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New Lupus Nephritis Guidelines Will Address Therapy

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CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

Dr. Bevra Hahn

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m2 of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

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CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

Dr. Bevra Hahn

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m2 of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

Dr. Bevra Hahn

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m2 of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

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FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF RHEUMATOLOGY

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MTX + Prednisone Regimen Improves Outcomes for Early RA

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MTX + Prednisone Regimen Improves Outcomes for Early RA

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

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CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

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Major Finding: Of 119 patients from who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo.

Data Source: The Computer Assisted Management of Early RA–II (CAMERA-II) randomized controlled trial.

Disclosures: The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

Rheumatoid Arthritis Doubled Fracture Risk in Younger Women

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CHICAGO – Rheumatoid arthritis more than doubles the risk of fracture in women younger than age 50, according to the results of a large population-based study.

While it’s well known that the disease drives up fracture risk in older men and women, independent of glucocorticoid use, these findings suggest that "we need to make our [younger female] patients aware" that they, too, are at increased risk so they can take precautions by not smoking, and by maintaining adequate calcium, vitamin D, and activity levels, Dr. Shreyasee Amin said at the annual meeting of the American College of Rheumatology. 

Dr. Amin and colleagues at the Mayo Clinic in Rochester, Minn., analyzed data from the Rochester Epidemiologic Project, which includes inpatient and outpatient medical records for residents of Olmstead County, Minn.

The population-based cohort included 1,171 women (70%) and men (30%) diagnosed with RA during 1955-2007. Those individuals were compared with age- and sex-matched controls without RA. The researchers followed subjects until death or their last available follow-up.*

Among women with RA, 308 were younger than 50 years; among men with RA, 110 were younger than 50 years.

Causes of fractures were categorized by whether they were incidental or not and by trauma severity: severe (for example, motor vehicle accident), moderate (fall from standing height or less), spontaneous, and pathologic (malignancy). Severe or pathologic fractures were not included in the analysis.

Overall, women with RA had a 63% greater risk of fracture than women without RA. Women with RA aged 50 years or older had a 43% greater risk of fracture, and women younger than 50 years had more than twice the risk of a fracture (Hazard Ratio, 2.34).

Overall, men with RA had a 40% greater risk of a fracture, compared with those without the disease. Among men aged 50 years and older, those with RA tended to have a greater risk of fracture. In men with RA who were younger than age 50, "we didn’t see enough fractures to determine whether they were at high risk for fracture before the age of 50," said the rheumatologist.

Steroids, which are commonly used to treat the disease, can put individuals at greater risk of fracture. But RA patients also tend to have a greater risk of fracture, independent of their steroid use. "The disease itself may play a role in the loss of bone because the inflammation that drives the joint disease also affects the cells of the bone that increase bone loss," she said.

The study primarily involved a white population, so the results can’t be extrapolated to other races or ethic groups with RA.

Dr. Amin reported that she is on the scientific advisory board for Merck.

* Correction, 11/10/2011: The original version of this story misstated how patients in this study were followed. Patients were followed until death or their last available follow-up, not their first fracture.

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CHICAGO – Rheumatoid arthritis more than doubles the risk of fracture in women younger than age 50, according to the results of a large population-based study.

While it’s well known that the disease drives up fracture risk in older men and women, independent of glucocorticoid use, these findings suggest that "we need to make our [younger female] patients aware" that they, too, are at increased risk so they can take precautions by not smoking, and by maintaining adequate calcium, vitamin D, and activity levels, Dr. Shreyasee Amin said at the annual meeting of the American College of Rheumatology. 

Dr. Amin and colleagues at the Mayo Clinic in Rochester, Minn., analyzed data from the Rochester Epidemiologic Project, which includes inpatient and outpatient medical records for residents of Olmstead County, Minn.

The population-based cohort included 1,171 women (70%) and men (30%) diagnosed with RA during 1955-2007. Those individuals were compared with age- and sex-matched controls without RA. The researchers followed subjects until death or their last available follow-up.*

Among women with RA, 308 were younger than 50 years; among men with RA, 110 were younger than 50 years.

Causes of fractures were categorized by whether they were incidental or not and by trauma severity: severe (for example, motor vehicle accident), moderate (fall from standing height or less), spontaneous, and pathologic (malignancy). Severe or pathologic fractures were not included in the analysis.

Overall, women with RA had a 63% greater risk of fracture than women without RA. Women with RA aged 50 years or older had a 43% greater risk of fracture, and women younger than 50 years had more than twice the risk of a fracture (Hazard Ratio, 2.34).

Overall, men with RA had a 40% greater risk of a fracture, compared with those without the disease. Among men aged 50 years and older, those with RA tended to have a greater risk of fracture. In men with RA who were younger than age 50, "we didn’t see enough fractures to determine whether they were at high risk for fracture before the age of 50," said the rheumatologist.

Steroids, which are commonly used to treat the disease, can put individuals at greater risk of fracture. But RA patients also tend to have a greater risk of fracture, independent of their steroid use. "The disease itself may play a role in the loss of bone because the inflammation that drives the joint disease also affects the cells of the bone that increase bone loss," she said.

The study primarily involved a white population, so the results can’t be extrapolated to other races or ethic groups with RA.

Dr. Amin reported that she is on the scientific advisory board for Merck.

* Correction, 11/10/2011: The original version of this story misstated how patients in this study were followed. Patients were followed until death or their last available follow-up, not their first fracture.

CHICAGO – Rheumatoid arthritis more than doubles the risk of fracture in women younger than age 50, according to the results of a large population-based study.

While it’s well known that the disease drives up fracture risk in older men and women, independent of glucocorticoid use, these findings suggest that "we need to make our [younger female] patients aware" that they, too, are at increased risk so they can take precautions by not smoking, and by maintaining adequate calcium, vitamin D, and activity levels, Dr. Shreyasee Amin said at the annual meeting of the American College of Rheumatology. 

Dr. Amin and colleagues at the Mayo Clinic in Rochester, Minn., analyzed data from the Rochester Epidemiologic Project, which includes inpatient and outpatient medical records for residents of Olmstead County, Minn.

The population-based cohort included 1,171 women (70%) and men (30%) diagnosed with RA during 1955-2007. Those individuals were compared with age- and sex-matched controls without RA. The researchers followed subjects until death or their last available follow-up.*

Among women with RA, 308 were younger than 50 years; among men with RA, 110 were younger than 50 years.

Causes of fractures were categorized by whether they were incidental or not and by trauma severity: severe (for example, motor vehicle accident), moderate (fall from standing height or less), spontaneous, and pathologic (malignancy). Severe or pathologic fractures were not included in the analysis.

Overall, women with RA had a 63% greater risk of fracture than women without RA. Women with RA aged 50 years or older had a 43% greater risk of fracture, and women younger than 50 years had more than twice the risk of a fracture (Hazard Ratio, 2.34).

Overall, men with RA had a 40% greater risk of a fracture, compared with those without the disease. Among men aged 50 years and older, those with RA tended to have a greater risk of fracture. In men with RA who were younger than age 50, "we didn’t see enough fractures to determine whether they were at high risk for fracture before the age of 50," said the rheumatologist.

Steroids, which are commonly used to treat the disease, can put individuals at greater risk of fracture. But RA patients also tend to have a greater risk of fracture, independent of their steroid use. "The disease itself may play a role in the loss of bone because the inflammation that drives the joint disease also affects the cells of the bone that increase bone loss," she said.

The study primarily involved a white population, so the results can’t be extrapolated to other races or ethic groups with RA.

Dr. Amin reported that she is on the scientific advisory board for Merck.

* Correction, 11/10/2011: The original version of this story misstated how patients in this study were followed. Patients were followed until death or their last available follow-up, not their first fracture.

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Major Finding: Overall, women with RA had a 63% greater risk of fracture than women without RA. Women with RA aged 50 years or older had a 43% greater risk of fracture and women younger than 50 years had more than twice the risk of a fracture (Hazard Ratio, 2.34).

Data Source: A large population-based study.

Disclosures: Dr. Amin reported that she is on the scientific advisory board for Merck.

Mild Lupus Means Healthy Pregnancies for Most Women

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CHICAGO – Women with low-activity systemic lupus erythematosus can have healthy pregnancies with few complications, even those with a history of renal disease.

"The good news was that the overall pregnancy adverse outcome was 19%, so 81% of the women [with low-activity disease] had a very favorable outcome," lead author Dr. Jill Buyon said when she announced the results of the largest such study to date at the annual meeting of the American College of Rheumatology.

The findings are very good news for women with systemic lupus erythematosus (SLE) who want to become pregnant. "Previous data suggested that women with lupus would have difficulty with regard to their own health and the health of their fetus and subsequent baby, [so] many rheumatologists have discouraged these women from childbearing," said Dr. Buyon, a professor of medicine and associate director of the division of rheumatology at New York University.

The findings suggest that rheumatologists should advise patients with very active disease to hold off on pregnancy until the disease is under better control, she said.

This study is part of a larger project, the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. "We also felt that this would be a huge opportunity to evaluate patients, whom we [rheumatologists] would normally advise to get pregnant," she said.

This study comprises four groups: women who only have antiphospholipid antibodies (group 1); women with lupus and antiphospholipid antibodies (group 2); women with lupus but no antiphospholipid antibodies (group 3); and a very selective group of healthy women, who already had a previously healthy child and no major pregnancy losses (group 4).

A total of 10 sites participated in the study, which included both rheumatologists and obstetricians. The study was initiated in 2003. At the time that the abstract was written, 700 women had been recruited to this study; at the time of abstract submission, 599 pregnancies had been completed.

Patients were all enrolled prior to 12 weeks’ gestation and were seen by a rheumatologist every trimester. Women were excluded from the study if they had a multifetal pregnancy; were on more than 20 mg/day of prednisone; had a proteinuria level greater than 1 g/day; and/or had a creatinine level greater than 1.2 mg/dL.

An adverse pregnancy outcome was strictly defined as at least one of the following: fetal/neonatal death; birth indicated at less than 36 weeks due to placental insufficiency, hypertension, or preeclampsia; and small for gestational age (less than fifth percentile).

In addition, mild/moderate and severe flares were defined by the SLEPDAI (SLE Pregnancy Disease Activity Index) score, which excludes physiologic changes of pregnancy but incorporates the components of the SELENA (Safety of Estrogen in Lupus Erythematosus National Assessment), as well as changes in clinical parameters and medications, and physician’s global assessment.

The researchers evaluated 333 women from their first trimester until 3 months post partum. Nearly half of the women were ethnicities other than white, an important characteristic given that women from minority groups can have an increased risk of SLE.

Also importantly, 31% had a history of previous lupus affecting their kidneys. "This is really important because when we see a young woman who develops lupus nephritis – and that’s a fairly serious manifestation of the disease – they always ask, ‘Even if I get better from this, does that mean that I can never have a child?’ " said Dr. Buyon.

Half of the women with a prior history of lupus nephritis had anti-DNA antibodies, "which many of us worry quite a bit about and suggests perhaps a more serious disease." However, their baseline characteristics were good in terms of low disease activity and disease stability.

When enrolled in the study, 60% of the women were taking hydroxychloroquine, 41% were taking prednisone, and 18% were taking azathioprine. On average, the participants’ lupus was relatively inactive

Fetal death occurred in 4.5%. "But if you look at the national population, this is about 2%," Dr. Buyon said.

Neonatal death in this cohort was very similar to that for neonatal death nationally: 1.2%, compared with 1% nationally.

Indicated preterm delivery or small for gestational age occurred in 9.1% of SLE pregnancies. In addition, 10% of the mothers developed preeclampsia; the national level is closer to 4%.

Greater levels of lupus activity and greater levels of antiphospholipid antibodies – particularly the lupus anticoagulant – were associated with poorer outcomes.

The researchers also performed a multivariate analysis to identify independent predictors of these poor outcomes. They found that a history of renal disease predicted a poor pregnancy outcome.

 

 

The researchers then looked at maternal outcomes. "I think this is where the news is extraordinary. ... Our mild-moderate flair rate was 18%, which we were obviously very excited about," Dr. Buyon said. Only 15 patients had a severe flare-up, and most flares did not require medication.

The study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Buyon reported that she has no relevant financial disclosures.

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CHICAGO – Women with low-activity systemic lupus erythematosus can have healthy pregnancies with few complications, even those with a history of renal disease.

"The good news was that the overall pregnancy adverse outcome was 19%, so 81% of the women [with low-activity disease] had a very favorable outcome," lead author Dr. Jill Buyon said when she announced the results of the largest such study to date at the annual meeting of the American College of Rheumatology.

The findings are very good news for women with systemic lupus erythematosus (SLE) who want to become pregnant. "Previous data suggested that women with lupus would have difficulty with regard to their own health and the health of their fetus and subsequent baby, [so] many rheumatologists have discouraged these women from childbearing," said Dr. Buyon, a professor of medicine and associate director of the division of rheumatology at New York University.

The findings suggest that rheumatologists should advise patients with very active disease to hold off on pregnancy until the disease is under better control, she said.

This study is part of a larger project, the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. "We also felt that this would be a huge opportunity to evaluate patients, whom we [rheumatologists] would normally advise to get pregnant," she said.

This study comprises four groups: women who only have antiphospholipid antibodies (group 1); women with lupus and antiphospholipid antibodies (group 2); women with lupus but no antiphospholipid antibodies (group 3); and a very selective group of healthy women, who already had a previously healthy child and no major pregnancy losses (group 4).

A total of 10 sites participated in the study, which included both rheumatologists and obstetricians. The study was initiated in 2003. At the time that the abstract was written, 700 women had been recruited to this study; at the time of abstract submission, 599 pregnancies had been completed.

Patients were all enrolled prior to 12 weeks’ gestation and were seen by a rheumatologist every trimester. Women were excluded from the study if they had a multifetal pregnancy; were on more than 20 mg/day of prednisone; had a proteinuria level greater than 1 g/day; and/or had a creatinine level greater than 1.2 mg/dL.

An adverse pregnancy outcome was strictly defined as at least one of the following: fetal/neonatal death; birth indicated at less than 36 weeks due to placental insufficiency, hypertension, or preeclampsia; and small for gestational age (less than fifth percentile).

In addition, mild/moderate and severe flares were defined by the SLEPDAI (SLE Pregnancy Disease Activity Index) score, which excludes physiologic changes of pregnancy but incorporates the components of the SELENA (Safety of Estrogen in Lupus Erythematosus National Assessment), as well as changes in clinical parameters and medications, and physician’s global assessment.

The researchers evaluated 333 women from their first trimester until 3 months post partum. Nearly half of the women were ethnicities other than white, an important characteristic given that women from minority groups can have an increased risk of SLE.

Also importantly, 31% had a history of previous lupus affecting their kidneys. "This is really important because when we see a young woman who develops lupus nephritis – and that’s a fairly serious manifestation of the disease – they always ask, ‘Even if I get better from this, does that mean that I can never have a child?’ " said Dr. Buyon.

Half of the women with a prior history of lupus nephritis had anti-DNA antibodies, "which many of us worry quite a bit about and suggests perhaps a more serious disease." However, their baseline characteristics were good in terms of low disease activity and disease stability.

When enrolled in the study, 60% of the women were taking hydroxychloroquine, 41% were taking prednisone, and 18% were taking azathioprine. On average, the participants’ lupus was relatively inactive

Fetal death occurred in 4.5%. "But if you look at the national population, this is about 2%," Dr. Buyon said.

Neonatal death in this cohort was very similar to that for neonatal death nationally: 1.2%, compared with 1% nationally.

Indicated preterm delivery or small for gestational age occurred in 9.1% of SLE pregnancies. In addition, 10% of the mothers developed preeclampsia; the national level is closer to 4%.

Greater levels of lupus activity and greater levels of antiphospholipid antibodies – particularly the lupus anticoagulant – were associated with poorer outcomes.

The researchers also performed a multivariate analysis to identify independent predictors of these poor outcomes. They found that a history of renal disease predicted a poor pregnancy outcome.

 

 

The researchers then looked at maternal outcomes. "I think this is where the news is extraordinary. ... Our mild-moderate flair rate was 18%, which we were obviously very excited about," Dr. Buyon said. Only 15 patients had a severe flare-up, and most flares did not require medication.

The study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Buyon reported that she has no relevant financial disclosures.

CHICAGO – Women with low-activity systemic lupus erythematosus can have healthy pregnancies with few complications, even those with a history of renal disease.

"The good news was that the overall pregnancy adverse outcome was 19%, so 81% of the women [with low-activity disease] had a very favorable outcome," lead author Dr. Jill Buyon said when she announced the results of the largest such study to date at the annual meeting of the American College of Rheumatology.

The findings are very good news for women with systemic lupus erythematosus (SLE) who want to become pregnant. "Previous data suggested that women with lupus would have difficulty with regard to their own health and the health of their fetus and subsequent baby, [so] many rheumatologists have discouraged these women from childbearing," said Dr. Buyon, a professor of medicine and associate director of the division of rheumatology at New York University.

The findings suggest that rheumatologists should advise patients with very active disease to hold off on pregnancy until the disease is under better control, she said.

This study is part of a larger project, the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. "We also felt that this would be a huge opportunity to evaluate patients, whom we [rheumatologists] would normally advise to get pregnant," she said.

This study comprises four groups: women who only have antiphospholipid antibodies (group 1); women with lupus and antiphospholipid antibodies (group 2); women with lupus but no antiphospholipid antibodies (group 3); and a very selective group of healthy women, who already had a previously healthy child and no major pregnancy losses (group 4).

A total of 10 sites participated in the study, which included both rheumatologists and obstetricians. The study was initiated in 2003. At the time that the abstract was written, 700 women had been recruited to this study; at the time of abstract submission, 599 pregnancies had been completed.

Patients were all enrolled prior to 12 weeks’ gestation and were seen by a rheumatologist every trimester. Women were excluded from the study if they had a multifetal pregnancy; were on more than 20 mg/day of prednisone; had a proteinuria level greater than 1 g/day; and/or had a creatinine level greater than 1.2 mg/dL.

An adverse pregnancy outcome was strictly defined as at least one of the following: fetal/neonatal death; birth indicated at less than 36 weeks due to placental insufficiency, hypertension, or preeclampsia; and small for gestational age (less than fifth percentile).

In addition, mild/moderate and severe flares were defined by the SLEPDAI (SLE Pregnancy Disease Activity Index) score, which excludes physiologic changes of pregnancy but incorporates the components of the SELENA (Safety of Estrogen in Lupus Erythematosus National Assessment), as well as changes in clinical parameters and medications, and physician’s global assessment.

The researchers evaluated 333 women from their first trimester until 3 months post partum. Nearly half of the women were ethnicities other than white, an important characteristic given that women from minority groups can have an increased risk of SLE.

Also importantly, 31% had a history of previous lupus affecting their kidneys. "This is really important because when we see a young woman who develops lupus nephritis – and that’s a fairly serious manifestation of the disease – they always ask, ‘Even if I get better from this, does that mean that I can never have a child?’ " said Dr. Buyon.

Half of the women with a prior history of lupus nephritis had anti-DNA antibodies, "which many of us worry quite a bit about and suggests perhaps a more serious disease." However, their baseline characteristics were good in terms of low disease activity and disease stability.

When enrolled in the study, 60% of the women were taking hydroxychloroquine, 41% were taking prednisone, and 18% were taking azathioprine. On average, the participants’ lupus was relatively inactive

Fetal death occurred in 4.5%. "But if you look at the national population, this is about 2%," Dr. Buyon said.

Neonatal death in this cohort was very similar to that for neonatal death nationally: 1.2%, compared with 1% nationally.

Indicated preterm delivery or small for gestational age occurred in 9.1% of SLE pregnancies. In addition, 10% of the mothers developed preeclampsia; the national level is closer to 4%.

Greater levels of lupus activity and greater levels of antiphospholipid antibodies – particularly the lupus anticoagulant – were associated with poorer outcomes.

The researchers also performed a multivariate analysis to identify independent predictors of these poor outcomes. They found that a history of renal disease predicted a poor pregnancy outcome.

 

 

The researchers then looked at maternal outcomes. "I think this is where the news is extraordinary. ... Our mild-moderate flair rate was 18%, which we were obviously very excited about," Dr. Buyon said. Only 15 patients had a severe flare-up, and most flares did not require medication.

The study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Buyon reported that she has no relevant financial disclosures.

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Major Finding: In all, 81% of the women with low-activity disease had a favorable outcome. Indicated preterm delivery or small for gestational age occurred in 9.1% of SLE pregnancies. In addition, 10% of the mothers developed preeclampsia; the national level is closer to 4%.

Data Source: A study of 333 pregnancies in women with low-activity systemic lupus erythematosus as part of the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study.

Disclosures: The study was funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Buyon reported that she has no relevant financial disclosures.

Cancer Risk From Biologics in RA Shown Negligible

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CHICAGO – Patients with rheumatoid arthritis on antitumor necrosis factor drugs have no greater risk of developing solid cancers than RA patients on disease-modifying antirheumatic drugs, according to an analysis of registry data on more than 15,000 patients tracked for up to 5 years.

Among the 15,262 patients in the RA registry, 91 of the 3,543 participants taking DMARDs (2.6%) and 295 among 11,719 participants taking anti-TNF drugs (2.5%) developed solid cancers.

"I think these results are very reassuring and follow on nicely from results of early clinical trials. Overall, the risk of solid cancer with anti-TNF therapy does not appear to be increased," lead author Dr. Kimme Hyrich said at the annual meeting of the American College of Rheumatology.

"Of course this represents therapy only up to 5 years, and we know that cancer in general can take many, many years to develop or become clinically apparent. Therefore we need to continue to follow these patients," Dr. Hyrich noted.

The study corroborates previous studies showing a minimal cancer risk associated with the use of anti-TNF agents, many of which have been used in the treatment of RA for more than 10 years. "When they were first available for widespread use, I think there was a continuing anxiety about whether or not an agent, which blocks occult tumor necrosis factor, would actually increase the risk of cancer in patients with rheumatoid arthritis," said Dr. Hyrich, who is senior lecturer and consultant in rheumatology at the University of Manchester (England).

Studies since have been limited primarily to meta-analyses of randomized controlled trials of anti-TNF drugs. These trials tend to be of limited duration, and the participating patients tend to be highly screened. The participants may not represent patients in typical practice, Dr. Hyrich said.

In 2001, the British Society for Rheumatology Biologics Register was established to track the progress of patients with severe rheumatoid arthritis and other rheumatic diseases who are taking anti-TNF therapy. The registry also tracks patients with moderate to severe RA who are being treated with nonbiologic DMARDs; these patients served as a control group in this analysis.

Cancer cases were also identified by reviewing patient records. The study data were linked with the U.K. National Health Service Information Center’s national cancer register. "This is a mandatory reporting cancer register where every confirmed cancer in the United Kingdom is recorded," she explained.

The analysis was limited to solid cancers, specifically excluding lymphoma, leukemia, and skin cancers. The researchers compared the risk out to 5 years’ follow-up for those receiving anti-TNF therapies with the risk for those receiving nonbiologic DMARD therapies.

Dr. Hyrich noted that there were differences between the two patient groups. In particular, more men were on DMARDs, and those on DMARDs were slightly older. "Both of these are recognized risk factors for cancer in general," he said. The results, however, were statistically adjusted to balance the risk between the two groups. The investigators found no significant differences between the groups after adjustment.

Dr. Hyrich reported having no relevant financial disclosures.

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CHICAGO – Patients with rheumatoid arthritis on antitumor necrosis factor drugs have no greater risk of developing solid cancers than RA patients on disease-modifying antirheumatic drugs, according to an analysis of registry data on more than 15,000 patients tracked for up to 5 years.

Among the 15,262 patients in the RA registry, 91 of the 3,543 participants taking DMARDs (2.6%) and 295 among 11,719 participants taking anti-TNF drugs (2.5%) developed solid cancers.

"I think these results are very reassuring and follow on nicely from results of early clinical trials. Overall, the risk of solid cancer with anti-TNF therapy does not appear to be increased," lead author Dr. Kimme Hyrich said at the annual meeting of the American College of Rheumatology.

"Of course this represents therapy only up to 5 years, and we know that cancer in general can take many, many years to develop or become clinically apparent. Therefore we need to continue to follow these patients," Dr. Hyrich noted.

The study corroborates previous studies showing a minimal cancer risk associated with the use of anti-TNF agents, many of which have been used in the treatment of RA for more than 10 years. "When they were first available for widespread use, I think there was a continuing anxiety about whether or not an agent, which blocks occult tumor necrosis factor, would actually increase the risk of cancer in patients with rheumatoid arthritis," said Dr. Hyrich, who is senior lecturer and consultant in rheumatology at the University of Manchester (England).

Studies since have been limited primarily to meta-analyses of randomized controlled trials of anti-TNF drugs. These trials tend to be of limited duration, and the participating patients tend to be highly screened. The participants may not represent patients in typical practice, Dr. Hyrich said.

In 2001, the British Society for Rheumatology Biologics Register was established to track the progress of patients with severe rheumatoid arthritis and other rheumatic diseases who are taking anti-TNF therapy. The registry also tracks patients with moderate to severe RA who are being treated with nonbiologic DMARDs; these patients served as a control group in this analysis.

Cancer cases were also identified by reviewing patient records. The study data were linked with the U.K. National Health Service Information Center’s national cancer register. "This is a mandatory reporting cancer register where every confirmed cancer in the United Kingdom is recorded," she explained.

The analysis was limited to solid cancers, specifically excluding lymphoma, leukemia, and skin cancers. The researchers compared the risk out to 5 years’ follow-up for those receiving anti-TNF therapies with the risk for those receiving nonbiologic DMARD therapies.

Dr. Hyrich noted that there were differences between the two patient groups. In particular, more men were on DMARDs, and those on DMARDs were slightly older. "Both of these are recognized risk factors for cancer in general," he said. The results, however, were statistically adjusted to balance the risk between the two groups. The investigators found no significant differences between the groups after adjustment.

Dr. Hyrich reported having no relevant financial disclosures.

CHICAGO – Patients with rheumatoid arthritis on antitumor necrosis factor drugs have no greater risk of developing solid cancers than RA patients on disease-modifying antirheumatic drugs, according to an analysis of registry data on more than 15,000 patients tracked for up to 5 years.

Among the 15,262 patients in the RA registry, 91 of the 3,543 participants taking DMARDs (2.6%) and 295 among 11,719 participants taking anti-TNF drugs (2.5%) developed solid cancers.

"I think these results are very reassuring and follow on nicely from results of early clinical trials. Overall, the risk of solid cancer with anti-TNF therapy does not appear to be increased," lead author Dr. Kimme Hyrich said at the annual meeting of the American College of Rheumatology.

"Of course this represents therapy only up to 5 years, and we know that cancer in general can take many, many years to develop or become clinically apparent. Therefore we need to continue to follow these patients," Dr. Hyrich noted.

The study corroborates previous studies showing a minimal cancer risk associated with the use of anti-TNF agents, many of which have been used in the treatment of RA for more than 10 years. "When they were first available for widespread use, I think there was a continuing anxiety about whether or not an agent, which blocks occult tumor necrosis factor, would actually increase the risk of cancer in patients with rheumatoid arthritis," said Dr. Hyrich, who is senior lecturer and consultant in rheumatology at the University of Manchester (England).

Studies since have been limited primarily to meta-analyses of randomized controlled trials of anti-TNF drugs. These trials tend to be of limited duration, and the participating patients tend to be highly screened. The participants may not represent patients in typical practice, Dr. Hyrich said.

In 2001, the British Society for Rheumatology Biologics Register was established to track the progress of patients with severe rheumatoid arthritis and other rheumatic diseases who are taking anti-TNF therapy. The registry also tracks patients with moderate to severe RA who are being treated with nonbiologic DMARDs; these patients served as a control group in this analysis.

Cancer cases were also identified by reviewing patient records. The study data were linked with the U.K. National Health Service Information Center’s national cancer register. "This is a mandatory reporting cancer register where every confirmed cancer in the United Kingdom is recorded," she explained.

The analysis was limited to solid cancers, specifically excluding lymphoma, leukemia, and skin cancers. The researchers compared the risk out to 5 years’ follow-up for those receiving anti-TNF therapies with the risk for those receiving nonbiologic DMARD therapies.

Dr. Hyrich noted that there were differences between the two patient groups. In particular, more men were on DMARDs, and those on DMARDs were slightly older. "Both of these are recognized risk factors for cancer in general," he said. The results, however, were statistically adjusted to balance the risk between the two groups. The investigators found no significant differences between the groups after adjustment.

Dr. Hyrich reported having no relevant financial disclosures.

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Major Finding: During 5 years of follow-up, 91 of the 3,543 participants taking DMARDs (2.6%) and 295 among 11,719 participants taking anti-TNF drugs (2.5%)developed solid cancers.

Data Source: An analysis of data from the British Society for Rheumatology Biologics Register.

Disclosures: Dr. Hyrich reported having no relevant financial disclosures.

Osteoarthritis May Drive Up Risk of Falling, Fracture

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CHICAGO – Despite their bigger bones, postmenopausal women with osteoarthritis appear to be at a greater risk of falls and subsequent fractures, compared to their counterparts without the joint disease, according to an analysis of data from a longitudinal study of more than 50,000 women.

Among the 51,386 women in GLOW (Global Longitudinal Study of Osteoporosis in Women), 40% had osteoarthritis (OA). Women with OA experienced almost 30% more falls and had a 20% greater risk of fracture than those without OA, lead author Dr. Daniel Prieto-Alhambra said at the annual meeting of the American College of Rheumatology.

"We know that patients with osteoarthritis have bigger bones, and some have actually suggested that these bones are more resistant." However, recent papers have suggested that patients with osteoarthritis experience more falls than the general population, said Dr. Prieto-Alhambra, who is a postdoctoral research fellow at the Hospital del Mar and Municipal Institute of Medical Research in Barcelona.

Coauthor Dr. Nigel Arden noted that "we’ve seen this in other cohorts before. What was new here was that the falls would actually explain the increased risk of fracture, whereas in other cohorts, it hasn’t explained it."

Part of the disconnect between bigger bones and fractures in OA is that bone mineral density (BMD) measurements do not provide an accurate picture of BMD. "The bone density measurement is a two-dimensional measurement of a three-dimensional bone," said Dr. Arden in an interview. Individuals with OA have up to an 8% greater BMD when viewed two dimensionally. However, "when you look at volumetric density, as we’ve done in another cohort, their density is the same [as those without OA] – they just have bigger bones."

All of this can lead to a potential overestimate of BMD. "In osteoporosis, we use bone density as a predictor of fracture. People with osteoarthritis have an increased bone density and therefore should have a low risk of fracture but they have an increased risk of fracture. Therefore, we were concerned that people were being falsely reassured by their increased bone density measurements," Dr. Arden added.

In addition, "when they get osteoarthritis, they have increased rates of bone loss, which again is an independent risk factor for fracture," said Dr. Arden, who is a professor of rheumatology at the University of Oxford (England).

The study included 60,393 women aged 55 years or older. For 3 years, participants from several countries, including the United States, Canada, Australia, United Kingdom, Spain, and others, were surveyed annually. Women who were at least 55 years old and who visited a practice within the previous 2 years were eligible. The women were mailed a self-administered questionnaire at baseline; follow-up questionnaires were sent at 12-month intervals for 3 years. Participants were asked if a doctor or other health care provider had told them that they had osteoarthritis or degenerative joint disease. Information on incident falls and fractures and potential confounders were self-reported. For this analysis, women with missing baseline OA or fracture information, as well as those with celiac disease or rheumatoid arthritis, were excluded.

The unadjusted hazard ratio for fracture among OA patients was 1.40 and this remained significant after multivariable adjustment (HR, 1.21). Falls were also more likely in women with OA (adjusted HR, 1.27). The association between OA and fracture remained significant even after adjusting for baseline falls (HR, 1.16).

"If falls explain the increased risk of fracture, we need to work out why these people are falling and have public health interventions to reduce those risks of falls – through physiotherapy, nutrition, and help around the home," said Dr. Arden. "We also need to worry that when we do an osteoporosis estimation that we [consider] osteoarthritis as an extra risk factor."

"We need to pay more attention to pain relief, exercise, and support around the home ... and when we assess their osteoporosis risk we need to think that their bone density may be falsely reassuring," Dr. Arden said.

Dr. Prieto-Alhambra and Dr. Arden reported that they have no relevant disclosures.

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CHICAGO – Despite their bigger bones, postmenopausal women with osteoarthritis appear to be at a greater risk of falls and subsequent fractures, compared to their counterparts without the joint disease, according to an analysis of data from a longitudinal study of more than 50,000 women.

Among the 51,386 women in GLOW (Global Longitudinal Study of Osteoporosis in Women), 40% had osteoarthritis (OA). Women with OA experienced almost 30% more falls and had a 20% greater risk of fracture than those without OA, lead author Dr. Daniel Prieto-Alhambra said at the annual meeting of the American College of Rheumatology.

"We know that patients with osteoarthritis have bigger bones, and some have actually suggested that these bones are more resistant." However, recent papers have suggested that patients with osteoarthritis experience more falls than the general population, said Dr. Prieto-Alhambra, who is a postdoctoral research fellow at the Hospital del Mar and Municipal Institute of Medical Research in Barcelona.

Coauthor Dr. Nigel Arden noted that "we’ve seen this in other cohorts before. What was new here was that the falls would actually explain the increased risk of fracture, whereas in other cohorts, it hasn’t explained it."

Part of the disconnect between bigger bones and fractures in OA is that bone mineral density (BMD) measurements do not provide an accurate picture of BMD. "The bone density measurement is a two-dimensional measurement of a three-dimensional bone," said Dr. Arden in an interview. Individuals with OA have up to an 8% greater BMD when viewed two dimensionally. However, "when you look at volumetric density, as we’ve done in another cohort, their density is the same [as those without OA] – they just have bigger bones."

All of this can lead to a potential overestimate of BMD. "In osteoporosis, we use bone density as a predictor of fracture. People with osteoarthritis have an increased bone density and therefore should have a low risk of fracture but they have an increased risk of fracture. Therefore, we were concerned that people were being falsely reassured by their increased bone density measurements," Dr. Arden added.

In addition, "when they get osteoarthritis, they have increased rates of bone loss, which again is an independent risk factor for fracture," said Dr. Arden, who is a professor of rheumatology at the University of Oxford (England).

The study included 60,393 women aged 55 years or older. For 3 years, participants from several countries, including the United States, Canada, Australia, United Kingdom, Spain, and others, were surveyed annually. Women who were at least 55 years old and who visited a practice within the previous 2 years were eligible. The women were mailed a self-administered questionnaire at baseline; follow-up questionnaires were sent at 12-month intervals for 3 years. Participants were asked if a doctor or other health care provider had told them that they had osteoarthritis or degenerative joint disease. Information on incident falls and fractures and potential confounders were self-reported. For this analysis, women with missing baseline OA or fracture information, as well as those with celiac disease or rheumatoid arthritis, were excluded.

The unadjusted hazard ratio for fracture among OA patients was 1.40 and this remained significant after multivariable adjustment (HR, 1.21). Falls were also more likely in women with OA (adjusted HR, 1.27). The association between OA and fracture remained significant even after adjusting for baseline falls (HR, 1.16).

"If falls explain the increased risk of fracture, we need to work out why these people are falling and have public health interventions to reduce those risks of falls – through physiotherapy, nutrition, and help around the home," said Dr. Arden. "We also need to worry that when we do an osteoporosis estimation that we [consider] osteoarthritis as an extra risk factor."

"We need to pay more attention to pain relief, exercise, and support around the home ... and when we assess their osteoporosis risk we need to think that their bone density may be falsely reassuring," Dr. Arden said.

Dr. Prieto-Alhambra and Dr. Arden reported that they have no relevant disclosures.

CHICAGO – Despite their bigger bones, postmenopausal women with osteoarthritis appear to be at a greater risk of falls and subsequent fractures, compared to their counterparts without the joint disease, according to an analysis of data from a longitudinal study of more than 50,000 women.

Among the 51,386 women in GLOW (Global Longitudinal Study of Osteoporosis in Women), 40% had osteoarthritis (OA). Women with OA experienced almost 30% more falls and had a 20% greater risk of fracture than those without OA, lead author Dr. Daniel Prieto-Alhambra said at the annual meeting of the American College of Rheumatology.

"We know that patients with osteoarthritis have bigger bones, and some have actually suggested that these bones are more resistant." However, recent papers have suggested that patients with osteoarthritis experience more falls than the general population, said Dr. Prieto-Alhambra, who is a postdoctoral research fellow at the Hospital del Mar and Municipal Institute of Medical Research in Barcelona.

Coauthor Dr. Nigel Arden noted that "we’ve seen this in other cohorts before. What was new here was that the falls would actually explain the increased risk of fracture, whereas in other cohorts, it hasn’t explained it."

Part of the disconnect between bigger bones and fractures in OA is that bone mineral density (BMD) measurements do not provide an accurate picture of BMD. "The bone density measurement is a two-dimensional measurement of a three-dimensional bone," said Dr. Arden in an interview. Individuals with OA have up to an 8% greater BMD when viewed two dimensionally. However, "when you look at volumetric density, as we’ve done in another cohort, their density is the same [as those without OA] – they just have bigger bones."

All of this can lead to a potential overestimate of BMD. "In osteoporosis, we use bone density as a predictor of fracture. People with osteoarthritis have an increased bone density and therefore should have a low risk of fracture but they have an increased risk of fracture. Therefore, we were concerned that people were being falsely reassured by their increased bone density measurements," Dr. Arden added.

In addition, "when they get osteoarthritis, they have increased rates of bone loss, which again is an independent risk factor for fracture," said Dr. Arden, who is a professor of rheumatology at the University of Oxford (England).

The study included 60,393 women aged 55 years or older. For 3 years, participants from several countries, including the United States, Canada, Australia, United Kingdom, Spain, and others, were surveyed annually. Women who were at least 55 years old and who visited a practice within the previous 2 years were eligible. The women were mailed a self-administered questionnaire at baseline; follow-up questionnaires were sent at 12-month intervals for 3 years. Participants were asked if a doctor or other health care provider had told them that they had osteoarthritis or degenerative joint disease. Information on incident falls and fractures and potential confounders were self-reported. For this analysis, women with missing baseline OA or fracture information, as well as those with celiac disease or rheumatoid arthritis, were excluded.

The unadjusted hazard ratio for fracture among OA patients was 1.40 and this remained significant after multivariable adjustment (HR, 1.21). Falls were also more likely in women with OA (adjusted HR, 1.27). The association between OA and fracture remained significant even after adjusting for baseline falls (HR, 1.16).

"If falls explain the increased risk of fracture, we need to work out why these people are falling and have public health interventions to reduce those risks of falls – through physiotherapy, nutrition, and help around the home," said Dr. Arden. "We also need to worry that when we do an osteoporosis estimation that we [consider] osteoarthritis as an extra risk factor."

"We need to pay more attention to pain relief, exercise, and support around the home ... and when we assess their osteoporosis risk we need to think that their bone density may be falsely reassuring," Dr. Arden said.

Dr. Prieto-Alhambra and Dr. Arden reported that they have no relevant disclosures.

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Osteoarthritis May Drive Up Risk of Falling, Fracture
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osteoarthritis, bmd, bone mineral density, falls, fractures
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osteoarthritis, bmd, bone mineral density, falls, fractures
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FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF RHEUMATOLOGY

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Major Finding: Women with osteoarthritis experienced almost 30% more falls and had a 20% greater risk of fracture than those without OA.

Data Source: An analysis of 51,386 women participating in GLOW (Global Longitudinal Study of Osteoporosis in Women).

Disclosures: Dr. Prieto-Alhambra and Dr. Arden reported that they have no relevant disclosures.