Rheumatoid Arthritis

LONDON – Hypothyroidism is prevalent in patients with inflammatory arthritis and is associated with increased cardiovascular risk, according to the findings of a large, primary care practice study.

The prevalence of hypothyroidism in Dutch women with inflammatory arthritis (IA) was 6.5% vs. 3.9% (P less than .0005) for those without. Corresponding figures in Dutch men were 2.4% and 0.8%, respectively (P less than .0005), according to results presented at the annual European Congress of Rheumatology.

Hypothyroidism and IA were each found to independently increase the risk of cardiovascular disease (CVD) in women, compared with women who had neither disease. Women with both conditions had more than three times the risk for CVD, compared with controls.

The findings highlight the need for primary care providers to be aware of the link between hypothyroidism and IA, suggested Dr. Hennie Raterman of the Free University Medical Center in Amsterdam.

"In inflammatory arthritis patients, you see a high coexistence of cardiovascular risk factors and cardiovascular diseases such as acute myocardial infarction and stroke," Dr. Raterman said in an interview. "On top of that, and if you have the coexistence of the two autoimmune diseases [IA and hypothyroidism], the risk is further amplified."

General practitioners act as the gatekeepers to specialist health care services in the Netherlands, and are therefore well placed to provide information about the prevalence of comorbid disease, Dr. Raterman observed.

The cross-sectional study involved the examination of electronic medical records from approximately 175,000 patients who were seen at 96 general practice clinics in the Netherlands up until 2006. IA was identified in 1,518 patients; this included patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondyloarthritis.

The overall prevalence of hypothyroidism was 5% (n = 76/1,518) in patients with IA vs. 2.3% (n = 4,153/173,543) in those without IA in the general practice population (P less than .0005).

As hypothyroidism was found to be most prevalent in women with IA, and the number of men (n = 13) included in the sample with IA was too low to achieve statistical power, the second part of the study focused on CVD risk in female patients only.

After adjustment for age and the presence of diabetes, hypertension and hypercholesterolemia, the odds ratios for the development of CVD relative to controls was 1.19 for women with hypothyroidism, 1.48 for those with IA, and 3.72 for those with both autoimmune diseases.

In the treatment of patients with comorbid IA and hypothyroidism, Dr. Raterman said that it was important to keep both conditions well controlled.

Diabetes is another autoimmune condition that may cluster in patients with IA and hypothyroidism, so paying attention to that disease may also prove important. Perhaps treating one autoimmune disease will improve the outcome of other comorbid conditions, he suggested.

Dr. Raterman and colleagues recently demonstrated that the use of anti–tumor necrosis factor-alpha therapy in patients with rheumatoid arthritis and hypothyroidism can improve thyroid function (J. Rheumatol. 2011;38:247-51).

Keeping the arthritis and the thyroid disease well controlled may be enough to address the already high risk for CVD in patients with one or the other, or both autoimmune diseases, but "when that’s not enough I think you have to target all the cardiovascular risk factors."

Dr. Raterman reported that he had no relevant conflicts of interest.

LONDON – Hypothyroidism is prevalent in patients with inflammatory arthritis and is associated with increased cardiovascular risk, according to the findings of a large, primary care practice study.

The prevalence of hypothyroidism in Dutch women with inflammatory arthritis (IA) was 6.5% vs. 3.9% (P less than .0005) for those without. Corresponding figures in Dutch men were 2.4% and 0.8%, respectively (P less than .0005), according to results presented at the annual European Congress of Rheumatology.

Hypothyroidism and IA were each found to independently increase the risk of cardiovascular disease (CVD) in women, compared with women who had neither disease. Women with both conditions had more than three times the risk for CVD, compared with controls.

The findings highlight the need for primary care providers to be aware of the link between hypothyroidism and IA, suggested Dr. Hennie Raterman of the Free University Medical Center in Amsterdam.

"In inflammatory arthritis patients, you see a high coexistence of cardiovascular risk factors and cardiovascular diseases such as acute myocardial infarction and stroke," Dr. Raterman said in an interview. "On top of that, and if you have the coexistence of the two autoimmune diseases [IA and hypothyroidism], the risk is further amplified."

General practitioners act as the gatekeepers to specialist health care services in the Netherlands, and are therefore well placed to provide information about the prevalence of comorbid disease, Dr. Raterman observed.

The cross-sectional study involved the examination of electronic medical records from approximately 175,000 patients who were seen at 96 general practice clinics in the Netherlands up until 2006. IA was identified in 1,518 patients; this included patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondyloarthritis.

The overall prevalence of hypothyroidism was 5% (n = 76/1,518) in patients with IA vs. 2.3% (n = 4,153/173,543) in those without IA in the general practice population (P less than .0005).

As hypothyroidism was found to be most prevalent in women with IA, and the number of men (n = 13) included in the sample with IA was too low to achieve statistical power, the second part of the study focused on CVD risk in female patients only.

After adjustment for age and the presence of diabetes, hypertension and hypercholesterolemia, the odds ratios for the development of CVD relative to controls was 1.19 for women with hypothyroidism, 1.48 for those with IA, and 3.72 for those with both autoimmune diseases.

In the treatment of patients with comorbid IA and hypothyroidism, Dr. Raterman said that it was important to keep both conditions well controlled.

Diabetes is another autoimmune condition that may cluster in patients with IA and hypothyroidism, so paying attention to that disease may also prove important. Perhaps treating one autoimmune disease will improve the outcome of other comorbid conditions, he suggested.

Dr. Raterman and colleagues recently demonstrated that the use of anti–tumor necrosis factor-alpha therapy in patients with rheumatoid arthritis and hypothyroidism can improve thyroid function (J. Rheumatol. 2011;38:247-51).

Keeping the arthritis and the thyroid disease well controlled may be enough to address the already high risk for CVD in patients with one or the other, or both autoimmune diseases, but "when that’s not enough I think you have to target all the cardiovascular risk factors."

Dr. Raterman reported that he had no relevant conflicts of interest.

LONDON – Hypothyroidism is prevalent in patients with inflammatory arthritis and is associated with increased cardiovascular risk, according to the findings of a large, primary care practice study.

The prevalence of hypothyroidism in Dutch women with inflammatory arthritis (IA) was 6.5% vs. 3.9% (P less than .0005) for those without. Corresponding figures in Dutch men were 2.4% and 0.8%, respectively (P less than .0005), according to results presented at the annual European Congress of Rheumatology.

Hypothyroidism and IA were each found to independently increase the risk of cardiovascular disease (CVD) in women, compared with women who had neither disease. Women with both conditions had more than three times the risk for CVD, compared with controls.

The findings highlight the need for primary care providers to be aware of the link between hypothyroidism and IA, suggested Dr. Hennie Raterman of the Free University Medical Center in Amsterdam.

"In inflammatory arthritis patients, you see a high coexistence of cardiovascular risk factors and cardiovascular diseases such as acute myocardial infarction and stroke," Dr. Raterman said in an interview. "On top of that, and if you have the coexistence of the two autoimmune diseases [IA and hypothyroidism], the risk is further amplified."

General practitioners act as the gatekeepers to specialist health care services in the Netherlands, and are therefore well placed to provide information about the prevalence of comorbid disease, Dr. Raterman observed.

The cross-sectional study involved the examination of electronic medical records from approximately 175,000 patients who were seen at 96 general practice clinics in the Netherlands up until 2006. IA was identified in 1,518 patients; this included patients with a diagnosis of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondyloarthritis.

The overall prevalence of hypothyroidism was 5% (n = 76/1,518) in patients with IA vs. 2.3% (n = 4,153/173,543) in those without IA in the general practice population (P less than .0005).

As hypothyroidism was found to be most prevalent in women with IA, and the number of men (n = 13) included in the sample with IA was too low to achieve statistical power, the second part of the study focused on CVD risk in female patients only.

After adjustment for age and the presence of diabetes, hypertension and hypercholesterolemia, the odds ratios for the development of CVD relative to controls was 1.19 for women with hypothyroidism, 1.48 for those with IA, and 3.72 for those with both autoimmune diseases.

In the treatment of patients with comorbid IA and hypothyroidism, Dr. Raterman said that it was important to keep both conditions well controlled.

Diabetes is another autoimmune condition that may cluster in patients with IA and hypothyroidism, so paying attention to that disease may also prove important. Perhaps treating one autoimmune disease will improve the outcome of other comorbid conditions, he suggested.

Dr. Raterman and colleagues recently demonstrated that the use of anti–tumor necrosis factor-alpha therapy in patients with rheumatoid arthritis and hypothyroidism can improve thyroid function (J. Rheumatol. 2011;38:247-51).

Keeping the arthritis and the thyroid disease well controlled may be enough to address the already high risk for CVD in patients with one or the other, or both autoimmune diseases, but "when that’s not enough I think you have to target all the cardiovascular risk factors."

Dr. Raterman reported that he had no relevant conflicts of interest.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614-8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor’s note, the CDC report observed: "Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity."

Dr. Barbour said that numerous barriers involved in arthritis can hinder people’s ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient’s full range of difficulties when making recommendations to engage in exercise, he added.

"We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers]."

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614-8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor’s note, the CDC report observed: "Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity."

Dr. Barbour said that numerous barriers involved in arthritis can hinder people’s ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient’s full range of difficulties when making recommendations to engage in exercise, he added.

"We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers]."

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614-8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor’s note, the CDC report observed: "Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity."

Dr. Barbour said that numerous barriers involved in arthritis can hinder people’s ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient’s full range of difficulties when making recommendations to engage in exercise, he added.

"We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers]."

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614–8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor's note, the CDC report observed: “Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity.”

Dr. Barbour said that numerous barriers involved in arthritis can hinder people's ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient's full range of difficulties when making recommendations to engage in exercise, he added.

“We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers].”

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614–8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor's note, the CDC report observed: “Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity.”

Dr. Barbour said that numerous barriers involved in arthritis can hinder people's ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient's full range of difficulties when making recommendations to engage in exercise, he added.

“We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers].”

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

Obesity makes it even less likely that a patient with arthritis is going to exercise, according to findings from two surveys conducted by the Centers for Disease Control and Prevention.

Arthritis is a common comorbidity of obesity. Approximately one-third (35.6%) of adults with self-reported obesity were also affected by physician-diagnosed arthritis, judging from the combined results of the surveys, which were performed in 2007 and 2009.

The combination of arthritis and obesity resulted in a more sedentary lifestyle: 22.7% of obese adults with arthritis were physically inactive, compared with 16.1% with arthritis alone, 13.5% with obesity alone, and 9.4% with neither condition (MMWR 2011;60:614–8).

The state-based, random-digit–dialed telephone survey included a total of 789,460 adults from 50 states, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands. These surveys are part of a series conducted by the CDC to examine the affects of arthritis and comorbid conditions. Previous studies looked at arthritis comorbidity with diabetes and heart disease. CDC researcher Kamil Barbour, Ph.D., said in an interview that results show that patients with chronic conditions are less likely to be physically active if they also have arthritis.

In an editor's note, the CDC report observed: “Arthritis and obesity are common chronic conditions affecting an estimated 50 million and 72 million U.S. adults, respectively. The findings in this report indicate that these conditions co-occur commonly (one in three adults with obesity also has arthritis) and might hinder the management of both conditions by limiting physical activity. Among adults with both obesity and arthritis, the adjusted likelihood of physical inactivity was 44% higher compared with that of adults with obesity but without arthritis; all state-specific estimates were consistent with these results. These findings suggest that among many persons with obesity, arthritis might be an additional barrier to physical activity.”

Dr. Barbour said that numerous barriers involved in arthritis can hinder people's ability to be active, beyond just being obese. The findings of these surveys should encourage doctors to consider the patient's full range of difficulties when making recommendations to engage in exercise, he added.

“We want to make [physicians] aware that they should look beyond obesity and any of the current conditions that [patients] may have, and look at the arthritis-specific barriers and kind of tailor their interventions toward addressing these [barriers].”

Dr. Barbour said the CDC will be using this information to augment community physical activity programs through the CDC Arthritis Program. The programs include EnhanceFitness, the Arthritis Foundation Exercise Program, and the Arthritis Foundation Walk With Ease programs, as well as self-management education programs.

Dr. Barbour and the other researchers who conducted and reported the study all work for the CDC.

A newly developed evidence-based set of recommendations and an algorithm for pharmacotherapy-based pain management in inflammatory arthritis achieved a high level of agreement among a multinational panel of rheumatologists who constitute the 2010 3e Initiative, according to Dr. Samuel Whittle.

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology.

For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

Based on a systematic literature review performed for each question – ultimately including data from 167 relevant studies – rheumatologists from each country that was represented developed a set of national recommendations, and then multinational recommendations were formulated and assessed for agreement, reported Dr. Whittle of the Queen Elizabeth Hospital near Adelaide, Australia.

The panel made 11 recommendations in total. One of the original 10 questions was addressed by two separate systematic reviews. Six of the recommendations address the role of different analgesic medications, including combination therapy; two address pain-medication safety in patients with gastrointestinal, hepatic, renal, and cardiac comorbidities; one addresses pain measurement scales; one addresses pain management during the preconception period, pregnancy, and lactation; and one addresses the safety of analgesics in combination with methotrexate.

The level of agreement on the recommendations by the panel members ranged from 8.5 to 9.3 (mean, 8.9) on a 1- to 10-point scale.

“Although this level of agreement is quite high, it is not a particularly surprising finding,” said Dr. Alexandra Colebatch, one of the authors of the report. Previous recommendations from the 3e initiative have had a mean level of agreement of 8.7 (range, 7.4–9.1) (Ann. Rheum. Dis. 2011;70:15–24) and 8.7 (range, 7.8–9.4) (Ann. Rheum. Dis. 2011;70:388–9).

As for the algorithm developed for the pharmacologic management of pain, most (75%) of the rheumatologists said it was in accordance with their current practice, whereas 20% reported that it would change their practice, according to Dr. Whittle.

In addition to the main treatments to use in this patient population, the algorithm lists several points to consider, including type of pain, residual inflammation, comorbidities, patient preference, and addictive potential, and also includes adjuvant therapeutic options (such as tricyclic antidepressants and neuromodulators) to consider in these patients.

The evidence-based nature of these recommendations and the related algorithm, as well as the level of support demonstrated by the 3e initiative panel, suggest that they will have great utility in clinical practice, he concluded.

The full recommendations and algorithm paper will be published soon, Dr. Colebatch said; 3e has previously addressed the investigation and follow-up of undifferentiated peripheral IA, and the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis, she noted.

The panel's 11 recommendations for pharmacotherapy pain management in IA are the following:

▸ In patients with IA, pain should be measured routinely using one of the following validated scales: visual analogue scale, numerical rating scale, or verbal rating scale. In addition, consider multidimensional measures or site-specific tools.

▸ Paracetamol is recommended for the treatment of persistent pain in patients with IA.

▸ Systemic glucocorticoids are not recommended for the routine management of pain in patients with IA in the absence of signs and symptoms of inflammation.

▸ In the treatment of pain in IA, tricyclic antidepressants and neuromodulators may be considered for use as adjuvant treatment; muscle relaxants and benzodiazepines aren't recommended.

▸ Weak opioids may be used for short-term treatment of pain in patients with IA when other therapies have failed or are contraindicated; long-term use may be considered and should be regularly reviewed. Strong opioids should be used only in exceptional cases.

▸ In patients with an inadequate response to paracetamol or NSAID monotherapy, the addition of a drug with a different mode of action could be considered; combination of two or more NSAIDs should not be used.

▸ NSAIDs should be used at the lowest effective dose, either continuously or on demand, according to clinical circumstances.

▸ Existing guidance regarding the safety of pain pharmacotherapies during preconception, pregnancy, and lactation should be applied.

▸ In the management of patients with IA, methotrexate can be used safely in combination with standard doses of paracetamol and/or NSAIDs (excluding anti-inflammatory doses of aspirin).

▸ In patients with gastrointestinal comorbidities, paracetamol should be considered first. NSAIDs in combination with proton pump inhibitors (PPI), or coxibs with or without PPI, may be used with caution. In the presence of liver disease, standard precautions for use of NSAIDs and other analgesics should be applied.

▸ In patients with IA plus preexisting hypertension or cardiovascular or renal disease, paracetamol should be used first; NSAIDs (including coxibs) should be used with caution.

The 3e initiative is supported by an unrestricted educational grant from Abbott. Neither Dr. Whittle nor any co-authors on this study had additional disclosures to report.

To watch an interview with Dr. Whittlew, scan this QR code with a smartphone.

Dr. Samuel Whittle discussed the proposed 3e recommendations with senior reporter Heidi Splete.

Source Heidi Splete/Elsevier Global Medical News

A newly developed evidence-based set of recommendations and an algorithm for pharmacotherapy-based pain management in inflammatory arthritis achieved a high level of agreement among a multinational panel of rheumatologists who constitute the 2010 3e Initiative, according to Dr. Samuel Whittle.

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology.

For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

Based on a systematic literature review performed for each question – ultimately including data from 167 relevant studies – rheumatologists from each country that was represented developed a set of national recommendations, and then multinational recommendations were formulated and assessed for agreement, reported Dr. Whittle of the Queen Elizabeth Hospital near Adelaide, Australia.

The panel made 11 recommendations in total. One of the original 10 questions was addressed by two separate systematic reviews. Six of the recommendations address the role of different analgesic medications, including combination therapy; two address pain-medication safety in patients with gastrointestinal, hepatic, renal, and cardiac comorbidities; one addresses pain measurement scales; one addresses pain management during the preconception period, pregnancy, and lactation; and one addresses the safety of analgesics in combination with methotrexate.

The level of agreement on the recommendations by the panel members ranged from 8.5 to 9.3 (mean, 8.9) on a 1- to 10-point scale.

“Although this level of agreement is quite high, it is not a particularly surprising finding,” said Dr. Alexandra Colebatch, one of the authors of the report. Previous recommendations from the 3e initiative have had a mean level of agreement of 8.7 (range, 7.4–9.1) (Ann. Rheum. Dis. 2011;70:15–24) and 8.7 (range, 7.8–9.4) (Ann. Rheum. Dis. 2011;70:388–9).

As for the algorithm developed for the pharmacologic management of pain, most (75%) of the rheumatologists said it was in accordance with their current practice, whereas 20% reported that it would change their practice, according to Dr. Whittle.

In addition to the main treatments to use in this patient population, the algorithm lists several points to consider, including type of pain, residual inflammation, comorbidities, patient preference, and addictive potential, and also includes adjuvant therapeutic options (such as tricyclic antidepressants and neuromodulators) to consider in these patients.

The evidence-based nature of these recommendations and the related algorithm, as well as the level of support demonstrated by the 3e initiative panel, suggest that they will have great utility in clinical practice, he concluded.

The full recommendations and algorithm paper will be published soon, Dr. Colebatch said; 3e has previously addressed the investigation and follow-up of undifferentiated peripheral IA, and the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis, she noted.

The panel's 11 recommendations for pharmacotherapy pain management in IA are the following:

▸ In patients with IA, pain should be measured routinely using one of the following validated scales: visual analogue scale, numerical rating scale, or verbal rating scale. In addition, consider multidimensional measures or site-specific tools.

▸ Paracetamol is recommended for the treatment of persistent pain in patients with IA.

▸ Systemic glucocorticoids are not recommended for the routine management of pain in patients with IA in the absence of signs and symptoms of inflammation.

▸ In the treatment of pain in IA, tricyclic antidepressants and neuromodulators may be considered for use as adjuvant treatment; muscle relaxants and benzodiazepines aren't recommended.

▸ Weak opioids may be used for short-term treatment of pain in patients with IA when other therapies have failed or are contraindicated; long-term use may be considered and should be regularly reviewed. Strong opioids should be used only in exceptional cases.

▸ In patients with an inadequate response to paracetamol or NSAID monotherapy, the addition of a drug with a different mode of action could be considered; combination of two or more NSAIDs should not be used.

▸ NSAIDs should be used at the lowest effective dose, either continuously or on demand, according to clinical circumstances.

▸ Existing guidance regarding the safety of pain pharmacotherapies during preconception, pregnancy, and lactation should be applied.

▸ In the management of patients with IA, methotrexate can be used safely in combination with standard doses of paracetamol and/or NSAIDs (excluding anti-inflammatory doses of aspirin).

▸ In patients with gastrointestinal comorbidities, paracetamol should be considered first. NSAIDs in combination with proton pump inhibitors (PPI), or coxibs with or without PPI, may be used with caution. In the presence of liver disease, standard precautions for use of NSAIDs and other analgesics should be applied.

▸ In patients with IA plus preexisting hypertension or cardiovascular or renal disease, paracetamol should be used first; NSAIDs (including coxibs) should be used with caution.

The 3e initiative is supported by an unrestricted educational grant from Abbott. Neither Dr. Whittle nor any co-authors on this study had additional disclosures to report.

To watch an interview with Dr. Whittlew, scan this QR code with a smartphone.

Dr. Samuel Whittle discussed the proposed 3e recommendations with senior reporter Heidi Splete.

Source Heidi Splete/Elsevier Global Medical News

A newly developed evidence-based set of recommendations and an algorithm for pharmacotherapy-based pain management in inflammatory arthritis achieved a high level of agreement among a multinational panel of rheumatologists who constitute the 2010 3e Initiative, according to Dr. Samuel Whittle.

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology.

For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

Based on a systematic literature review performed for each question – ultimately including data from 167 relevant studies – rheumatologists from each country that was represented developed a set of national recommendations, and then multinational recommendations were formulated and assessed for agreement, reported Dr. Whittle of the Queen Elizabeth Hospital near Adelaide, Australia.

The panel made 11 recommendations in total. One of the original 10 questions was addressed by two separate systematic reviews. Six of the recommendations address the role of different analgesic medications, including combination therapy; two address pain-medication safety in patients with gastrointestinal, hepatic, renal, and cardiac comorbidities; one addresses pain measurement scales; one addresses pain management during the preconception period, pregnancy, and lactation; and one addresses the safety of analgesics in combination with methotrexate.

The level of agreement on the recommendations by the panel members ranged from 8.5 to 9.3 (mean, 8.9) on a 1- to 10-point scale.

“Although this level of agreement is quite high, it is not a particularly surprising finding,” said Dr. Alexandra Colebatch, one of the authors of the report. Previous recommendations from the 3e initiative have had a mean level of agreement of 8.7 (range, 7.4–9.1) (Ann. Rheum. Dis. 2011;70:15–24) and 8.7 (range, 7.8–9.4) (Ann. Rheum. Dis. 2011;70:388–9).

As for the algorithm developed for the pharmacologic management of pain, most (75%) of the rheumatologists said it was in accordance with their current practice, whereas 20% reported that it would change their practice, according to Dr. Whittle.

In addition to the main treatments to use in this patient population, the algorithm lists several points to consider, including type of pain, residual inflammation, comorbidities, patient preference, and addictive potential, and also includes adjuvant therapeutic options (such as tricyclic antidepressants and neuromodulators) to consider in these patients.

The evidence-based nature of these recommendations and the related algorithm, as well as the level of support demonstrated by the 3e initiative panel, suggest that they will have great utility in clinical practice, he concluded.

The full recommendations and algorithm paper will be published soon, Dr. Colebatch said; 3e has previously addressed the investigation and follow-up of undifferentiated peripheral IA, and the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis, she noted.

The panel's 11 recommendations for pharmacotherapy pain management in IA are the following:

▸ In patients with IA, pain should be measured routinely using one of the following validated scales: visual analogue scale, numerical rating scale, or verbal rating scale. In addition, consider multidimensional measures or site-specific tools.

▸ Paracetamol is recommended for the treatment of persistent pain in patients with IA.

▸ Systemic glucocorticoids are not recommended for the routine management of pain in patients with IA in the absence of signs and symptoms of inflammation.

▸ In the treatment of pain in IA, tricyclic antidepressants and neuromodulators may be considered for use as adjuvant treatment; muscle relaxants and benzodiazepines aren't recommended.

▸ Weak opioids may be used for short-term treatment of pain in patients with IA when other therapies have failed or are contraindicated; long-term use may be considered and should be regularly reviewed. Strong opioids should be used only in exceptional cases.

▸ In patients with an inadequate response to paracetamol or NSAID monotherapy, the addition of a drug with a different mode of action could be considered; combination of two or more NSAIDs should not be used.

▸ NSAIDs should be used at the lowest effective dose, either continuously or on demand, according to clinical circumstances.

▸ Existing guidance regarding the safety of pain pharmacotherapies during preconception, pregnancy, and lactation should be applied.

▸ In the management of patients with IA, methotrexate can be used safely in combination with standard doses of paracetamol and/or NSAIDs (excluding anti-inflammatory doses of aspirin).

▸ In patients with gastrointestinal comorbidities, paracetamol should be considered first. NSAIDs in combination with proton pump inhibitors (PPI), or coxibs with or without PPI, may be used with caution. In the presence of liver disease, standard precautions for use of NSAIDs and other analgesics should be applied.

▸ In patients with IA plus preexisting hypertension or cardiovascular or renal disease, paracetamol should be used first; NSAIDs (including coxibs) should be used with caution.

The 3e initiative is supported by an unrestricted educational grant from Abbott. Neither Dr. Whittle nor any co-authors on this study had additional disclosures to report.

To watch an interview with Dr. Whittlew, scan this QR code with a smartphone.

Dr. Samuel Whittle discussed the proposed 3e recommendations with senior reporter Heidi Splete.

Source Heidi Splete/Elsevier Global Medical News

Major Finding: The incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient-years).

Data Source: Retrospective study of 143,433 patients with rheumatoid arthritis with at least two nondiagnostic claims in a U.S. administrative database filed between 2001 and 2009.

Disclosures: Dr. Curtis disclosed research and consulting relationships with Abbot, Amgen, BMS, Centocor, CORRONA, Crescendo, Pfizer, Roche, and UCB.

LONDON – Although a potentially serious complication, perforation of the gastrointestinal tract is rare, judging from the findings of an analysis of more than 140,000 patients with rheumatoid arthritis.

Upper or lower GI tract perforation occurred in 696 (0.5%) of patients, with an overall, unadjusted incidence rate of 1.7 cases per 1,000 person-years, according to Dr. Jeffrey Curtis. “For [most of] the rheumatoid arthritis patients someone has in their practice, [GI perforation] is going to be very uncommon, I think that should be reassuring,” he said during an interview.

“We also observed that there were cases [of GI perforation] for every biologic group,” added Dr. Curtis, a rheumatologist, epidemiologist, and associate professor of medicine at the University of Alabama at Birmingham. This should help dispel any concerns that the adverse event might occur with certain biologic agents used to treat RA, he suggested.

In a retrospective study, Dr. Curtis and his associates analyzed records of 143,433 RA patients from a large U.S.-based administrative claims database for the years 2001–2009. The investigators used a validated algorithm to identify cases of upper and lower GI perforation and to determine predictive factors. The median follow-up was 2.5 years.

Older age was found to be a predictor of GI perforation, with adjusted relative risks of 1.6 and 2.1 for people aged 40–64 years and 65 years, respectively, compared with RA patients younger than 40 years. The mean age of the 142,737 patients who did not have a GI perforation was 57.6 years, and the mean age of the 696 patients who did was 62 years (P less than .01).

Diverticulitis and diverticulosis without diverticulitis were also significantly more common in patients who experienced a GI perforation than in those who did not, although the incidence was still low, with rates of 2.9% vs. 0.3% and 1.4% vs. 0.4%, respectively (both P less than .01). Diverticulitis but not diverticulosis was a significant risk factor for perforation. The main risk factors among the RA medication groups of most relevance were the use of oral glucocorticosteroids and nonsteroidal anti-inflammatory drugs, not biologics and not the disease-modifying antirheumatic drugs, he said. Indeed, the incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient years).

Steroid monotherapy carried an incidence of 2.86 per 1,000 patient-years. Steroids used in combination with methotrexate and biologics also increased the risk of the GI complications (2.24 and 1.87 per 1,000 patient-years, respectively).

The rates of GI perforations in patients treated with biologics, methotrexate, or other DMARDs without steroids were 1.02, 1.08, and 1.71 per 1,000 patient-years, respectively. NSAID use was associated with an incidence rate of 1.68 per 1,000 patient-years.

In the study, 80% of the perforations seen were in the lower GI tract, so the use of gastroprotective medications may not be that useful.

Although still important, upper GI bleeding and peptic ulcer disease are perhaps less critical than antecedent diverticulitis and its associated complications.

Minimization of NSAID and steroid use is probably warranted in higher-risk patients, Dr. Curtis advised. “In somebody with a history of diverticulitis, I would be very cautious.”

Major Finding: The incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient-years).

Data Source: Retrospective study of 143,433 patients with rheumatoid arthritis with at least two nondiagnostic claims in a U.S. administrative database filed between 2001 and 2009.

Disclosures: Dr. Curtis disclosed research and consulting relationships with Abbot, Amgen, BMS, Centocor, CORRONA, Crescendo, Pfizer, Roche, and UCB.

LONDON – Although a potentially serious complication, perforation of the gastrointestinal tract is rare, judging from the findings of an analysis of more than 140,000 patients with rheumatoid arthritis.

Upper or lower GI tract perforation occurred in 696 (0.5%) of patients, with an overall, unadjusted incidence rate of 1.7 cases per 1,000 person-years, according to Dr. Jeffrey Curtis. “For [most of] the rheumatoid arthritis patients someone has in their practice, [GI perforation] is going to be very uncommon, I think that should be reassuring,” he said during an interview.

“We also observed that there were cases [of GI perforation] for every biologic group,” added Dr. Curtis, a rheumatologist, epidemiologist, and associate professor of medicine at the University of Alabama at Birmingham. This should help dispel any concerns that the adverse event might occur with certain biologic agents used to treat RA, he suggested.

In a retrospective study, Dr. Curtis and his associates analyzed records of 143,433 RA patients from a large U.S.-based administrative claims database for the years 2001–2009. The investigators used a validated algorithm to identify cases of upper and lower GI perforation and to determine predictive factors. The median follow-up was 2.5 years.

Older age was found to be a predictor of GI perforation, with adjusted relative risks of 1.6 and 2.1 for people aged 40–64 years and 65 years, respectively, compared with RA patients younger than 40 years. The mean age of the 142,737 patients who did not have a GI perforation was 57.6 years, and the mean age of the 696 patients who did was 62 years (P less than .01).

Diverticulitis and diverticulosis without diverticulitis were also significantly more common in patients who experienced a GI perforation than in those who did not, although the incidence was still low, with rates of 2.9% vs. 0.3% and 1.4% vs. 0.4%, respectively (both P less than .01). Diverticulitis but not diverticulosis was a significant risk factor for perforation. The main risk factors among the RA medication groups of most relevance were the use of oral glucocorticosteroids and nonsteroidal anti-inflammatory drugs, not biologics and not the disease-modifying antirheumatic drugs, he said. Indeed, the incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient years).

Steroid monotherapy carried an incidence of 2.86 per 1,000 patient-years. Steroids used in combination with methotrexate and biologics also increased the risk of the GI complications (2.24 and 1.87 per 1,000 patient-years, respectively).

The rates of GI perforations in patients treated with biologics, methotrexate, or other DMARDs without steroids were 1.02, 1.08, and 1.71 per 1,000 patient-years, respectively. NSAID use was associated with an incidence rate of 1.68 per 1,000 patient-years.

In the study, 80% of the perforations seen were in the lower GI tract, so the use of gastroprotective medications may not be that useful.

Although still important, upper GI bleeding and peptic ulcer disease are perhaps less critical than antecedent diverticulitis and its associated complications.

Minimization of NSAID and steroid use is probably warranted in higher-risk patients, Dr. Curtis advised. “In somebody with a history of diverticulitis, I would be very cautious.”

Major Finding: The incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient-years).

Data Source: Retrospective study of 143,433 patients with rheumatoid arthritis with at least two nondiagnostic claims in a U.S. administrative database filed between 2001 and 2009.

Disclosures: Dr. Curtis disclosed research and consulting relationships with Abbot, Amgen, BMS, Centocor, CORRONA, Crescendo, Pfizer, Roche, and UCB.

LONDON – Although a potentially serious complication, perforation of the gastrointestinal tract is rare, judging from the findings of an analysis of more than 140,000 patients with rheumatoid arthritis.

Upper or lower GI tract perforation occurred in 696 (0.5%) of patients, with an overall, unadjusted incidence rate of 1.7 cases per 1,000 person-years, according to Dr. Jeffrey Curtis. “For [most of] the rheumatoid arthritis patients someone has in their practice, [GI perforation] is going to be very uncommon, I think that should be reassuring,” he said during an interview.

“We also observed that there were cases [of GI perforation] for every biologic group,” added Dr. Curtis, a rheumatologist, epidemiologist, and associate professor of medicine at the University of Alabama at Birmingham. This should help dispel any concerns that the adverse event might occur with certain biologic agents used to treat RA, he suggested.

In a retrospective study, Dr. Curtis and his associates analyzed records of 143,433 RA patients from a large U.S.-based administrative claims database for the years 2001–2009. The investigators used a validated algorithm to identify cases of upper and lower GI perforation and to determine predictive factors. The median follow-up was 2.5 years.

Older age was found to be a predictor of GI perforation, with adjusted relative risks of 1.6 and 2.1 for people aged 40–64 years and 65 years, respectively, compared with RA patients younger than 40 years. The mean age of the 142,737 patients who did not have a GI perforation was 57.6 years, and the mean age of the 696 patients who did was 62 years (P less than .01).

Diverticulitis and diverticulosis without diverticulitis were also significantly more common in patients who experienced a GI perforation than in those who did not, although the incidence was still low, with rates of 2.9% vs. 0.3% and 1.4% vs. 0.4%, respectively (both P less than .01). Diverticulitis but not diverticulosis was a significant risk factor for perforation. The main risk factors among the RA medication groups of most relevance were the use of oral glucocorticosteroids and nonsteroidal anti-inflammatory drugs, not biologics and not the disease-modifying antirheumatic drugs, he said. Indeed, the incidence of GI perforation was highest in patients who used glucocorticoids in combination with DMARDs other than methotrexate (3.03 per 1,000 patient years).

Steroid monotherapy carried an incidence of 2.86 per 1,000 patient-years. Steroids used in combination with methotrexate and biologics also increased the risk of the GI complications (2.24 and 1.87 per 1,000 patient-years, respectively).

The rates of GI perforations in patients treated with biologics, methotrexate, or other DMARDs without steroids were 1.02, 1.08, and 1.71 per 1,000 patient-years, respectively. NSAID use was associated with an incidence rate of 1.68 per 1,000 patient-years.

In the study, 80% of the perforations seen were in the lower GI tract, so the use of gastroprotective medications may not be that useful.

Although still important, upper GI bleeding and peptic ulcer disease are perhaps less critical than antecedent diverticulitis and its associated complications.

Minimization of NSAID and steroid use is probably warranted in higher-risk patients, Dr. Curtis advised. “In somebody with a history of diverticulitis, I would be very cautious.”

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

SAN DIEGO – Pain management alternatives to opioids continue to evolve, said Joseph F. Dasta, M.Sc. (Pharm.).

New options include intravenous ibuprofen, approved in June 2009; nasal ketorolac (May 2010); and intravenous acetaminophen, (November 2010).

Nonopioid alternatives are needed because data “suggest that opioids as well as untreated pain are associated with development of postoperative delirium,” said Mr. Dasta, a health care consultant who is also with the College of Pharmacy at the University of Texas, Austin.

Most of the available agents for pain management are short acting, “which can be good and bad,” Mr. Dasta said. In addition, many of the currently approved agents for pain management require intravenous administration and may cause adverse drug reactions.

Intravenous diclofenac is currently being investigated as another possible therapy, he said, as are the cyclo-oxygenase-2 selective inhibitors etoricoxib and parecoxib, and the NSAID lornoxicam.

New studies of bupivacaine, an anesthetic drug that lasts for 6–10 hours, are also underway. “Several formulations are being developed whereby bupivacaine would be instilled into the surgical site, to the operative area, and last for several days,” said Mr. Dasta, who is a paid consultant for Cadence, Hospira, and Pacira Pharmaceuticals.

SAN DIEGO – Pain management alternatives to opioids continue to evolve, said Joseph F. Dasta, M.Sc. (Pharm.).

New options include intravenous ibuprofen, approved in June 2009; nasal ketorolac (May 2010); and intravenous acetaminophen, (November 2010).

Nonopioid alternatives are needed because data “suggest that opioids as well as untreated pain are associated with development of postoperative delirium,” said Mr. Dasta, a health care consultant who is also with the College of Pharmacy at the University of Texas, Austin.

Most of the available agents for pain management are short acting, “which can be good and bad,” Mr. Dasta said. In addition, many of the currently approved agents for pain management require intravenous administration and may cause adverse drug reactions.

Intravenous diclofenac is currently being investigated as another possible therapy, he said, as are the cyclo-oxygenase-2 selective inhibitors etoricoxib and parecoxib, and the NSAID lornoxicam.

New studies of bupivacaine, an anesthetic drug that lasts for 6–10 hours, are also underway. “Several formulations are being developed whereby bupivacaine would be instilled into the surgical site, to the operative area, and last for several days,” said Mr. Dasta, who is a paid consultant for Cadence, Hospira, and Pacira Pharmaceuticals.

SAN DIEGO – Pain management alternatives to opioids continue to evolve, said Joseph F. Dasta, M.Sc. (Pharm.).

New options include intravenous ibuprofen, approved in June 2009; nasal ketorolac (May 2010); and intravenous acetaminophen, (November 2010).

Nonopioid alternatives are needed because data “suggest that opioids as well as untreated pain are associated with development of postoperative delirium,” said Mr. Dasta, a health care consultant who is also with the College of Pharmacy at the University of Texas, Austin.

Most of the available agents for pain management are short acting, “which can be good and bad,” Mr. Dasta said. In addition, many of the currently approved agents for pain management require intravenous administration and may cause adverse drug reactions.

Intravenous diclofenac is currently being investigated as another possible therapy, he said, as are the cyclo-oxygenase-2 selective inhibitors etoricoxib and parecoxib, and the NSAID lornoxicam.

New studies of bupivacaine, an anesthetic drug that lasts for 6–10 hours, are also underway. “Several formulations are being developed whereby bupivacaine would be instilled into the surgical site, to the operative area, and last for several days,” said Mr. Dasta, who is a paid consultant for Cadence, Hospira, and Pacira Pharmaceuticals.

Magnetic resonance imaging is at least as sensitive as other modalities at predicting treatment response in patients with new-onset spondyloarthritis, according to data presented by Dr. Mikkel Østergaard.

In discussing research that pointed to the usefulness of MRI in managing patients with spondyloarthritis (SpA), Dr. Østergaard reviewed the varied manifestations SpA can take on MRI, and how imaging can be a useful tool for predicting the formation of new bone.

“MRI has brought a major improvement in the evaluation and management of patients with spondyloarthritis,” he said. “It allows earlier detection of sacroiliitis than [does] any other modality, and has thereby enabled physicians to diagnose spondyloarthritis up to 5-10 years earlier than they could before.” He added that MRI provides physicians with an objective way to monitor disease activity in SpA.

Dr. Østergaard explained how to use MRI to identify disease in the sacroiliac joints, the spine, and the peripheral joints. “Given the major improvement in evaluation and management of spondyloarthritis patients that MRI has brought, it is very important that rheumatologists are aware of the findings that indicate actual spondyloarthritis and of the advantages of MRI,” he said.

“It is important that not only rheumatologists but also radiologists are aware of the large impact of early diagnosis and treatment of patients with SpA concerning pain relief and better function,” he noted.

By ordering MRI “at an earlier and more appropriate phase in the patient's disease,” radiologists could help patients get a quick diagnosis and allow early initiation of the relevant therapy, he added.

Dr. Østergaard discussed a study in which he participated that involved 50 patients with SpA who had an MRI done once at baseline and again on follow-up at an average of 19.2 months later. Patients also underwent spinal radiography at baseline and follow-up more than 2 years later.

The goal of the study was to use imaging to evaluate the effectiveness of anti–tumor necrosis factor (TNF)–alpha agents for treatment of vertebral corner inflammatory lesions. The study aimed to evaluate whether MRI could be used to predict the growth of new syndesmophytes after anti-TNF-alpha therapy, said Dr. Østergaard of the department of rheumatology at the University of Copenhagen and Glostrup (Denmark) Hospital, who was a coauthor.

The study showed that in patients who receive anti-TNF-alpha therapy, new syndesmophytes developed more frequently from vertebral corners where follow-up MRI had shown a completely resolved corner inflammatory lesion, compared with vertebral corners with no inflammatory lesions (42.9 % vs. 2.4 %). For patients who received standard treatment, the study reported a similar pattern (20% vs. 3.3%), he added.

The study findings indicated that MRI can predict new bone formation on radiograph, and supported the theory that anti-TNF-alpha acts to inhibit new bone formation. However, because the sample size was so small, further study will be needed to validate these findings, Dr. Østergaard said.

Dr. Østergaard had no disclosures to report.

To watch an interview with Dr. Østergaard, scan this QR code with a smartphone.

By allowing earlier detection of sacroiliitis, MRI has “enabled physicians to diagnose spondyloarthritis up to 5–10 years earlier,” said Dr. Mikkel Østergaard.

Source Heidi Splete/Elsevier Global Medical News

Magnetic resonance imaging is at least as sensitive as other modalities at predicting treatment response in patients with new-onset spondyloarthritis, according to data presented by Dr. Mikkel Østergaard.

In discussing research that pointed to the usefulness of MRI in managing patients with spondyloarthritis (SpA), Dr. Østergaard reviewed the varied manifestations SpA can take on MRI, and how imaging can be a useful tool for predicting the formation of new bone.

“MRI has brought a major improvement in the evaluation and management of patients with spondyloarthritis,” he said. “It allows earlier detection of sacroiliitis than [does] any other modality, and has thereby enabled physicians to diagnose spondyloarthritis up to 5-10 years earlier than they could before.” He added that MRI provides physicians with an objective way to monitor disease activity in SpA.

Dr. Østergaard explained how to use MRI to identify disease in the sacroiliac joints, the spine, and the peripheral joints. “Given the major improvement in evaluation and management of spondyloarthritis patients that MRI has brought, it is very important that rheumatologists are aware of the findings that indicate actual spondyloarthritis and of the advantages of MRI,” he said.

“It is important that not only rheumatologists but also radiologists are aware of the large impact of early diagnosis and treatment of patients with SpA concerning pain relief and better function,” he noted.

By ordering MRI “at an earlier and more appropriate phase in the patient's disease,” radiologists could help patients get a quick diagnosis and allow early initiation of the relevant therapy, he added.

Dr. Østergaard discussed a study in which he participated that involved 50 patients with SpA who had an MRI done once at baseline and again on follow-up at an average of 19.2 months later. Patients also underwent spinal radiography at baseline and follow-up more than 2 years later.

The goal of the study was to use imaging to evaluate the effectiveness of anti–tumor necrosis factor (TNF)–alpha agents for treatment of vertebral corner inflammatory lesions. The study aimed to evaluate whether MRI could be used to predict the growth of new syndesmophytes after anti-TNF-alpha therapy, said Dr. Østergaard of the department of rheumatology at the University of Copenhagen and Glostrup (Denmark) Hospital, who was a coauthor.

The study showed that in patients who receive anti-TNF-alpha therapy, new syndesmophytes developed more frequently from vertebral corners where follow-up MRI had shown a completely resolved corner inflammatory lesion, compared with vertebral corners with no inflammatory lesions (42.9 % vs. 2.4 %). For patients who received standard treatment, the study reported a similar pattern (20% vs. 3.3%), he added.

The study findings indicated that MRI can predict new bone formation on radiograph, and supported the theory that anti-TNF-alpha acts to inhibit new bone formation. However, because the sample size was so small, further study will be needed to validate these findings, Dr. Østergaard said.

Dr. Østergaard had no disclosures to report.

To watch an interview with Dr. Østergaard, scan this QR code with a smartphone.

By allowing earlier detection of sacroiliitis, MRI has “enabled physicians to diagnose spondyloarthritis up to 5–10 years earlier,” said Dr. Mikkel Østergaard.

Source Heidi Splete/Elsevier Global Medical News

Magnetic resonance imaging is at least as sensitive as other modalities at predicting treatment response in patients with new-onset spondyloarthritis, according to data presented by Dr. Mikkel Østergaard.

In discussing research that pointed to the usefulness of MRI in managing patients with spondyloarthritis (SpA), Dr. Østergaard reviewed the varied manifestations SpA can take on MRI, and how imaging can be a useful tool for predicting the formation of new bone.

“MRI has brought a major improvement in the evaluation and management of patients with spondyloarthritis,” he said. “It allows earlier detection of sacroiliitis than [does] any other modality, and has thereby enabled physicians to diagnose spondyloarthritis up to 5-10 years earlier than they could before.” He added that MRI provides physicians with an objective way to monitor disease activity in SpA.

Dr. Østergaard explained how to use MRI to identify disease in the sacroiliac joints, the spine, and the peripheral joints. “Given the major improvement in evaluation and management of spondyloarthritis patients that MRI has brought, it is very important that rheumatologists are aware of the findings that indicate actual spondyloarthritis and of the advantages of MRI,” he said.

“It is important that not only rheumatologists but also radiologists are aware of the large impact of early diagnosis and treatment of patients with SpA concerning pain relief and better function,” he noted.

By ordering MRI “at an earlier and more appropriate phase in the patient's disease,” radiologists could help patients get a quick diagnosis and allow early initiation of the relevant therapy, he added.

Dr. Østergaard discussed a study in which he participated that involved 50 patients with SpA who had an MRI done once at baseline and again on follow-up at an average of 19.2 months later. Patients also underwent spinal radiography at baseline and follow-up more than 2 years later.

The goal of the study was to use imaging to evaluate the effectiveness of anti–tumor necrosis factor (TNF)–alpha agents for treatment of vertebral corner inflammatory lesions. The study aimed to evaluate whether MRI could be used to predict the growth of new syndesmophytes after anti-TNF-alpha therapy, said Dr. Østergaard of the department of rheumatology at the University of Copenhagen and Glostrup (Denmark) Hospital, who was a coauthor.

The study showed that in patients who receive anti-TNF-alpha therapy, new syndesmophytes developed more frequently from vertebral corners where follow-up MRI had shown a completely resolved corner inflammatory lesion, compared with vertebral corners with no inflammatory lesions (42.9 % vs. 2.4 %). For patients who received standard treatment, the study reported a similar pattern (20% vs. 3.3%), he added.

The study findings indicated that MRI can predict new bone formation on radiograph, and supported the theory that anti-TNF-alpha acts to inhibit new bone formation. However, because the sample size was so small, further study will be needed to validate these findings, Dr. Østergaard said.

Dr. Østergaard had no disclosures to report.

To watch an interview with Dr. Østergaard, scan this QR code with a smartphone.

By allowing earlier detection of sacroiliitis, MRI has “enabled physicians to diagnose spondyloarthritis up to 5–10 years earlier,” said Dr. Mikkel Østergaard.

Source Heidi Splete/Elsevier Global Medical News

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

The federal government has launched a new website that provides evidence-based information on complementary and alternative medicine treatments, according to the National Center for Complementary and Alternative Medicine, one of the National Institutes of Health.

The site (http://nccam.nih.gov/

The site was developed based on a series of focus groups and in-person surveys that the NCCAM conducted with physicians, nurses, and physician assistants. Respondents noted that they were interested in online access to evidence-based information about CAM. According to the 2007 National Health Interview Survey, 40% of adults and 12% of children use some form of CAM. The most common uses are for musculoskeletal problems such as back, neck, or joint pain.

It's essential that physicians talk to patients about CAM use, NCCAM spokesperson Katy Danielson said in an interview: “Talking not only allows fully integrated care, but it also minimizes risks of interactions among a patient's treatments. … When providers ask their patients about CAM use, they can ensure that they are fully informed and can help patients make informed … decisions.”

The site offers patient resources including fact sheets, links to reviews and clinical practice guidelines, a summary of research studies, and a program for continuing educational credit.

The federal government has launched a new website that provides evidence-based information on complementary and alternative medicine treatments, according to the National Center for Complementary and Alternative Medicine, one of the National Institutes of Health.

The site (http://nccam.nih.gov/

The site was developed based on a series of focus groups and in-person surveys that the NCCAM conducted with physicians, nurses, and physician assistants. Respondents noted that they were interested in online access to evidence-based information about CAM. According to the 2007 National Health Interview Survey, 40% of adults and 12% of children use some form of CAM. The most common uses are for musculoskeletal problems such as back, neck, or joint pain.

It's essential that physicians talk to patients about CAM use, NCCAM spokesperson Katy Danielson said in an interview: “Talking not only allows fully integrated care, but it also minimizes risks of interactions among a patient's treatments. … When providers ask their patients about CAM use, they can ensure that they are fully informed and can help patients make informed … decisions.”

The site offers patient resources including fact sheets, links to reviews and clinical practice guidelines, a summary of research studies, and a program for continuing educational credit.

The federal government has launched a new website that provides evidence-based information on complementary and alternative medicine treatments, according to the National Center for Complementary and Alternative Medicine, one of the National Institutes of Health.

The site (http://nccam.nih.gov/

The site was developed based on a series of focus groups and in-person surveys that the NCCAM conducted with physicians, nurses, and physician assistants. Respondents noted that they were interested in online access to evidence-based information about CAM. According to the 2007 National Health Interview Survey, 40% of adults and 12% of children use some form of CAM. The most common uses are for musculoskeletal problems such as back, neck, or joint pain.

It's essential that physicians talk to patients about CAM use, NCCAM spokesperson Katy Danielson said in an interview: “Talking not only allows fully integrated care, but it also minimizes risks of interactions among a patient's treatments. … When providers ask their patients about CAM use, they can ensure that they are fully informed and can help patients make informed … decisions.”

The site offers patient resources including fact sheets, links to reviews and clinical practice guidelines, a summary of research studies, and a program for continuing educational credit.