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Strong Link Between Gout, Metabolic Syndrome Found
The prevalence of metabolic syndrome may be nearly three times higher among individuals with gout, compared with unaffected individuals, judging from results of a recent data analysis.
A link between gout and metabolic syndrome has been suggested by other investigators, but the degree of the overlap between the two conditions has remained unclear, according to study investigators Dr. Hyon K. Choi of the Arthritis Research Centre of Canada and his associates.
A total of 8,807 individuals aged 20 years or older participated in the third National Health and Nutrition Examination Survey (NHANES-III) from 1988 to 1994. A total of 233 had gout, according to self-report (mean age of 58 years). All individuals were assessed for metabolic syndrome; the condition was deemed to be present if an individual had at least three of the following five metabolic abnormalities: abdominal obesity, hypertriglyceridemia, low HDL cholesterol, high blood pressure, and high fasting glucose.
Prevalence of metabolic syndrome was approximately 63% among the 233 individuals with gout and 25% among 8,574 individuals without gout. The prevalence rates of each of the five metabolic abnormalities associated with metabolic syndrome were higher among adults with gout. The prevalence of high blood pressure in individuals with gout (69%) was more than double the prevalence of those without. The link between metabolic abnormalities and gout was evident across subgroups of major associated gout risk factors including body mass index, hypertension, and diabetes, the investigators reported (Arthritis Rheum. 2007;57:109–15).
The interplay between hyperuricemia and high insulin levels caused by insulin resistance may explain the connection. Prevalence of hyperuricemia was 49% among individuals with gout and 18% among those without, according to the analysis by Dr. Choi and his associates.
Prevalence of metabolic syndrome increased from 27% among participants with gout aged 20–39 years to 72% among participants aged 40–59. Prevalence of metabolic syndrome among individuals without gout increased from only 12% in adults aged 20–39 years to 31% in those aged 40–59 years Prevalence for metabolic syndrome in adults over age 60 years with gout (71%) was more substantial than in those without gout (49%).
The study was funded by TAP Pharmaceutical Products Inc. and Savient Pharmaceuticals Inc. Dr. Choi reported receiving consulting fees from both companies.
The prevalence of metabolic syndrome may be nearly three times higher among individuals with gout, compared with unaffected individuals, judging from results of a recent data analysis.
A link between gout and metabolic syndrome has been suggested by other investigators, but the degree of the overlap between the two conditions has remained unclear, according to study investigators Dr. Hyon K. Choi of the Arthritis Research Centre of Canada and his associates.
A total of 8,807 individuals aged 20 years or older participated in the third National Health and Nutrition Examination Survey (NHANES-III) from 1988 to 1994. A total of 233 had gout, according to self-report (mean age of 58 years). All individuals were assessed for metabolic syndrome; the condition was deemed to be present if an individual had at least three of the following five metabolic abnormalities: abdominal obesity, hypertriglyceridemia, low HDL cholesterol, high blood pressure, and high fasting glucose.
Prevalence of metabolic syndrome was approximately 63% among the 233 individuals with gout and 25% among 8,574 individuals without gout. The prevalence rates of each of the five metabolic abnormalities associated with metabolic syndrome were higher among adults with gout. The prevalence of high blood pressure in individuals with gout (69%) was more than double the prevalence of those without. The link between metabolic abnormalities and gout was evident across subgroups of major associated gout risk factors including body mass index, hypertension, and diabetes, the investigators reported (Arthritis Rheum. 2007;57:109–15).
The interplay between hyperuricemia and high insulin levels caused by insulin resistance may explain the connection. Prevalence of hyperuricemia was 49% among individuals with gout and 18% among those without, according to the analysis by Dr. Choi and his associates.
Prevalence of metabolic syndrome increased from 27% among participants with gout aged 20–39 years to 72% among participants aged 40–59. Prevalence of metabolic syndrome among individuals without gout increased from only 12% in adults aged 20–39 years to 31% in those aged 40–59 years Prevalence for metabolic syndrome in adults over age 60 years with gout (71%) was more substantial than in those without gout (49%).
The study was funded by TAP Pharmaceutical Products Inc. and Savient Pharmaceuticals Inc. Dr. Choi reported receiving consulting fees from both companies.
The prevalence of metabolic syndrome may be nearly three times higher among individuals with gout, compared with unaffected individuals, judging from results of a recent data analysis.
A link between gout and metabolic syndrome has been suggested by other investigators, but the degree of the overlap between the two conditions has remained unclear, according to study investigators Dr. Hyon K. Choi of the Arthritis Research Centre of Canada and his associates.
A total of 8,807 individuals aged 20 years or older participated in the third National Health and Nutrition Examination Survey (NHANES-III) from 1988 to 1994. A total of 233 had gout, according to self-report (mean age of 58 years). All individuals were assessed for metabolic syndrome; the condition was deemed to be present if an individual had at least three of the following five metabolic abnormalities: abdominal obesity, hypertriglyceridemia, low HDL cholesterol, high blood pressure, and high fasting glucose.
Prevalence of metabolic syndrome was approximately 63% among the 233 individuals with gout and 25% among 8,574 individuals without gout. The prevalence rates of each of the five metabolic abnormalities associated with metabolic syndrome were higher among adults with gout. The prevalence of high blood pressure in individuals with gout (69%) was more than double the prevalence of those without. The link between metabolic abnormalities and gout was evident across subgroups of major associated gout risk factors including body mass index, hypertension, and diabetes, the investigators reported (Arthritis Rheum. 2007;57:109–15).
The interplay between hyperuricemia and high insulin levels caused by insulin resistance may explain the connection. Prevalence of hyperuricemia was 49% among individuals with gout and 18% among those without, according to the analysis by Dr. Choi and his associates.
Prevalence of metabolic syndrome increased from 27% among participants with gout aged 20–39 years to 72% among participants aged 40–59. Prevalence of metabolic syndrome among individuals without gout increased from only 12% in adults aged 20–39 years to 31% in those aged 40–59 years Prevalence for metabolic syndrome in adults over age 60 years with gout (71%) was more substantial than in those without gout (49%).
The study was funded by TAP Pharmaceutical Products Inc. and Savient Pharmaceuticals Inc. Dr. Choi reported receiving consulting fees from both companies.
DMARDs Ineffective for Recent-Onset RA After Initial Methotrexate Failure
Individuals with recent-onset rheumatoid arthritis treated according to disease activity score for 2 years appear to gain little benefit from conventional disease-modifying antirheumatic drugs after initial methotrexate failure, according to the results of a post hoc analysis of the randomized, multicenter, controlled BeSt study.
Overall, 162 of the 244 study patients (66%) failed 2 years of initial methotrexate (MTX) therapy. A subsequent addition of, or switch to, sulfasalazine (SSA), failed in 108 of 138 patients (78%). Subsequent leflunomide monotherapy failed in 47 of 54 patients (87%), while MTX plus SSA and hydroxychloroquine failed in 28 of 44 patients (64%), reported Dr. Sjoerd M. van der Kooij of the Leiden (the Netherlands) University Medical Center and colleagues. However, 34 of 48 patients (71%) who switched to MTX plus infliximab did have treatment success.
Overall, the median total Sharp/van der Heijde score progression was significantly greater among “MTX failures” than “MTX successes” (3 units vs. 1 unit, respectively), regardless of response to subsequent disease-modifying antirheumatic drugs (DMARDs) (Ann. Rheum. Dis. 2007 Feb. 9 [Epub doi:10.1136/ard.2006.066662]).
“This observation confirms earlier studies suggesting that adequate, early suppression of disease activity is paramount for the suppression of joint damage progression,” wrote Dr. van der Kooij and colleagues.
“MTX successes” included the 79 patients who achieved a disease activity score (DAS) of 2.4 after 2 years of methotrexate monotherapy. “MTX failures” included the 66% of patients in the study who initially received MTX 15–25 mg/wk but who discontinued the drug because of toxicity or failure to achieve a DAS of 2.4 or less after 2 years, according to the investigators. These patients were then randomized to receive either sequential monotherapy or a step-up combination therapy. A higher DAS at baseline and female sex were significantly and independently predictive of MTX failure.
Dr. van der Kooij and colleagues suggested that, following the failure of initial MTX therapy, treatment with an anti-tumor necrosis factor agent should not be delayed, given that “switching to or adding other conventional DMARDs offers little chance of clinical efficacy and allows progression of joint damage.”
BeST is supported by the Dutch government and the Dutch College of Health Insurance Companies.
Individuals with recent-onset rheumatoid arthritis treated according to disease activity score for 2 years appear to gain little benefit from conventional disease-modifying antirheumatic drugs after initial methotrexate failure, according to the results of a post hoc analysis of the randomized, multicenter, controlled BeSt study.
Overall, 162 of the 244 study patients (66%) failed 2 years of initial methotrexate (MTX) therapy. A subsequent addition of, or switch to, sulfasalazine (SSA), failed in 108 of 138 patients (78%). Subsequent leflunomide monotherapy failed in 47 of 54 patients (87%), while MTX plus SSA and hydroxychloroquine failed in 28 of 44 patients (64%), reported Dr. Sjoerd M. van der Kooij of the Leiden (the Netherlands) University Medical Center and colleagues. However, 34 of 48 patients (71%) who switched to MTX plus infliximab did have treatment success.
Overall, the median total Sharp/van der Heijde score progression was significantly greater among “MTX failures” than “MTX successes” (3 units vs. 1 unit, respectively), regardless of response to subsequent disease-modifying antirheumatic drugs (DMARDs) (Ann. Rheum. Dis. 2007 Feb. 9 [Epub doi:10.1136/ard.2006.066662]).
“This observation confirms earlier studies suggesting that adequate, early suppression of disease activity is paramount for the suppression of joint damage progression,” wrote Dr. van der Kooij and colleagues.
“MTX successes” included the 79 patients who achieved a disease activity score (DAS) of 2.4 after 2 years of methotrexate monotherapy. “MTX failures” included the 66% of patients in the study who initially received MTX 15–25 mg/wk but who discontinued the drug because of toxicity or failure to achieve a DAS of 2.4 or less after 2 years, according to the investigators. These patients were then randomized to receive either sequential monotherapy or a step-up combination therapy. A higher DAS at baseline and female sex were significantly and independently predictive of MTX failure.
Dr. van der Kooij and colleagues suggested that, following the failure of initial MTX therapy, treatment with an anti-tumor necrosis factor agent should not be delayed, given that “switching to or adding other conventional DMARDs offers little chance of clinical efficacy and allows progression of joint damage.”
BeST is supported by the Dutch government and the Dutch College of Health Insurance Companies.
Individuals with recent-onset rheumatoid arthritis treated according to disease activity score for 2 years appear to gain little benefit from conventional disease-modifying antirheumatic drugs after initial methotrexate failure, according to the results of a post hoc analysis of the randomized, multicenter, controlled BeSt study.
Overall, 162 of the 244 study patients (66%) failed 2 years of initial methotrexate (MTX) therapy. A subsequent addition of, or switch to, sulfasalazine (SSA), failed in 108 of 138 patients (78%). Subsequent leflunomide monotherapy failed in 47 of 54 patients (87%), while MTX plus SSA and hydroxychloroquine failed in 28 of 44 patients (64%), reported Dr. Sjoerd M. van der Kooij of the Leiden (the Netherlands) University Medical Center and colleagues. However, 34 of 48 patients (71%) who switched to MTX plus infliximab did have treatment success.
Overall, the median total Sharp/van der Heijde score progression was significantly greater among “MTX failures” than “MTX successes” (3 units vs. 1 unit, respectively), regardless of response to subsequent disease-modifying antirheumatic drugs (DMARDs) (Ann. Rheum. Dis. 2007 Feb. 9 [Epub doi:10.1136/ard.2006.066662]).
“This observation confirms earlier studies suggesting that adequate, early suppression of disease activity is paramount for the suppression of joint damage progression,” wrote Dr. van der Kooij and colleagues.
“MTX successes” included the 79 patients who achieved a disease activity score (DAS) of 2.4 after 2 years of methotrexate monotherapy. “MTX failures” included the 66% of patients in the study who initially received MTX 15–25 mg/wk but who discontinued the drug because of toxicity or failure to achieve a DAS of 2.4 or less after 2 years, according to the investigators. These patients were then randomized to receive either sequential monotherapy or a step-up combination therapy. A higher DAS at baseline and female sex were significantly and independently predictive of MTX failure.
Dr. van der Kooij and colleagues suggested that, following the failure of initial MTX therapy, treatment with an anti-tumor necrosis factor agent should not be delayed, given that “switching to or adding other conventional DMARDs offers little chance of clinical efficacy and allows progression of joint damage.”
BeST is supported by the Dutch government and the Dutch College of Health Insurance Companies.
Biologic Therapy Complicates Vaccination for Travel
LAS VEGAS — Solutions to several challenging treatment scenarios in patients undergoing biologic therapy for rheumatologic or dermatologic conditions were considered by a panel of experts at seminar sponsored by Skin Disease Education Foundation.
The head of the panel, Dr. Craig Leonardi, a dermatologist in private practice in St. Louis, presented one scenario in which a patient being treated with a biologic is about to travel abroad to a developing country for a brief visit and needs to get the recommended vaccinations. Among the questions he asked the panel: Should the patient get the vaccinations? If so, should he discontinue the biologic?
Discontinuing the biologic to get the vaccinations was deemed an option by the panel, but with caveats. “It depends on the agent,” said Dr. Robert Kalb of the State University of New York at Buffalo. “If the person's on etanercept, and it's a short visit, [discontinuation is] certainly a very reasonable option. [If] the person's on efalizumab, I'd be a little bit more leery. The half-life of infliximab is such that, depending on the timing of the infusion, you might be able to get away with it.” He noted that he advises continuing the biologic during vaccinations that use killed vaccine and thus there is no reason to stop therapy for influenza or pneumonia vaccinations.
Dr. Bruce Strober of New York University, New York, said that stopping the biologic makes it more likely the vaccine will be at its peak efficacy. “I think there are some tangential studies that show if you give some types of vaccines in the midst of biologic therapy, some immunologic readouts are reduced, but the clinical relevance of that hasn't been established.” He noted that live vaccines are contraindicated with biologics. As to the length of time for biologic discontinuation in the setting of live vaccine use, “you would like the biologic to be more or less inactive in the patient, so four to five half-lives,” he said.
This estimate was shared by panelist Dr. Francisco Kerdel of Cedars Medical Center in Miami, who also raised the question of whether biologic treatment brings an increased risk of contracting disease, especially in regions with a greater number and variety of nefarious microbes. “When you talk about the granulomatous diseases being activated by the use of anti-[tumor necrosis factor], most of the time it applies to patients reactivating what they already have,” he said.
Dr. Strober suggested that physicians ask patients taking biologics about their future travel plans and vaccinations.
Flare-up of the disease itself is one of the foremost risks of stopping a biologic, especially efalizumab, Dr. Leonardi noted. Disease rebound is less of a risk, however, with TNF-α antagonists.
Another challenging scenario that Dr. Leonardi presented involved an elderly patient with psoriatic arthritis and heart failure (HF) who is unwilling to accept conventional treatment and insists on biologic therapy.
“I think you need to define the severity of HF,” Dr. Strober said, adding that studies of etanercept and infliximab showed that only patients with very severe heart failure experienced problems on infliximab, and only on the highest dose of 10 mg/kg. He advised consulting with a cardiologist to determine if tumor necrosis factor inhibitors are an option. Even so, he suggested trying efalizumab or alefacept first.
The panel also discussed the issue of weight and body mass index with biologic therapy. Morbidly obese patients don't respond as well to etanercept, Dr. Kalb noted, but the biologics with weight-based dosing, efalizumab and infliximab, have demonstrated similar responses in patients with and without high body mass index. Part of the difficulty in treating heavier patients may lie in weight-based dosing.
The final scenario presented involved a patient on a biologic who is about to undergo elective surgery for chronic cholecystitis refractory to antibiotics. Dr. Leonardi advised stopping the biologic and restarting it after surgery, except in the case of etanercept. Biologics might pose some effect on postsurgical wound healing and infection risk, but little is known about such interactions, Dr. Kerdel said.
It is important, however, to tell the surgeon what biologic the patient is taking, Dr. Leonardi said. “The surgeon may have no idea what these medicines are,” he said.
Dr. Kalb noted that many patients with Crohn's disease need surgery and that many continue taking infliximab.
Dr. Kerdel noted that if the cholecystitis patient is taking efalizumab, “I would continue [treatment], because I think the risk of having a rebound phenomenon … would be greater than the risk of infections that we know of.”
Dr. Leonardi is a consultant for Amgen, Abbott, Genentech, and Centocor. Dr. Kerdel is a consultant for Abbott, Amgen, and Centocor.
Dr. Kalb has been a consultant for the latter three firms, as well as for Genentech. Dr. Strober has received funding from, advised, or been a speaker for Genentech, Amgen/Wyeth, Centocor, Abbott, and Astellas.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
LAS VEGAS — Solutions to several challenging treatment scenarios in patients undergoing biologic therapy for rheumatologic or dermatologic conditions were considered by a panel of experts at seminar sponsored by Skin Disease Education Foundation.
The head of the panel, Dr. Craig Leonardi, a dermatologist in private practice in St. Louis, presented one scenario in which a patient being treated with a biologic is about to travel abroad to a developing country for a brief visit and needs to get the recommended vaccinations. Among the questions he asked the panel: Should the patient get the vaccinations? If so, should he discontinue the biologic?
Discontinuing the biologic to get the vaccinations was deemed an option by the panel, but with caveats. “It depends on the agent,” said Dr. Robert Kalb of the State University of New York at Buffalo. “If the person's on etanercept, and it's a short visit, [discontinuation is] certainly a very reasonable option. [If] the person's on efalizumab, I'd be a little bit more leery. The half-life of infliximab is such that, depending on the timing of the infusion, you might be able to get away with it.” He noted that he advises continuing the biologic during vaccinations that use killed vaccine and thus there is no reason to stop therapy for influenza or pneumonia vaccinations.
Dr. Bruce Strober of New York University, New York, said that stopping the biologic makes it more likely the vaccine will be at its peak efficacy. “I think there are some tangential studies that show if you give some types of vaccines in the midst of biologic therapy, some immunologic readouts are reduced, but the clinical relevance of that hasn't been established.” He noted that live vaccines are contraindicated with biologics. As to the length of time for biologic discontinuation in the setting of live vaccine use, “you would like the biologic to be more or less inactive in the patient, so four to five half-lives,” he said.
This estimate was shared by panelist Dr. Francisco Kerdel of Cedars Medical Center in Miami, who also raised the question of whether biologic treatment brings an increased risk of contracting disease, especially in regions with a greater number and variety of nefarious microbes. “When you talk about the granulomatous diseases being activated by the use of anti-[tumor necrosis factor], most of the time it applies to patients reactivating what they already have,” he said.
Dr. Strober suggested that physicians ask patients taking biologics about their future travel plans and vaccinations.
Flare-up of the disease itself is one of the foremost risks of stopping a biologic, especially efalizumab, Dr. Leonardi noted. Disease rebound is less of a risk, however, with TNF-α antagonists.
Another challenging scenario that Dr. Leonardi presented involved an elderly patient with psoriatic arthritis and heart failure (HF) who is unwilling to accept conventional treatment and insists on biologic therapy.
“I think you need to define the severity of HF,” Dr. Strober said, adding that studies of etanercept and infliximab showed that only patients with very severe heart failure experienced problems on infliximab, and only on the highest dose of 10 mg/kg. He advised consulting with a cardiologist to determine if tumor necrosis factor inhibitors are an option. Even so, he suggested trying efalizumab or alefacept first.
The panel also discussed the issue of weight and body mass index with biologic therapy. Morbidly obese patients don't respond as well to etanercept, Dr. Kalb noted, but the biologics with weight-based dosing, efalizumab and infliximab, have demonstrated similar responses in patients with and without high body mass index. Part of the difficulty in treating heavier patients may lie in weight-based dosing.
The final scenario presented involved a patient on a biologic who is about to undergo elective surgery for chronic cholecystitis refractory to antibiotics. Dr. Leonardi advised stopping the biologic and restarting it after surgery, except in the case of etanercept. Biologics might pose some effect on postsurgical wound healing and infection risk, but little is known about such interactions, Dr. Kerdel said.
It is important, however, to tell the surgeon what biologic the patient is taking, Dr. Leonardi said. “The surgeon may have no idea what these medicines are,” he said.
Dr. Kalb noted that many patients with Crohn's disease need surgery and that many continue taking infliximab.
Dr. Kerdel noted that if the cholecystitis patient is taking efalizumab, “I would continue [treatment], because I think the risk of having a rebound phenomenon … would be greater than the risk of infections that we know of.”
Dr. Leonardi is a consultant for Amgen, Abbott, Genentech, and Centocor. Dr. Kerdel is a consultant for Abbott, Amgen, and Centocor.
Dr. Kalb has been a consultant for the latter three firms, as well as for Genentech. Dr. Strober has received funding from, advised, or been a speaker for Genentech, Amgen/Wyeth, Centocor, Abbott, and Astellas.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
LAS VEGAS — Solutions to several challenging treatment scenarios in patients undergoing biologic therapy for rheumatologic or dermatologic conditions were considered by a panel of experts at seminar sponsored by Skin Disease Education Foundation.
The head of the panel, Dr. Craig Leonardi, a dermatologist in private practice in St. Louis, presented one scenario in which a patient being treated with a biologic is about to travel abroad to a developing country for a brief visit and needs to get the recommended vaccinations. Among the questions he asked the panel: Should the patient get the vaccinations? If so, should he discontinue the biologic?
Discontinuing the biologic to get the vaccinations was deemed an option by the panel, but with caveats. “It depends on the agent,” said Dr. Robert Kalb of the State University of New York at Buffalo. “If the person's on etanercept, and it's a short visit, [discontinuation is] certainly a very reasonable option. [If] the person's on efalizumab, I'd be a little bit more leery. The half-life of infliximab is such that, depending on the timing of the infusion, you might be able to get away with it.” He noted that he advises continuing the biologic during vaccinations that use killed vaccine and thus there is no reason to stop therapy for influenza or pneumonia vaccinations.
Dr. Bruce Strober of New York University, New York, said that stopping the biologic makes it more likely the vaccine will be at its peak efficacy. “I think there are some tangential studies that show if you give some types of vaccines in the midst of biologic therapy, some immunologic readouts are reduced, but the clinical relevance of that hasn't been established.” He noted that live vaccines are contraindicated with biologics. As to the length of time for biologic discontinuation in the setting of live vaccine use, “you would like the biologic to be more or less inactive in the patient, so four to five half-lives,” he said.
This estimate was shared by panelist Dr. Francisco Kerdel of Cedars Medical Center in Miami, who also raised the question of whether biologic treatment brings an increased risk of contracting disease, especially in regions with a greater number and variety of nefarious microbes. “When you talk about the granulomatous diseases being activated by the use of anti-[tumor necrosis factor], most of the time it applies to patients reactivating what they already have,” he said.
Dr. Strober suggested that physicians ask patients taking biologics about their future travel plans and vaccinations.
Flare-up of the disease itself is one of the foremost risks of stopping a biologic, especially efalizumab, Dr. Leonardi noted. Disease rebound is less of a risk, however, with TNF-α antagonists.
Another challenging scenario that Dr. Leonardi presented involved an elderly patient with psoriatic arthritis and heart failure (HF) who is unwilling to accept conventional treatment and insists on biologic therapy.
“I think you need to define the severity of HF,” Dr. Strober said, adding that studies of etanercept and infliximab showed that only patients with very severe heart failure experienced problems on infliximab, and only on the highest dose of 10 mg/kg. He advised consulting with a cardiologist to determine if tumor necrosis factor inhibitors are an option. Even so, he suggested trying efalizumab or alefacept first.
The panel also discussed the issue of weight and body mass index with biologic therapy. Morbidly obese patients don't respond as well to etanercept, Dr. Kalb noted, but the biologics with weight-based dosing, efalizumab and infliximab, have demonstrated similar responses in patients with and without high body mass index. Part of the difficulty in treating heavier patients may lie in weight-based dosing.
The final scenario presented involved a patient on a biologic who is about to undergo elective surgery for chronic cholecystitis refractory to antibiotics. Dr. Leonardi advised stopping the biologic and restarting it after surgery, except in the case of etanercept. Biologics might pose some effect on postsurgical wound healing and infection risk, but little is known about such interactions, Dr. Kerdel said.
It is important, however, to tell the surgeon what biologic the patient is taking, Dr. Leonardi said. “The surgeon may have no idea what these medicines are,” he said.
Dr. Kalb noted that many patients with Crohn's disease need surgery and that many continue taking infliximab.
Dr. Kerdel noted that if the cholecystitis patient is taking efalizumab, “I would continue [treatment], because I think the risk of having a rebound phenomenon … would be greater than the risk of infections that we know of.”
Dr. Leonardi is a consultant for Amgen, Abbott, Genentech, and Centocor. Dr. Kerdel is a consultant for Abbott, Amgen, and Centocor.
Dr. Kalb has been a consultant for the latter three firms, as well as for Genentech. Dr. Strober has received funding from, advised, or been a speaker for Genentech, Amgen/Wyeth, Centocor, Abbott, and Astellas.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
Steroid Injections for Lumbosacral Pain Have Limited Role
Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.
“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.
“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.
The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).
From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.
Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”
“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.
People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.
Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.
The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.
Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.
“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.
“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.
The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).
From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.
Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”
“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.
People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.
Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.
The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.
Epidural steroid injections may provide some short-term pain relief in radicular lumbosacral pain, but they are not recommended for long-term relief, improvement of function, or reducing the need for surgery, according to new guidelines from the American Academy of Neurology.
“The conclusion [of the AAN report] is that these injections are not overwhelmingly therapeutic, and I would say that is fair—they don't cure this problem—but they help certain patients, and I think when all is said and done, you have a better chance of helping someone [with epidural steroid injections] than harming them,” Dr. David Borenstein, a Washington rheumatologist who specializes in low back pain, said during an interview.
“When it comes down to the clinical situation, I think what's important is the risk benefit ratio,” said Dr. Borenstein, also of George Washington University, Washington.
The guidelines were drafted by the academy's (AAN's) Therapeutics and Technology Assessment Subcommittee and are based on a literature review (Neurology 2007;68:723–9).
From an initial 37 studies that were identified, only 4 met the committee's predetermined inclusion criteria of being randomized, double-blinded, and placebo or active-controlled with a clear case definition and clear pain-relief outcomes using a standardized measure, wrote lead author Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass., and professor of neurology at Tufts University in Boston.
Dr. Armon and colleagues reported that all four studies were consistent regarding their findings on epidural steroid injection for radicular lumbosacral pain relief. The findings concluded that when compared with a control group, the injections proved “no efficacy at 24 hours, some efficacy at 2–6 weeks, no difference or rebound worsening at 3 months and 6 months, and no difference at 1 year.”
“While some pain relief is a positive result in and of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful,” Dr. Armon wrote. The clinically meaningful effect is usually defined as 15 mm on a 100-mm visual analog pain scale, according to the guidelines.
People should consider exercises and oral therapies first, but if they're not getting better, this relatively noninvasive type of procedure, compared to surgical intervention, would be worthwhile to consider in the appropriate patient, said Dr. Borenstein, during the interview.
Reported complications of epidural steroid injections are usually minor and transient—most frequently a headache, they reported. Major complications are rare and include aseptic meningitis, arachnoiditis, bacterial meningitis, epidural abscess, and conus medullaris syndrome.
The authors noted that current data on the use of epidural steroid injections to treat cervical radicular pain are inadequate to make recommendations.
Not Every Joint Replacement Advance Improves Outcomes
SNOWMASS, COLO. — Patients considering joint replacement are coming in to the office with some pretty specific questions these days. They want to know more about gender-specific knees, minimally invasive knee replacement, computer-assisted surgery, new indestructible materials, high-flexion designs, and rotating platforms, said Dr. Thomas S. Thornhill, chairman of the department of orthopedic surgery at Brigham and Women's Hospital in Boston.
Dr. Thornhill offered his thoughts on these issues at a symposium sponsored by the American College of Rheumatology.
Gender-Specific Knees
Approved in 2006, the Gender Solutions implant (made by Zimmer Inc.) was the first knee prosthesis to target the female knee. The company promotes the implant in part by stating that the implant better fits the size and shape of a woman's knee.
“There are really no significant clinical differences between male and female problems with the knee,” said Dr. Thornhill. In fact, some studies suggest that survivorship in total knee replacement may even be better in women.
Men typically have knees that are broader in the medial-lateral dimension than in the anterior-posterior dimension. Women tend to have knees that are narrower in the medial-lateral dimension and a little longer in the anterior-posterior dimension.
While there clearly are differences between the aspect ratios of men and women, some research suggests that the differences among women and among men are greater than those between the sexes are.
Minimally Invasive Knee Replacement
Patients will come in asking for minimally invasive knee replacements but it's not clear what this means. What patients think of as minimally invasive surgery actually is combined with many other variables: patient education and selection, preemptive analgesia, better postoperative pain control, and more rapid mobilization.
Computer-Assisted Surgery
Computer-assisted surgery does have the advantage of eliminating some of the outliers of alignment.
Computer-assisted surgery has much potential as a teaching tool, partly because it can provide feedback to surgeons. “The trouble is it costs a lot of money and it increases the surgical time,” said Dr. Thornhill.
New Materials, High-Flexion Designs
Patients are interested in new, longer-lasting materials, such as ceramic-on-ceramic joints. What patients don't generally know is that there is a 6% incidence of squeaking in patients with ceramic-on-ceramic replacement hip joints, said Dr. Thornhill. Other options, such as cartilage repair/regeneration techniques, primarily are performed on an experimental basis for osteochondral defects.
In terms of postoperative flexion, the most important factor actually is preoperative flexion, said Dr. Thornhill. High-flexion designs “add little functional value.” These designs do increase the cost though.
Rotating Platforms
Rotating platforms allow rotation around a central axis, supposedly improving kinematics. However, the human knee does not rotate, Dr. Thornhill noted. These implants have unidirectional wear, which is a theoretical advantage, but studies have not shown that the range of motion is any better with rotating platforms.
Dr. Thornhill disclosed that he receives royalties from DePuy Inc. He also has received research grants from DePuy Inc., Biomet Inc., and Smith & Nephew.
SNOWMASS, COLO. — Patients considering joint replacement are coming in to the office with some pretty specific questions these days. They want to know more about gender-specific knees, minimally invasive knee replacement, computer-assisted surgery, new indestructible materials, high-flexion designs, and rotating platforms, said Dr. Thomas S. Thornhill, chairman of the department of orthopedic surgery at Brigham and Women's Hospital in Boston.
Dr. Thornhill offered his thoughts on these issues at a symposium sponsored by the American College of Rheumatology.
Gender-Specific Knees
Approved in 2006, the Gender Solutions implant (made by Zimmer Inc.) was the first knee prosthesis to target the female knee. The company promotes the implant in part by stating that the implant better fits the size and shape of a woman's knee.
“There are really no significant clinical differences between male and female problems with the knee,” said Dr. Thornhill. In fact, some studies suggest that survivorship in total knee replacement may even be better in women.
Men typically have knees that are broader in the medial-lateral dimension than in the anterior-posterior dimension. Women tend to have knees that are narrower in the medial-lateral dimension and a little longer in the anterior-posterior dimension.
While there clearly are differences between the aspect ratios of men and women, some research suggests that the differences among women and among men are greater than those between the sexes are.
Minimally Invasive Knee Replacement
Patients will come in asking for minimally invasive knee replacements but it's not clear what this means. What patients think of as minimally invasive surgery actually is combined with many other variables: patient education and selection, preemptive analgesia, better postoperative pain control, and more rapid mobilization.
Computer-Assisted Surgery
Computer-assisted surgery does have the advantage of eliminating some of the outliers of alignment.
Computer-assisted surgery has much potential as a teaching tool, partly because it can provide feedback to surgeons. “The trouble is it costs a lot of money and it increases the surgical time,” said Dr. Thornhill.
New Materials, High-Flexion Designs
Patients are interested in new, longer-lasting materials, such as ceramic-on-ceramic joints. What patients don't generally know is that there is a 6% incidence of squeaking in patients with ceramic-on-ceramic replacement hip joints, said Dr. Thornhill. Other options, such as cartilage repair/regeneration techniques, primarily are performed on an experimental basis for osteochondral defects.
In terms of postoperative flexion, the most important factor actually is preoperative flexion, said Dr. Thornhill. High-flexion designs “add little functional value.” These designs do increase the cost though.
Rotating Platforms
Rotating platforms allow rotation around a central axis, supposedly improving kinematics. However, the human knee does not rotate, Dr. Thornhill noted. These implants have unidirectional wear, which is a theoretical advantage, but studies have not shown that the range of motion is any better with rotating platforms.
Dr. Thornhill disclosed that he receives royalties from DePuy Inc. He also has received research grants from DePuy Inc., Biomet Inc., and Smith & Nephew.
SNOWMASS, COLO. — Patients considering joint replacement are coming in to the office with some pretty specific questions these days. They want to know more about gender-specific knees, minimally invasive knee replacement, computer-assisted surgery, new indestructible materials, high-flexion designs, and rotating platforms, said Dr. Thomas S. Thornhill, chairman of the department of orthopedic surgery at Brigham and Women's Hospital in Boston.
Dr. Thornhill offered his thoughts on these issues at a symposium sponsored by the American College of Rheumatology.
Gender-Specific Knees
Approved in 2006, the Gender Solutions implant (made by Zimmer Inc.) was the first knee prosthesis to target the female knee. The company promotes the implant in part by stating that the implant better fits the size and shape of a woman's knee.
“There are really no significant clinical differences between male and female problems with the knee,” said Dr. Thornhill. In fact, some studies suggest that survivorship in total knee replacement may even be better in women.
Men typically have knees that are broader in the medial-lateral dimension than in the anterior-posterior dimension. Women tend to have knees that are narrower in the medial-lateral dimension and a little longer in the anterior-posterior dimension.
While there clearly are differences between the aspect ratios of men and women, some research suggests that the differences among women and among men are greater than those between the sexes are.
Minimally Invasive Knee Replacement
Patients will come in asking for minimally invasive knee replacements but it's not clear what this means. What patients think of as minimally invasive surgery actually is combined with many other variables: patient education and selection, preemptive analgesia, better postoperative pain control, and more rapid mobilization.
Computer-Assisted Surgery
Computer-assisted surgery does have the advantage of eliminating some of the outliers of alignment.
Computer-assisted surgery has much potential as a teaching tool, partly because it can provide feedback to surgeons. “The trouble is it costs a lot of money and it increases the surgical time,” said Dr. Thornhill.
New Materials, High-Flexion Designs
Patients are interested in new, longer-lasting materials, such as ceramic-on-ceramic joints. What patients don't generally know is that there is a 6% incidence of squeaking in patients with ceramic-on-ceramic replacement hip joints, said Dr. Thornhill. Other options, such as cartilage repair/regeneration techniques, primarily are performed on an experimental basis for osteochondral defects.
In terms of postoperative flexion, the most important factor actually is preoperative flexion, said Dr. Thornhill. High-flexion designs “add little functional value.” These designs do increase the cost though.
Rotating Platforms
Rotating platforms allow rotation around a central axis, supposedly improving kinematics. However, the human knee does not rotate, Dr. Thornhill noted. These implants have unidirectional wear, which is a theoretical advantage, but studies have not shown that the range of motion is any better with rotating platforms.
Dr. Thornhill disclosed that he receives royalties from DePuy Inc. He also has received research grants from DePuy Inc., Biomet Inc., and Smith & Nephew.
FACIT-Fatigue Scale Found Valid for Psoriatic Arthritis
The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.
One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).
All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).
The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.
Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.
More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.
The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.
Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.
The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.
One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).
All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).
The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.
Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.
More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.
The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.
Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.
The Functional Assessment of Chronic Illness Therapy-Fatigue scale is a reliable and valid instrument for measuring fatigue in patients with psoriatic arthritis, a study has found.
One of a number of self-reported scales used to measure fatigue in patients with arthritis, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has garnered interest in rheumatologic drug trials for its capacity to demonstrate decreases in fatigue associated with pharmacotherapy, according to Dr. Vinod Chandron of Toronto Western Hospital, and colleagues. Although the measure has demonstrated promise in clinical trials, it has not been validated in patients with psoriatic arthritis specifically, the authors wrote. Therefore, the investigators enrolled 135 consecutive patients from the University of Toronto psoriatic arthritis clinic in a study designed to determine the internal consistency, test-retest reliability, criterion, and construct validity of the FACIT-Fatigue scale in this population (Ann. Rheum. Dis. 2007 Feb. 26 [Epub doi:10.1136/ard.2006.065763]).
All study patients underwent a standardized clinical assessment including complete history, physical examination, and laboratory evaluation, Dr. Chandron and investigators reported. Laboratory testing included hemoglobin measurement and erythrocyte sedimentation rate (ESR).
The patients were asked to complete the FACIT-Fatigue questionnaire at the clinic and again 1 week later to assess test-retest reliability using the intraclass correlation coefficient (ICC). They also were asked to complete the Modified Fatigue Severity Scale (mFSS) to evaluate the construct validity of the FACIT-Fatigue measure.
Among the 80 men and 55 women (mean age 52 years) in the investigation, the mean disease duration was 17 years; the mean Psoriasis Area Severity Index score was 3.5, with the mean counts for actively inflamed, swollen, and clinically damaged joints being 4.5, 1.3, and 8.7, respectively. Of the 135 patients, 16 met the clinical criteria for fibromyalgia, 27 had anemia, 63 had elevated ESR levels, and 26 had overwhelming fatigue. The mean FACIT-Fatigue score in the study population was 35.8 out of a possible 52, according to the investigators.
More than half of the patients (54%) returned the repeat questionnaires. There was no difference in disease characteristics between those who did and did not return the questionnaires, the authors reported. The ICC between first and repeat scores was high, at 0.95. Additionally, the Cronbach's alpha of the 13 FACIT-Fatigue items was 0.96, indicating a high level of internal consistency.
The correlation between the FACIT-Fatigue and the mFSS was high, at −0.79. “The negative sign reflects the fact that higher scores in the FACIT-Fatigue indicate less fatigue whereas higher scores in the mFSS indicated more fatigue,” the investigators explained. The FACIT-Fatigue scores also correlated with actively inflamed joint count and swollen joint count but not with clinically damaged joint count, the authors observed. There were no differences in the FACIT-Fatigue scores between patients with and without elevated ESR or anemia, and males and females scored similarly.
Among patients reporting overwhelming fatigue, the FACIT-Fatigue scores were lower, meaning more fatigue, compared with those who did not report overwhelming fatigue, the authors stated.
Inflammatory Hand Pain May Respond to Methylprednisolone
Intramuscular methylprednisolone can significantly improve symptoms and function in patients with inflammatory hand pain, a proof of concept study has shown.
To test the hypothesis that predominant hand pain with diurnal variation and morning stiffness lasting for at least 30 minutes has an inflammatory etiology and should respond to corticosteroids, Dr. Zunaid Karim of Chapel Allerton Hospital in Leeds, England, and colleagues evaluated the efficacy of intramuscular methylprednisolone treatment in 102 patients who presented to the Leeds Early Arthritis Clinic with more than 3 months of symptoms and who had failed to respond to nonsteroidal anti-inflammatory drugs (Ann. Rheum. Dis. 2007 Jan. 22 [Epub: doi:10.1136/ard.2006.061861]). Patients with clinical synovitis in five or more joints, as well as those with gout, connective tissue disease, or rheumatoid arthritis were excluded, as were those with sensitivity to corticosteroids or hydroxychloroquine.
The presence of two of the following three conditions was considered indicative of clinical synovitis: joint swelling, joint tenderness, and reduced range of movement. Ultrasound was performed on the second to fifth metacarpal, phalangeal, and proximal interphalangeal joints, and synovitis was defined as the presence of abnormally hypoechoic intra-articular tissue that was nondisplaceable and poorly compressible.
At baseline, 21% of the patients were rheumatoid factor positive, 25% had elevated C-reactive protein levels, and 5% tested positive for antinuclear antibodies, the authors reported. Additionally, 23% of the patients had clinical synovitis and 55% had ultrasound-detected synovitis.
Participating patients received an intramuscular injection of 120 mg of methylprednisolone at baseline and were assessed for response (defined as 50% improvement in pain and stiffness symptoms) at 4 weeks, then every 12 weeks for 48 weeks. Patients who responded initially but subsequently relapsed received an additional methylprednisolone injection and were started on 200 mg daily of hydroxychloroquine, with response assessment after 24 weeks.
Of the initial 102 patients, 11 did not complete the 4-week assessment and were excluded from the study. The remaining 91 patients, mean age 51 years, were predominantly female (81%) and had a mean symptom duration of 7 months.
Response at 4 weeks was observed in 66 of the 91 patients (73%), with associated significant reductions in morning stiffness, Health Assessment Questionnaire results, painful and tender joint counts, and patient visual analog scores, the authors wrote. Both ultrasound-detected synovitis and rheumatoid factor were associated significantly with methylprednisolone response, while clinical synovitis and elevated C-reactive protein were not, the investigators reported.
Of the 66 responders, 24 remained well to the end of the study. The remaining 42 patients relapsed within 24 weeks and received a repeat methylprednisolone injection and hydroxychloroquine. Of these patients, 28 remained on the drug long term and 24 of the 28 reported a benefit, the authors noted. The findings may be limited by the lack of sensitivity of the clinical synovitis assessment. Additionally, it is unclear whether the response seen in the hydroxychloroquine group is a function of the repeat methylprednisolone injection or the hydroxychloroquine.
Intramuscular methylprednisolone can significantly improve symptoms and function in patients with inflammatory hand pain, a proof of concept study has shown.
To test the hypothesis that predominant hand pain with diurnal variation and morning stiffness lasting for at least 30 minutes has an inflammatory etiology and should respond to corticosteroids, Dr. Zunaid Karim of Chapel Allerton Hospital in Leeds, England, and colleagues evaluated the efficacy of intramuscular methylprednisolone treatment in 102 patients who presented to the Leeds Early Arthritis Clinic with more than 3 months of symptoms and who had failed to respond to nonsteroidal anti-inflammatory drugs (Ann. Rheum. Dis. 2007 Jan. 22 [Epub: doi:10.1136/ard.2006.061861]). Patients with clinical synovitis in five or more joints, as well as those with gout, connective tissue disease, or rheumatoid arthritis were excluded, as were those with sensitivity to corticosteroids or hydroxychloroquine.
The presence of two of the following three conditions was considered indicative of clinical synovitis: joint swelling, joint tenderness, and reduced range of movement. Ultrasound was performed on the second to fifth metacarpal, phalangeal, and proximal interphalangeal joints, and synovitis was defined as the presence of abnormally hypoechoic intra-articular tissue that was nondisplaceable and poorly compressible.
At baseline, 21% of the patients were rheumatoid factor positive, 25% had elevated C-reactive protein levels, and 5% tested positive for antinuclear antibodies, the authors reported. Additionally, 23% of the patients had clinical synovitis and 55% had ultrasound-detected synovitis.
Participating patients received an intramuscular injection of 120 mg of methylprednisolone at baseline and were assessed for response (defined as 50% improvement in pain and stiffness symptoms) at 4 weeks, then every 12 weeks for 48 weeks. Patients who responded initially but subsequently relapsed received an additional methylprednisolone injection and were started on 200 mg daily of hydroxychloroquine, with response assessment after 24 weeks.
Of the initial 102 patients, 11 did not complete the 4-week assessment and were excluded from the study. The remaining 91 patients, mean age 51 years, were predominantly female (81%) and had a mean symptom duration of 7 months.
Response at 4 weeks was observed in 66 of the 91 patients (73%), with associated significant reductions in morning stiffness, Health Assessment Questionnaire results, painful and tender joint counts, and patient visual analog scores, the authors wrote. Both ultrasound-detected synovitis and rheumatoid factor were associated significantly with methylprednisolone response, while clinical synovitis and elevated C-reactive protein were not, the investigators reported.
Of the 66 responders, 24 remained well to the end of the study. The remaining 42 patients relapsed within 24 weeks and received a repeat methylprednisolone injection and hydroxychloroquine. Of these patients, 28 remained on the drug long term and 24 of the 28 reported a benefit, the authors noted. The findings may be limited by the lack of sensitivity of the clinical synovitis assessment. Additionally, it is unclear whether the response seen in the hydroxychloroquine group is a function of the repeat methylprednisolone injection or the hydroxychloroquine.
Intramuscular methylprednisolone can significantly improve symptoms and function in patients with inflammatory hand pain, a proof of concept study has shown.
To test the hypothesis that predominant hand pain with diurnal variation and morning stiffness lasting for at least 30 minutes has an inflammatory etiology and should respond to corticosteroids, Dr. Zunaid Karim of Chapel Allerton Hospital in Leeds, England, and colleagues evaluated the efficacy of intramuscular methylprednisolone treatment in 102 patients who presented to the Leeds Early Arthritis Clinic with more than 3 months of symptoms and who had failed to respond to nonsteroidal anti-inflammatory drugs (Ann. Rheum. Dis. 2007 Jan. 22 [Epub: doi:10.1136/ard.2006.061861]). Patients with clinical synovitis in five or more joints, as well as those with gout, connective tissue disease, or rheumatoid arthritis were excluded, as were those with sensitivity to corticosteroids or hydroxychloroquine.
The presence of two of the following three conditions was considered indicative of clinical synovitis: joint swelling, joint tenderness, and reduced range of movement. Ultrasound was performed on the second to fifth metacarpal, phalangeal, and proximal interphalangeal joints, and synovitis was defined as the presence of abnormally hypoechoic intra-articular tissue that was nondisplaceable and poorly compressible.
At baseline, 21% of the patients were rheumatoid factor positive, 25% had elevated C-reactive protein levels, and 5% tested positive for antinuclear antibodies, the authors reported. Additionally, 23% of the patients had clinical synovitis and 55% had ultrasound-detected synovitis.
Participating patients received an intramuscular injection of 120 mg of methylprednisolone at baseline and were assessed for response (defined as 50% improvement in pain and stiffness symptoms) at 4 weeks, then every 12 weeks for 48 weeks. Patients who responded initially but subsequently relapsed received an additional methylprednisolone injection and were started on 200 mg daily of hydroxychloroquine, with response assessment after 24 weeks.
Of the initial 102 patients, 11 did not complete the 4-week assessment and were excluded from the study. The remaining 91 patients, mean age 51 years, were predominantly female (81%) and had a mean symptom duration of 7 months.
Response at 4 weeks was observed in 66 of the 91 patients (73%), with associated significant reductions in morning stiffness, Health Assessment Questionnaire results, painful and tender joint counts, and patient visual analog scores, the authors wrote. Both ultrasound-detected synovitis and rheumatoid factor were associated significantly with methylprednisolone response, while clinical synovitis and elevated C-reactive protein were not, the investigators reported.
Of the 66 responders, 24 remained well to the end of the study. The remaining 42 patients relapsed within 24 weeks and received a repeat methylprednisolone injection and hydroxychloroquine. Of these patients, 28 remained on the drug long term and 24 of the 28 reported a benefit, the authors noted. The findings may be limited by the lack of sensitivity of the clinical synovitis assessment. Additionally, it is unclear whether the response seen in the hydroxychloroquine group is a function of the repeat methylprednisolone injection or the hydroxychloroquine.
Adalimumab Autoinjection Pen Preferred Over Prefilled Syringe
WASHINGTON — Patients with active rheumatoid arthritis preferred the adalimumab autoinjection pen device to the prefilled syringe in an Abbott-sponsored study, Dr. Martin Okun reported in a poster presentation at the annual meeting of the American Academy of Dermatology.
Adalimumab, a fully human IgG monoclonal anti-tumor necrosis factor, is approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It can be administered via subcutaneous injection with a prefilled syringe or by an autoinjection pen, which was developed to facilitate self-injection by patients with physically limiting autoimmune diseases, noted Dr. Okun of Abbott Laboratory's department of medical affairs.
The investigators evaluated existing data from an earlier open-label phase II study that was done in pursuit of the original Food and Drug Administration approval of 52 patients with active RA who self-administered 40 mg adalimumab subcutaneously with the syringe at visit 1, followed by the same dose via the pen at visits 2 (at week 2) and 3 (week 4). The patients chose the site—either thigh or abdomen—and maintained the same site for all three injections.
The patients had a mean age of 54 years and a mean RA duration of 8 years. Two-thirds were women, and the majority (88.5%) were white. They had been injecting adalimumab via syringe for a mean of 15 months.
On the 10-point visual analog scale, with 0 being “no pain” and 10 being “as bad as it could be,” the patients rated their pain immediately following injection as a mean of 3.7 with the syringe at visit 1, compared with 2.3 and 2.0, respectively, for the pen at visits 2 and 3.
Overall, 40 patients (77%) deemed the pen to be less painful than the syringe, while 4 patients (8%) found the syringe less painful and 8 (15%) had no preference. Significant reductions in injection-site pain were observed at 15–30 minutes post injection with the pen, Dr. Okun reported.
Overall impressions of the injection experience with the pen were rated “favorable” or “extremely favorable” by 86.5% at visit 2 and 88.5% at visit 3, compared with just 32.6% for the syringe at visit 1. Overall preference was 88.5% for the pen compared with 5.8% for the syringe and 5.8% with no preference.
Reasons listed for preferring the pen included ease of use, convenience, time to inject (about 10 seconds versus 30 seconds for the syringe), safety, and “less pain.” More than 94% of the patients said they would likely use the pen if it were available at the same cost as the syringe, and the same proportion said they would recommend the pen to another patient, Dr. Okun reported.
Poster session moderator Dr. Craig Leonardi, a dermatologist at St. Louis University, cautioned that patients must be trained to use the pen. “It's not sufficient to just prescribe the pen. You have to show patients how to use it. Otherwise they make mistakes.”
WASHINGTON — Patients with active rheumatoid arthritis preferred the adalimumab autoinjection pen device to the prefilled syringe in an Abbott-sponsored study, Dr. Martin Okun reported in a poster presentation at the annual meeting of the American Academy of Dermatology.
Adalimumab, a fully human IgG monoclonal anti-tumor necrosis factor, is approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It can be administered via subcutaneous injection with a prefilled syringe or by an autoinjection pen, which was developed to facilitate self-injection by patients with physically limiting autoimmune diseases, noted Dr. Okun of Abbott Laboratory's department of medical affairs.
The investigators evaluated existing data from an earlier open-label phase II study that was done in pursuit of the original Food and Drug Administration approval of 52 patients with active RA who self-administered 40 mg adalimumab subcutaneously with the syringe at visit 1, followed by the same dose via the pen at visits 2 (at week 2) and 3 (week 4). The patients chose the site—either thigh or abdomen—and maintained the same site for all three injections.
The patients had a mean age of 54 years and a mean RA duration of 8 years. Two-thirds were women, and the majority (88.5%) were white. They had been injecting adalimumab via syringe for a mean of 15 months.
On the 10-point visual analog scale, with 0 being “no pain” and 10 being “as bad as it could be,” the patients rated their pain immediately following injection as a mean of 3.7 with the syringe at visit 1, compared with 2.3 and 2.0, respectively, for the pen at visits 2 and 3.
Overall, 40 patients (77%) deemed the pen to be less painful than the syringe, while 4 patients (8%) found the syringe less painful and 8 (15%) had no preference. Significant reductions in injection-site pain were observed at 15–30 minutes post injection with the pen, Dr. Okun reported.
Overall impressions of the injection experience with the pen were rated “favorable” or “extremely favorable” by 86.5% at visit 2 and 88.5% at visit 3, compared with just 32.6% for the syringe at visit 1. Overall preference was 88.5% for the pen compared with 5.8% for the syringe and 5.8% with no preference.
Reasons listed for preferring the pen included ease of use, convenience, time to inject (about 10 seconds versus 30 seconds for the syringe), safety, and “less pain.” More than 94% of the patients said they would likely use the pen if it were available at the same cost as the syringe, and the same proportion said they would recommend the pen to another patient, Dr. Okun reported.
Poster session moderator Dr. Craig Leonardi, a dermatologist at St. Louis University, cautioned that patients must be trained to use the pen. “It's not sufficient to just prescribe the pen. You have to show patients how to use it. Otherwise they make mistakes.”
WASHINGTON — Patients with active rheumatoid arthritis preferred the adalimumab autoinjection pen device to the prefilled syringe in an Abbott-sponsored study, Dr. Martin Okun reported in a poster presentation at the annual meeting of the American Academy of Dermatology.
Adalimumab, a fully human IgG monoclonal anti-tumor necrosis factor, is approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It can be administered via subcutaneous injection with a prefilled syringe or by an autoinjection pen, which was developed to facilitate self-injection by patients with physically limiting autoimmune diseases, noted Dr. Okun of Abbott Laboratory's department of medical affairs.
The investigators evaluated existing data from an earlier open-label phase II study that was done in pursuit of the original Food and Drug Administration approval of 52 patients with active RA who self-administered 40 mg adalimumab subcutaneously with the syringe at visit 1, followed by the same dose via the pen at visits 2 (at week 2) and 3 (week 4). The patients chose the site—either thigh or abdomen—and maintained the same site for all three injections.
The patients had a mean age of 54 years and a mean RA duration of 8 years. Two-thirds were women, and the majority (88.5%) were white. They had been injecting adalimumab via syringe for a mean of 15 months.
On the 10-point visual analog scale, with 0 being “no pain” and 10 being “as bad as it could be,” the patients rated their pain immediately following injection as a mean of 3.7 with the syringe at visit 1, compared with 2.3 and 2.0, respectively, for the pen at visits 2 and 3.
Overall, 40 patients (77%) deemed the pen to be less painful than the syringe, while 4 patients (8%) found the syringe less painful and 8 (15%) had no preference. Significant reductions in injection-site pain were observed at 15–30 minutes post injection with the pen, Dr. Okun reported.
Overall impressions of the injection experience with the pen were rated “favorable” or “extremely favorable” by 86.5% at visit 2 and 88.5% at visit 3, compared with just 32.6% for the syringe at visit 1. Overall preference was 88.5% for the pen compared with 5.8% for the syringe and 5.8% with no preference.
Reasons listed for preferring the pen included ease of use, convenience, time to inject (about 10 seconds versus 30 seconds for the syringe), safety, and “less pain.” More than 94% of the patients said they would likely use the pen if it were available at the same cost as the syringe, and the same proportion said they would recommend the pen to another patient, Dr. Okun reported.
Poster session moderator Dr. Craig Leonardi, a dermatologist at St. Louis University, cautioned that patients must be trained to use the pen. “It's not sufficient to just prescribe the pen. You have to show patients how to use it. Otherwise they make mistakes.”
Resuming Infliximab Seems Safe, Effective in AS
Readministration of infliximab was generally safe and effective in patients with ankylosing spondylitis who had previously discontinued treatment, reported Dr. Xenofon Baraliakos and colleagues.
Dr. Baraliakos, of Rheumazentrum Ruhrgebiet in Herne, Germany, and colleagues designed a study to evaluate the safety and efficacy of infliximab readministration in patients with ankylosing spondylitis who experienced clinical relapse following infliximab withdrawal (J. Rheumatol. 2007 Feb. 1; [Epub ahead of print]). The study population consisted of 42 patients with ankylosing spondylitis who had completed a 3-year, open-label extension study of continuous infliximab therapy administered by infusion at a dose of 5 mg/kg every 6 weeks.
Patients discontinued infliximab at the end of the third year of the open-label extension study. The date of infliximab withdrawal was defined as timepoint (TP) 1. Patients were assessed every 6 weeks after infliximab withdrawal for signs of disease flare, the investigators reported. Clinical relapse was defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater and a physician's global assessment score of 4 or greater. Patients who experienced clinical relapse were reinfused with infliximab at a dose of 5 mg/kg. The time of clinical relapse was defined as TP2.
Patients were reinfused every 6 weeks after TP2 for the duration of the study. Clinical data were obtained at each visit throughout the study. Study-specific data were collected at the time of infliximab withdrawal, at the time of clinical relapse, and at 24 and 48 weeks after TP2.
Of the 42 patients who enrolled in the study, one remained in clinical remission 48 weeks after infliximab withdrawal, the investigators noted. The remaining 41 patients experienced clinical relapse and were reinfused. One patient, who received eight infusions, dropped out of the study because of repeated local infections.
Infliximab treatment can induce antibodies to infliximab, resulting in the possible loss of clinical efficacy, they noted. Due to measurement difficulties, antibody assays were regarded as inconclusive in patients who had detectable serum levels of infliximab. Of the 42 patients, 27 (64.3%) provided blood samples at the time of infliximab withdrawal, and 35 (83.3%) provided blood samples at clinical relapse. High serum levels of infliximab were detected in 24 (88.9%) of the 27 patients who provided blood samples at infliximab withdrawal, while high levels were detected in 18 patients (51.4%) who provided blood samples at clinical relapse.
One patient showed antibodies to infliximab at 6 weeks after withdrawal, despite an initial favorable response during the previous 3-year study, and no clinical relapse until 24 weeks. This patient withdrew from the study after eight infusions because of repeated local infections.
Among the patients who completed the study after infliximab readministration, mean BASDAI scores increased from 2.5 at the time of infliximab withdrawal to 6.0 at the time of clinical relapse. Mean BASDAI scores decreased following infliximab readministration, to mean values of 2.7 at week 24 to 2.6 at week 48. Median C-reactive protein levels increased from 1.0 at infliximab withdrawal to 11.2 at clinical relapse, dropping again after infliximab readministration to 1.6 at week 24 and 1.8 at week 48. Erythrocyte sedimentation rate showed a similar pattern, rising from median levels of 8 at infliximab withdrawal, to 24 at clinical relapse, and decreasing to 6 and 11 at weeks 24 and 48, respectively.
The authors acknowledged receiving research support from Centocor, the manufacturer of Remicade (infliximab).
Infliximab readministration after relapse lowered BASDAI scores, CRP levels, and ESRs. DR. BARALIAKOS
Readministration of infliximab was generally safe and effective in patients with ankylosing spondylitis who had previously discontinued treatment, reported Dr. Xenofon Baraliakos and colleagues.
Dr. Baraliakos, of Rheumazentrum Ruhrgebiet in Herne, Germany, and colleagues designed a study to evaluate the safety and efficacy of infliximab readministration in patients with ankylosing spondylitis who experienced clinical relapse following infliximab withdrawal (J. Rheumatol. 2007 Feb. 1; [Epub ahead of print]). The study population consisted of 42 patients with ankylosing spondylitis who had completed a 3-year, open-label extension study of continuous infliximab therapy administered by infusion at a dose of 5 mg/kg every 6 weeks.
Patients discontinued infliximab at the end of the third year of the open-label extension study. The date of infliximab withdrawal was defined as timepoint (TP) 1. Patients were assessed every 6 weeks after infliximab withdrawal for signs of disease flare, the investigators reported. Clinical relapse was defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater and a physician's global assessment score of 4 or greater. Patients who experienced clinical relapse were reinfused with infliximab at a dose of 5 mg/kg. The time of clinical relapse was defined as TP2.
Patients were reinfused every 6 weeks after TP2 for the duration of the study. Clinical data were obtained at each visit throughout the study. Study-specific data were collected at the time of infliximab withdrawal, at the time of clinical relapse, and at 24 and 48 weeks after TP2.
Of the 42 patients who enrolled in the study, one remained in clinical remission 48 weeks after infliximab withdrawal, the investigators noted. The remaining 41 patients experienced clinical relapse and were reinfused. One patient, who received eight infusions, dropped out of the study because of repeated local infections.
Infliximab treatment can induce antibodies to infliximab, resulting in the possible loss of clinical efficacy, they noted. Due to measurement difficulties, antibody assays were regarded as inconclusive in patients who had detectable serum levels of infliximab. Of the 42 patients, 27 (64.3%) provided blood samples at the time of infliximab withdrawal, and 35 (83.3%) provided blood samples at clinical relapse. High serum levels of infliximab were detected in 24 (88.9%) of the 27 patients who provided blood samples at infliximab withdrawal, while high levels were detected in 18 patients (51.4%) who provided blood samples at clinical relapse.
One patient showed antibodies to infliximab at 6 weeks after withdrawal, despite an initial favorable response during the previous 3-year study, and no clinical relapse until 24 weeks. This patient withdrew from the study after eight infusions because of repeated local infections.
Among the patients who completed the study after infliximab readministration, mean BASDAI scores increased from 2.5 at the time of infliximab withdrawal to 6.0 at the time of clinical relapse. Mean BASDAI scores decreased following infliximab readministration, to mean values of 2.7 at week 24 to 2.6 at week 48. Median C-reactive protein levels increased from 1.0 at infliximab withdrawal to 11.2 at clinical relapse, dropping again after infliximab readministration to 1.6 at week 24 and 1.8 at week 48. Erythrocyte sedimentation rate showed a similar pattern, rising from median levels of 8 at infliximab withdrawal, to 24 at clinical relapse, and decreasing to 6 and 11 at weeks 24 and 48, respectively.
The authors acknowledged receiving research support from Centocor, the manufacturer of Remicade (infliximab).
Infliximab readministration after relapse lowered BASDAI scores, CRP levels, and ESRs. DR. BARALIAKOS
Readministration of infliximab was generally safe and effective in patients with ankylosing spondylitis who had previously discontinued treatment, reported Dr. Xenofon Baraliakos and colleagues.
Dr. Baraliakos, of Rheumazentrum Ruhrgebiet in Herne, Germany, and colleagues designed a study to evaluate the safety and efficacy of infliximab readministration in patients with ankylosing spondylitis who experienced clinical relapse following infliximab withdrawal (J. Rheumatol. 2007 Feb. 1; [Epub ahead of print]). The study population consisted of 42 patients with ankylosing spondylitis who had completed a 3-year, open-label extension study of continuous infliximab therapy administered by infusion at a dose of 5 mg/kg every 6 weeks.
Patients discontinued infliximab at the end of the third year of the open-label extension study. The date of infliximab withdrawal was defined as timepoint (TP) 1. Patients were assessed every 6 weeks after infliximab withdrawal for signs of disease flare, the investigators reported. Clinical relapse was defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or greater and a physician's global assessment score of 4 or greater. Patients who experienced clinical relapse were reinfused with infliximab at a dose of 5 mg/kg. The time of clinical relapse was defined as TP2.
Patients were reinfused every 6 weeks after TP2 for the duration of the study. Clinical data were obtained at each visit throughout the study. Study-specific data were collected at the time of infliximab withdrawal, at the time of clinical relapse, and at 24 and 48 weeks after TP2.
Of the 42 patients who enrolled in the study, one remained in clinical remission 48 weeks after infliximab withdrawal, the investigators noted. The remaining 41 patients experienced clinical relapse and were reinfused. One patient, who received eight infusions, dropped out of the study because of repeated local infections.
Infliximab treatment can induce antibodies to infliximab, resulting in the possible loss of clinical efficacy, they noted. Due to measurement difficulties, antibody assays were regarded as inconclusive in patients who had detectable serum levels of infliximab. Of the 42 patients, 27 (64.3%) provided blood samples at the time of infliximab withdrawal, and 35 (83.3%) provided blood samples at clinical relapse. High serum levels of infliximab were detected in 24 (88.9%) of the 27 patients who provided blood samples at infliximab withdrawal, while high levels were detected in 18 patients (51.4%) who provided blood samples at clinical relapse.
One patient showed antibodies to infliximab at 6 weeks after withdrawal, despite an initial favorable response during the previous 3-year study, and no clinical relapse until 24 weeks. This patient withdrew from the study after eight infusions because of repeated local infections.
Among the patients who completed the study after infliximab readministration, mean BASDAI scores increased from 2.5 at the time of infliximab withdrawal to 6.0 at the time of clinical relapse. Mean BASDAI scores decreased following infliximab readministration, to mean values of 2.7 at week 24 to 2.6 at week 48. Median C-reactive protein levels increased from 1.0 at infliximab withdrawal to 11.2 at clinical relapse, dropping again after infliximab readministration to 1.6 at week 24 and 1.8 at week 48. Erythrocyte sedimentation rate showed a similar pattern, rising from median levels of 8 at infliximab withdrawal, to 24 at clinical relapse, and decreasing to 6 and 11 at weeks 24 and 48, respectively.
The authors acknowledged receiving research support from Centocor, the manufacturer of Remicade (infliximab).
Infliximab readministration after relapse lowered BASDAI scores, CRP levels, and ESRs. DR. BARALIAKOS
Molecular Weight Guides Hyaluronic Acid Choice
SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.
Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.
The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).
On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).
Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.
Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.
Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.
SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.
Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.
The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).
On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).
Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.
Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.
Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.
SAN FRANCISCO — Because there are at least six commercial products available for viscosupplementation with hyaluronic acid, it can be hard to determine which to use, according to Dr. Anthony Luke, who provided tips and clinical pearls at a conference on sports medicine sponsored by the University of California, San Francisco.
Viscosupplementation with hyaluronic acid derivatives is FDA approved for treatment for mild knee osteoarthritis. However, available hyaluronic acid products differ in molecular weight, concentration, and suggested dosing, said Dr. Luke of the university.
The molecular weight of hyaluronic acid in synovial fluid is 6,000–7,000 kd, so one would expect that products at 6,000 kd, the closest in molecular weight to the natural substance, might perform best, Dr. Luke said. However, one study suggests that high-molecular weight injections result in better pain relief than low-molecular weight injections (Clin. Ther. 1999;21:1549–62), and another determined that the effect of hyaluronic acid on osteoblasts increased with molecular weight (Bone 2003;33:703–10).
On the other hand, low-molecular weight preparations may achieve higher concentrations in the desired tissue, he said. A recently published randomized controlled trial demonstrated that two hyaluronic acid preparations of different molecular weights were both more effective than placebo, but there was no statistically significant difference between them (Rheumatol. Int. 2006;26:325–30).
Studies have shown that viscosupplementation is similar to steroid injections in success in reducing pain in mild osteoarthritis, he said. But viscosupplementation appears to have a more prolonged effect than corticosteroids.
Dr. Luke said that he prefers a superolateral approach with a 1.5-inch needle, finding it to be more accurate than the bent-knee approach. If the patient's knee has an effusion, it should first be drained with a 22-gauge needle to avoid diluting the hyaluronic acid.
Dr. Luke said that he occasionally uses the treatment in patients with severe osteoarthritis of the knee who can't take steroids.