differ according to total dose of the monoclonal antibody or the number of courses received.
“The causes of death were primarily the complications we now associate with RA itself—vascular events and infections—and with the notable exception of one case of non-Hodgkin's lymphoma there were no infections or malignancies that one would normally associate with immunosuppression,” Dr. Isaacs said.
Despite the availability of successful therapies such as the TNF-α blockers and the fact that Campath is little used today, there still is a need for lymphocyte-depleting agents, he said.
“In fact, some of us believe that therapeutic tolerance in autoimmune disease will only become possible against a background of lymphocyte depletion,” he added.
BIRMINGHAM, ENGLAND — Long-term follow-up of a cohort of patients with rheumatoid arthritis who were treated with a lymphocytotoxic monoclonal antibody during the early 1990s offers reassuring support for the safety of current lymphocyte-depleting agents such as rituximab, John D. Isaacs, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
The first humanized monoclonal antibody, alemtuzumab (Campath-1H), was given to 53 patients with severe rheumatoid arthritis (RA) in the United Kingdom between 1991 and 1994.
Campath—so named because it was developed at the Cambridge University pathology laboratory—depleted both B and T cells, rendering patients profoundly lymphopenic, according to Dr. Isaacs.
This monoclonal antibody, alemtuzumab, recognizes CD52, which is present on the surface of many lymphocytes and on natural killer cells and macrophages.
“Our rationale for giving Campath to patients in the early 1990s, before [anti-tumor necrosis factor-α therapy became available, was that it would deplete the autoreactive immune system and that when reconstitution occurred the immune system would be healthy,” said Dr. Isaacs, professor of clinical rheumatology, School of Clinical Medical Sciences, University of Newcastle Upon Tyne (England).
The patients treated with Campath had severe, long-standing disease, with a median duration of 9 years. All had failed multiple disease-modifying drugs. Following one or more short courses of treatment with Campath, there was “dramatic” clinical improvement that in some cases was long lasting.
“But what we were not expecting was the lymphopenia, which ended up being quite prolonged,” he said.
During the first year after treatment, the CD4 counts were very low, and they slowly rose during the subsequent 5 years, but the levels never returned to normal. B-cell depletion was not as persistent.
In an earlier follow-up report on this group, Dr. Isaacs and his colleagues noted that 73–84 months after treatment the median CD4 count was 185 cells/μL, the median CD8 count was 95 cells/μL, and the median B-cell count was 115 cells/μL (Arthritis Rheum. 2001;44:1998–2008). This represents severe immunosuppression; the Centers for Disease Control and Prevention considers a CD4 count lower than 200 cells/μL in an HIV-positive patient a signal of AIDS.
These patients have now been followed for a mean of 12 years in a retrospective case-control study, in which outcomes for each patient were compared with two matched controls from the European League Against Rheumatism database of patients who received conventional immunosuppressive therapies such as azathioprine and cyclophosphamide.
Total follow-up is now roughly 464 patient-years.
There has been no significant difference in mortality between the two groups, with 20 deaths among the Campath cases and 37 among the controls.
Mortality also did not differ according to total dose of the monoclonal antibody or the number of courses received.
“The causes of death were primarily the complications we now associate with RA itself—vascular events and infections—and with the notable exception of one case of non-Hodgkin's lymphoma there were no infections or malignancies that one would normally associate with immunosuppression,” Dr. Isaacs said.
Despite the availability of successful therapies such as the TNF-α blockers and the fact that Campath is little used today, there still is a need for lymphocyte-depleting agents, he said.
“In fact, some of us believe that therapeutic tolerance in autoimmune disease will only become possible against a background of lymphocyte depletion,” he added.
Adalimumab Shows Promise for Refractory Psoriatic Arthritis
NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.
“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”
Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.
All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.
At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.
Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.
This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.
Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.
Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).
Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.
The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.
Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.
Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.
All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.
NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.
“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”
Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.
All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.
At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.
Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.
This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.
Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.
Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).
Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.
The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.
Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.
Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.
All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.
NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.
“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”
Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.
All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.
At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.
Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.
This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.
Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.
Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).
Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.
The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.
Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.
Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.
All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.
Multiple Joint Involvement Shown As the Rule, Not the Exception
VIENNA — Multiple joint problems are the rule, not the exception, in individuals with joint pathology, Anne-Maree Keenan reported at the annual European congress of rheumatology.
She presented the results of a very large British primary care practice survey showing that the prevalence of one or more chronic joint problems was high in individuals older than 55 years—and that the median number of such problems in affected individuals was four.
Moreover, the degree of associated functional impairment in activities of daily living rose exponentially rather than additively as the number of joint problems increased, said Ms. Keenan, a podiatrist and research fellow in the academic unit of musculoskeletal disease and rehabilitation, University of Leeds, England.
These findings highlight the drawbacks of the typical assessment and treatment algorithms for joint pathology. Busy physicians often focus on a single major joint, thereby ignoring the true extent of the patient's problems.
“What we've found in interviewing people is that because they have such a short time in the physician's office, their knee problem is all they'll talk about, when in fact they have problems with other joints that go unaddressed,” she told this newspaper at the meeting, which was sponsored by the European League Against Rheumatism.
Ms. Keenan reported on 16,222 community-dwelling British adults older than 55 years who completed a postal questionnaire about joint problems.
The research, funded by the U.K. Arthritis Research Campaign, was conducted under the auspices of the Leeds West Primary Care Trust. The survey response rate was 86%.
Participants were asked to report joint problems involving pain, swelling, and/or stiffness that lasted more than 6 weeks during the prior 3 months, and to rate the effect on activities of daily living.
The knee was the joint most frequently involved, with a prevalence of 220 per 1,000 population. However, the knee was the sole joint involved in only 1 of 11 affected individuals.
Far more commonly, knee pathology was reported in combination with problems in the hands, feet, back, and other joints.
Individuals with single joint pathology restricted to the knee were 3.7-fold more likely than respondents without joint problems to report significant difficulty in standing and walking.
But individuals with multiple joint problems involving the knees and feet were 14.5-fold more likely to have difficulty in standing and walking. And in those with problems affecting the knee, back, feet, and hips—a condition with roughly the same prevalence as isolated knee pathology in the survey population—the odds of difficulty in standing and walking shot up to 39-fold greater than in individuals without joint problems.
VIENNA — Multiple joint problems are the rule, not the exception, in individuals with joint pathology, Anne-Maree Keenan reported at the annual European congress of rheumatology.
She presented the results of a very large British primary care practice survey showing that the prevalence of one or more chronic joint problems was high in individuals older than 55 years—and that the median number of such problems in affected individuals was four.
Moreover, the degree of associated functional impairment in activities of daily living rose exponentially rather than additively as the number of joint problems increased, said Ms. Keenan, a podiatrist and research fellow in the academic unit of musculoskeletal disease and rehabilitation, University of Leeds, England.
These findings highlight the drawbacks of the typical assessment and treatment algorithms for joint pathology. Busy physicians often focus on a single major joint, thereby ignoring the true extent of the patient's problems.
“What we've found in interviewing people is that because they have such a short time in the physician's office, their knee problem is all they'll talk about, when in fact they have problems with other joints that go unaddressed,” she told this newspaper at the meeting, which was sponsored by the European League Against Rheumatism.
Ms. Keenan reported on 16,222 community-dwelling British adults older than 55 years who completed a postal questionnaire about joint problems.
The research, funded by the U.K. Arthritis Research Campaign, was conducted under the auspices of the Leeds West Primary Care Trust. The survey response rate was 86%.
Participants were asked to report joint problems involving pain, swelling, and/or stiffness that lasted more than 6 weeks during the prior 3 months, and to rate the effect on activities of daily living.
The knee was the joint most frequently involved, with a prevalence of 220 per 1,000 population. However, the knee was the sole joint involved in only 1 of 11 affected individuals.
Far more commonly, knee pathology was reported in combination with problems in the hands, feet, back, and other joints.
Individuals with single joint pathology restricted to the knee were 3.7-fold more likely than respondents without joint problems to report significant difficulty in standing and walking.
But individuals with multiple joint problems involving the knees and feet were 14.5-fold more likely to have difficulty in standing and walking. And in those with problems affecting the knee, back, feet, and hips—a condition with roughly the same prevalence as isolated knee pathology in the survey population—the odds of difficulty in standing and walking shot up to 39-fold greater than in individuals without joint problems.
VIENNA — Multiple joint problems are the rule, not the exception, in individuals with joint pathology, Anne-Maree Keenan reported at the annual European congress of rheumatology.
She presented the results of a very large British primary care practice survey showing that the prevalence of one or more chronic joint problems was high in individuals older than 55 years—and that the median number of such problems in affected individuals was four.
Moreover, the degree of associated functional impairment in activities of daily living rose exponentially rather than additively as the number of joint problems increased, said Ms. Keenan, a podiatrist and research fellow in the academic unit of musculoskeletal disease and rehabilitation, University of Leeds, England.
These findings highlight the drawbacks of the typical assessment and treatment algorithms for joint pathology. Busy physicians often focus on a single major joint, thereby ignoring the true extent of the patient's problems.
“What we've found in interviewing people is that because they have such a short time in the physician's office, their knee problem is all they'll talk about, when in fact they have problems with other joints that go unaddressed,” she told this newspaper at the meeting, which was sponsored by the European League Against Rheumatism.
Ms. Keenan reported on 16,222 community-dwelling British adults older than 55 years who completed a postal questionnaire about joint problems.
The research, funded by the U.K. Arthritis Research Campaign, was conducted under the auspices of the Leeds West Primary Care Trust. The survey response rate was 86%.
Participants were asked to report joint problems involving pain, swelling, and/or stiffness that lasted more than 6 weeks during the prior 3 months, and to rate the effect on activities of daily living.
The knee was the joint most frequently involved, with a prevalence of 220 per 1,000 population. However, the knee was the sole joint involved in only 1 of 11 affected individuals.
Far more commonly, knee pathology was reported in combination with problems in the hands, feet, back, and other joints.
Individuals with single joint pathology restricted to the knee were 3.7-fold more likely than respondents without joint problems to report significant difficulty in standing and walking.
But individuals with multiple joint problems involving the knees and feet were 14.5-fold more likely to have difficulty in standing and walking. And in those with problems affecting the knee, back, feet, and hips—a condition with roughly the same prevalence as isolated knee pathology in the survey population—the odds of difficulty in standing and walking shot up to 39-fold greater than in individuals without joint problems.
Careful Dosing May Boost Response to Infliximab
Rheumatoid arthritis patients' response to treatment with infliximab may be improved by adjusting the dosage according to serum trough levels of infliximab, as well as to pretreatment levels of C-reactive protein, a study has indicated.
An open, prospective observational study of 105 consecutive patients with rheumatoid arthritis “confirms the relationship” between trough serum concentrations of infliximab and the extent of clinical improvement in patients taking the drug, reported G.J. Wolbink, M.D., of the Jan van Breemen Institute in Amsterdam, and associates.
The study also showed that levels of pretreatment C-reactive protein (CRP) correlate negatively with serum trough levels of infliximab and clinical response, they said.
“As infliximab is expensive, it might be efficient to adjust the infliximab dosing schedule after measurement of the serum infliximab concentration,” the investigators said.
In addition, “patients with high pretreatment CRP levels might benefit from higher dosages of infliximab than patients with low CRP levels,” they said (Ann. Rheum. Dis. 2005;64:704–7).
The investigators measured serum trough infliximab levels before intravenous infusions of 3 mg/kg infliximab, a TNF blocking treatment, at 0, 2, 6, and 14 weeks.
They assessed disease activity before each infusion using the 28-joint count Disease Activity Score (DAS28). In addition, they used European League Against Rheumatism response criteria to classify patients at 14 weeks as “responders” or “nonresponders,” and they categorized patients into three groups according to their infliximab levels.
(Nonresponse was defined as a DAS28 decrease after 14 weeks of 0.6 or less, or a decrease between 0.6 and 1.2 with an attained DAS of greater than 5.1).
At 14 weeks, nonresponders had significantly lower median serum trough infliximab concentrations than responders (0.5 vs. 3.6 mg/L). The association remained significant after correction for potential confounders such as baseline CPR, baseline DAS28 score, and rheumatoid factor.
Moreover, patients categorized as having low infliximab levels at 14 weeks less often fulfilled the EULAR response criteria than patients with intermediate and high infliximab levels (50% vs. 90% and 88%). They also had significantly less improvement in the DAS28 score (−0.9 vs. −2.0 and −2.4).
Pretreatment levels of CRP—used as an indirect marker for TNF production—correlated negatively with infliximab levels at each dosage interval.
And during the last treatment interval (6–14 weeks) the change in the DAS28 score of patients with low pretreatment CRP levels differed significantly from that of patients with high pretreatment CRP levels (−0.2 vs. 0.6), the investigators reported.
The majority of patients were women (82%) with a mean disease duration of 12 years and a mean DAS28 score at entry of 6.1. Most had used methotrexate, and this as well as other stable drug treatments were continued during the study.
Rheumatoid arthritis patients' response to treatment with infliximab may be improved by adjusting the dosage according to serum trough levels of infliximab, as well as to pretreatment levels of C-reactive protein, a study has indicated.
An open, prospective observational study of 105 consecutive patients with rheumatoid arthritis “confirms the relationship” between trough serum concentrations of infliximab and the extent of clinical improvement in patients taking the drug, reported G.J. Wolbink, M.D., of the Jan van Breemen Institute in Amsterdam, and associates.
The study also showed that levels of pretreatment C-reactive protein (CRP) correlate negatively with serum trough levels of infliximab and clinical response, they said.
“As infliximab is expensive, it might be efficient to adjust the infliximab dosing schedule after measurement of the serum infliximab concentration,” the investigators said.
In addition, “patients with high pretreatment CRP levels might benefit from higher dosages of infliximab than patients with low CRP levels,” they said (Ann. Rheum. Dis. 2005;64:704–7).
The investigators measured serum trough infliximab levels before intravenous infusions of 3 mg/kg infliximab, a TNF blocking treatment, at 0, 2, 6, and 14 weeks.
They assessed disease activity before each infusion using the 28-joint count Disease Activity Score (DAS28). In addition, they used European League Against Rheumatism response criteria to classify patients at 14 weeks as “responders” or “nonresponders,” and they categorized patients into three groups according to their infliximab levels.
(Nonresponse was defined as a DAS28 decrease after 14 weeks of 0.6 or less, or a decrease between 0.6 and 1.2 with an attained DAS of greater than 5.1).
At 14 weeks, nonresponders had significantly lower median serum trough infliximab concentrations than responders (0.5 vs. 3.6 mg/L). The association remained significant after correction for potential confounders such as baseline CPR, baseline DAS28 score, and rheumatoid factor.
Moreover, patients categorized as having low infliximab levels at 14 weeks less often fulfilled the EULAR response criteria than patients with intermediate and high infliximab levels (50% vs. 90% and 88%). They also had significantly less improvement in the DAS28 score (−0.9 vs. −2.0 and −2.4).
Pretreatment levels of CRP—used as an indirect marker for TNF production—correlated negatively with infliximab levels at each dosage interval.
And during the last treatment interval (6–14 weeks) the change in the DAS28 score of patients with low pretreatment CRP levels differed significantly from that of patients with high pretreatment CRP levels (−0.2 vs. 0.6), the investigators reported.
The majority of patients were women (82%) with a mean disease duration of 12 years and a mean DAS28 score at entry of 6.1. Most had used methotrexate, and this as well as other stable drug treatments were continued during the study.
Rheumatoid arthritis patients' response to treatment with infliximab may be improved by adjusting the dosage according to serum trough levels of infliximab, as well as to pretreatment levels of C-reactive protein, a study has indicated.
An open, prospective observational study of 105 consecutive patients with rheumatoid arthritis “confirms the relationship” between trough serum concentrations of infliximab and the extent of clinical improvement in patients taking the drug, reported G.J. Wolbink, M.D., of the Jan van Breemen Institute in Amsterdam, and associates.
The study also showed that levels of pretreatment C-reactive protein (CRP) correlate negatively with serum trough levels of infliximab and clinical response, they said.
“As infliximab is expensive, it might be efficient to adjust the infliximab dosing schedule after measurement of the serum infliximab concentration,” the investigators said.
In addition, “patients with high pretreatment CRP levels might benefit from higher dosages of infliximab than patients with low CRP levels,” they said (Ann. Rheum. Dis. 2005;64:704–7).
The investigators measured serum trough infliximab levels before intravenous infusions of 3 mg/kg infliximab, a TNF blocking treatment, at 0, 2, 6, and 14 weeks.
They assessed disease activity before each infusion using the 28-joint count Disease Activity Score (DAS28). In addition, they used European League Against Rheumatism response criteria to classify patients at 14 weeks as “responders” or “nonresponders,” and they categorized patients into three groups according to their infliximab levels.
(Nonresponse was defined as a DAS28 decrease after 14 weeks of 0.6 or less, or a decrease between 0.6 and 1.2 with an attained DAS of greater than 5.1).
At 14 weeks, nonresponders had significantly lower median serum trough infliximab concentrations than responders (0.5 vs. 3.6 mg/L). The association remained significant after correction for potential confounders such as baseline CPR, baseline DAS28 score, and rheumatoid factor.
Moreover, patients categorized as having low infliximab levels at 14 weeks less often fulfilled the EULAR response criteria than patients with intermediate and high infliximab levels (50% vs. 90% and 88%). They also had significantly less improvement in the DAS28 score (−0.9 vs. −2.0 and −2.4).
Pretreatment levels of CRP—used as an indirect marker for TNF production—correlated negatively with infliximab levels at each dosage interval.
And during the last treatment interval (6–14 weeks) the change in the DAS28 score of patients with low pretreatment CRP levels differed significantly from that of patients with high pretreatment CRP levels (−0.2 vs. 0.6), the investigators reported.
The majority of patients were women (82%) with a mean disease duration of 12 years and a mean DAS28 score at entry of 6.1. Most had used methotrexate, and this as well as other stable drug treatments were continued during the study.
Serious Infection Rates Similar Among Biologics
BIRMINGHAM, ENGLAND — No important differences in rates of serious infections have been reported among patients treated with etanercept, infliximab, or adalimumab, according to a report from the British Society for Rheumatology Biologics Register (BSRBR).
Since January 2002 all patients in the United Kingdom with rheumatic diseases who are treated with biologic agents have been enrolled in the register. They are being followed with the goal of determining the incidence and nature of any short- or long-term adverse effects, Will Dixon, Ph.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
To date, data have been analyzed for 2,602 patients who have received etanercept, 2,871 treated with infliximab, and 915 given adalimumab with follow-up for at least 6 months, he said.
Patients in the three groups had similar demographics: The mean age in all groups was 54 years, and median disease duration was 12 years. Three-quarters were women.
Thus far, there have been 132 serious infections among patients on etanercept, 205 in those on infliximab, and 40 in those on adalimumab.
Incidence rates for the three groups were 52.6, 52.1, and 62.4 per 1,000 patient years, respectively. The differences in incidence rates were not statistically significant, said Dr. Dixon of the BSRBR Arthritis Research Campaign epidemiology unit at the University of Manchester (England).
Serious infections were defined as those requiring intravenous antibiotics, leading to a hospital admission, or being in any way life threatening, he said. The most common sites of serious infections also were broadly similar (see the chart).
All three drugs are inhibitors of tumor necrosis factor (TNF)-α, which is a cytokine with a central role in the inflammatory process of rheumatoid arthritis, Dr. Dixon explained. However, it also has a role in infection control, acting synergistically with interferon-γ. In its anti-infection capacity, TNF-α is particularly crucial for the control of intracellular infections such as tuberculosis, where its inhibition can lead to dissemination of the infection.
With regard to these types of infection, there have been 11 cases of tuberculosis, 9 in patients on infliximab and 2 in patients on etanercept; incidence rates for tuberculosis were 2.3 and 0.8 per 1,000 patient-years for the two drugs, respectively. Despite the fact that the rate was more than 2.5-fold higher with infliximab, the difference was not statistically significant because of the small numbers, he said.
There were two cases of Salmonella septic arthritis and one of Salmonella gastroenteritis, all in patients receiving etanercept, Dr. Dixon said. One case of Legionella pneumonia was reported following treatment with infliximab.
When an audience member asked if concurrent steroid therapy might be a contributing factor to the development of infection, Dr. Dixon replied that the strongest predictor of infection was diabetes, followed by a high Health Assessment Questionnaire score, and then steroid use. About 50% of patients were on steroids at baseline.
BIRMINGHAM, ENGLAND — No important differences in rates of serious infections have been reported among patients treated with etanercept, infliximab, or adalimumab, according to a report from the British Society for Rheumatology Biologics Register (BSRBR).
Since January 2002 all patients in the United Kingdom with rheumatic diseases who are treated with biologic agents have been enrolled in the register. They are being followed with the goal of determining the incidence and nature of any short- or long-term adverse effects, Will Dixon, Ph.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
To date, data have been analyzed for 2,602 patients who have received etanercept, 2,871 treated with infliximab, and 915 given adalimumab with follow-up for at least 6 months, he said.
Patients in the three groups had similar demographics: The mean age in all groups was 54 years, and median disease duration was 12 years. Three-quarters were women.
Thus far, there have been 132 serious infections among patients on etanercept, 205 in those on infliximab, and 40 in those on adalimumab.
Incidence rates for the three groups were 52.6, 52.1, and 62.4 per 1,000 patient years, respectively. The differences in incidence rates were not statistically significant, said Dr. Dixon of the BSRBR Arthritis Research Campaign epidemiology unit at the University of Manchester (England).
Serious infections were defined as those requiring intravenous antibiotics, leading to a hospital admission, or being in any way life threatening, he said. The most common sites of serious infections also were broadly similar (see the chart).
All three drugs are inhibitors of tumor necrosis factor (TNF)-α, which is a cytokine with a central role in the inflammatory process of rheumatoid arthritis, Dr. Dixon explained. However, it also has a role in infection control, acting synergistically with interferon-γ. In its anti-infection capacity, TNF-α is particularly crucial for the control of intracellular infections such as tuberculosis, where its inhibition can lead to dissemination of the infection.
With regard to these types of infection, there have been 11 cases of tuberculosis, 9 in patients on infliximab and 2 in patients on etanercept; incidence rates for tuberculosis were 2.3 and 0.8 per 1,000 patient-years for the two drugs, respectively. Despite the fact that the rate was more than 2.5-fold higher with infliximab, the difference was not statistically significant because of the small numbers, he said.
There were two cases of Salmonella septic arthritis and one of Salmonella gastroenteritis, all in patients receiving etanercept, Dr. Dixon said. One case of Legionella pneumonia was reported following treatment with infliximab.
When an audience member asked if concurrent steroid therapy might be a contributing factor to the development of infection, Dr. Dixon replied that the strongest predictor of infection was diabetes, followed by a high Health Assessment Questionnaire score, and then steroid use. About 50% of patients were on steroids at baseline.
BIRMINGHAM, ENGLAND — No important differences in rates of serious infections have been reported among patients treated with etanercept, infliximab, or adalimumab, according to a report from the British Society for Rheumatology Biologics Register (BSRBR).
Since January 2002 all patients in the United Kingdom with rheumatic diseases who are treated with biologic agents have been enrolled in the register. They are being followed with the goal of determining the incidence and nature of any short- or long-term adverse effects, Will Dixon, Ph.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.
To date, data have been analyzed for 2,602 patients who have received etanercept, 2,871 treated with infliximab, and 915 given adalimumab with follow-up for at least 6 months, he said.
Patients in the three groups had similar demographics: The mean age in all groups was 54 years, and median disease duration was 12 years. Three-quarters were women.
Thus far, there have been 132 serious infections among patients on etanercept, 205 in those on infliximab, and 40 in those on adalimumab.
Incidence rates for the three groups were 52.6, 52.1, and 62.4 per 1,000 patient years, respectively. The differences in incidence rates were not statistically significant, said Dr. Dixon of the BSRBR Arthritis Research Campaign epidemiology unit at the University of Manchester (England).
Serious infections were defined as those requiring intravenous antibiotics, leading to a hospital admission, or being in any way life threatening, he said. The most common sites of serious infections also were broadly similar (see the chart).
All three drugs are inhibitors of tumor necrosis factor (TNF)-α, which is a cytokine with a central role in the inflammatory process of rheumatoid arthritis, Dr. Dixon explained. However, it also has a role in infection control, acting synergistically with interferon-γ. In its anti-infection capacity, TNF-α is particularly crucial for the control of intracellular infections such as tuberculosis, where its inhibition can lead to dissemination of the infection.
With regard to these types of infection, there have been 11 cases of tuberculosis, 9 in patients on infliximab and 2 in patients on etanercept; incidence rates for tuberculosis were 2.3 and 0.8 per 1,000 patient-years for the two drugs, respectively. Despite the fact that the rate was more than 2.5-fold higher with infliximab, the difference was not statistically significant because of the small numbers, he said.
There were two cases of Salmonella septic arthritis and one of Salmonella gastroenteritis, all in patients receiving etanercept, Dr. Dixon said. One case of Legionella pneumonia was reported following treatment with infliximab.
When an audience member asked if concurrent steroid therapy might be a contributing factor to the development of infection, Dr. Dixon replied that the strongest predictor of infection was diabetes, followed by a high Health Assessment Questionnaire score, and then steroid use. About 50% of patients were on steroids at baseline.
Ankylosing Spondylitis: Risk for Renal Stones
CHICAGO — Renal stones are more prevalent in ankylosing spondylitis patients than in those with rheumatoid arthritis, according to the results of a preliminary study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.
The investigation, led by Susan A. Leonard, M.D., of the University of Minnesota, Minneapolis, was the first to describe an association between nephrolithiasis and spondyloarthritis since a Croatian study that was published more than 30 years ago (Reumatizam 1973;20:106–10), according to Hollis E. Krug, M.D., who presented the latest data in a poster session at the meeting.
In their retrospective cohort study of 44 patients with spondyloarthritis and 51 controls with RA undergoing treatment at the Minneapolis Veterans Affairs Medical Center, the Minnesota-based researchers found a statistically significant greater prevalence of renal calculi in patients with ankylosing spondylitis compared with those with RA (38.6% versus 15.7%).
“There didn't seem to be a higher rate of coexistent disease in spondyloarthritis patients that could increase the risk for renal stones,” Dr. Krug said. However, medication use at diagnosis of nephrolithiasis was not documented in the patients' charts, and that may have played a role in formation of kidney stones, she told this newspaper.
The Minneapolis group plans to study more patients in an attempt to explain the reason for this association.
CHICAGO — Renal stones are more prevalent in ankylosing spondylitis patients than in those with rheumatoid arthritis, according to the results of a preliminary study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.
The investigation, led by Susan A. Leonard, M.D., of the University of Minnesota, Minneapolis, was the first to describe an association between nephrolithiasis and spondyloarthritis since a Croatian study that was published more than 30 years ago (Reumatizam 1973;20:106–10), according to Hollis E. Krug, M.D., who presented the latest data in a poster session at the meeting.
In their retrospective cohort study of 44 patients with spondyloarthritis and 51 controls with RA undergoing treatment at the Minneapolis Veterans Affairs Medical Center, the Minnesota-based researchers found a statistically significant greater prevalence of renal calculi in patients with ankylosing spondylitis compared with those with RA (38.6% versus 15.7%).
“There didn't seem to be a higher rate of coexistent disease in spondyloarthritis patients that could increase the risk for renal stones,” Dr. Krug said. However, medication use at diagnosis of nephrolithiasis was not documented in the patients' charts, and that may have played a role in formation of kidney stones, she told this newspaper.
The Minneapolis group plans to study more patients in an attempt to explain the reason for this association.
CHICAGO — Renal stones are more prevalent in ankylosing spondylitis patients than in those with rheumatoid arthritis, according to the results of a preliminary study presented at the combined annual meeting of the Central Society for Clinical Research and the Midwestern section of the American Federation for Medical Research.
The investigation, led by Susan A. Leonard, M.D., of the University of Minnesota, Minneapolis, was the first to describe an association between nephrolithiasis and spondyloarthritis since a Croatian study that was published more than 30 years ago (Reumatizam 1973;20:106–10), according to Hollis E. Krug, M.D., who presented the latest data in a poster session at the meeting.
In their retrospective cohort study of 44 patients with spondyloarthritis and 51 controls with RA undergoing treatment at the Minneapolis Veterans Affairs Medical Center, the Minnesota-based researchers found a statistically significant greater prevalence of renal calculi in patients with ankylosing spondylitis compared with those with RA (38.6% versus 15.7%).
“There didn't seem to be a higher rate of coexistent disease in spondyloarthritis patients that could increase the risk for renal stones,” Dr. Krug said. However, medication use at diagnosis of nephrolithiasis was not documented in the patients' charts, and that may have played a role in formation of kidney stones, she told this newspaper.
The Minneapolis group plans to study more patients in an attempt to explain the reason for this association.