BSR Annual Conference 2011

BRIGHTON, ENGLAND – Although patients with rheumatoid arthritis may be aware that regular exercise is good for them, many are afraid to be physically active for fear of damaging their joints.

Other results of an online survey show that a large percentage of patients with rheumatoid arthritis (RA) are unsure of what exercises they can or should perform, and they feel that health care professionals do not always have adequate knowledge to advise them.

"Exercise is now a very important component within the management of RA," Ms. Rebecca-Jane Law of the School of Sport, Health, and Exercise Sciences at Bangor (Wales) University said April 12, at the British Society for Rheumatology Annual Conference.

"The benefits of high-intensity exercise in RA include improvements in aerobic capacity, strength, physical function, and psychosocial well-being," she added. Ms. Law noted that the use of exercise is a far cry from when bed-rest and splinting was advised back in the 1960s (Ann. Rheum. Dis. 1963;22:91-9) and that the view that exercise might detrimentally affect disease activity or cause exacerbation had been refuted.

However, despite the known benefits of exercise in RA – which might also potentially include improvement of cardiovascular health and prevention of muscle wasting and osteoporosis – RA patients tend to be less active than is the general population. To determine why this might be, Ms. Law and her associates developed an online questionnaire to survey the perceptions of patients towards exercise.

The 32-item questionnaire was based on previous research involving 18 patients with RA who participated in four focus groups. The discussions focused on two main areas: the effects of exercise on the joints and what affected whether people exercised or not. (Rheumatology 2010;49:2444-51).

A total of 247 patients with RA participated in the subsequent online survey. The mean age of the study cohort was 52 years, the mean disease duration was 9 years, and 88% were female. Physical activity was categorized as being low, medium, or high, with 24.5%, 36.9%, and 38.6% of patients, respectively falling into each of these categories.

Noting that only one-quarter of respondents were classed as having low physical activity, which is perhaps encouraging, Ms. Law commented that all the respondents were members of the U.K. National Rheumatoid Arthritis Society (NRAS), so may have been more proactive in the management of their disease than perhaps others with RA were.

Results showed the validity of the questionnaire and that it could be useful in examining patient perceptions in relation to exercise and joint health.

Most respondents (72%) felt that exercise was helpful for RA, although 44% were worried about causing harm to their joints and 52% saying they did not want to exercise because their joints hurt when they did so.

Under half (42%) said they knew what exercises to do and only 19% felt that health care professionals exhibited the knowledge necessary to advise on exercise.

Multiple guidelines – issued independently by the National Institute for Health and Clinical Excellence, the British Society for Rheumatology and the British Health Professionals in Rheumatology, the American College of Sports Medicine, and the European League Against Rheumatism – recommend that aerobic strengthening and mobility exercises be incorporated into patient care.

However, as these results suggest, not all health care professionals are perhaps familiar with this guidance. Or, if they are, they are not able to demonstrate to patients that they know what exercises should be performed, when, how often, and for how long.

Examining health care professional perceptions toward exercise in RA is a future avenue of research, Ms. Law suggested, as is clarifying exercise recommendations to help patients. The ACSM FITT principle, which covers the frequency, intensity, timing and, type of exercise, might be a useful starting point.

Ms. Law declared she had no conflicts of interest.

BRIGHTON, ENGLAND – Although patients with rheumatoid arthritis may be aware that regular exercise is good for them, many are afraid to be physically active for fear of damaging their joints.

Other results of an online survey show that a large percentage of patients with rheumatoid arthritis (RA) are unsure of what exercises they can or should perform, and they feel that health care professionals do not always have adequate knowledge to advise them.

"Exercise is now a very important component within the management of RA," Ms. Rebecca-Jane Law of the School of Sport, Health, and Exercise Sciences at Bangor (Wales) University said April 12, at the British Society for Rheumatology Annual Conference.

"The benefits of high-intensity exercise in RA include improvements in aerobic capacity, strength, physical function, and psychosocial well-being," she added. Ms. Law noted that the use of exercise is a far cry from when bed-rest and splinting was advised back in the 1960s (Ann. Rheum. Dis. 1963;22:91-9) and that the view that exercise might detrimentally affect disease activity or cause exacerbation had been refuted.

However, despite the known benefits of exercise in RA – which might also potentially include improvement of cardiovascular health and prevention of muscle wasting and osteoporosis – RA patients tend to be less active than is the general population. To determine why this might be, Ms. Law and her associates developed an online questionnaire to survey the perceptions of patients towards exercise.

The 32-item questionnaire was based on previous research involving 18 patients with RA who participated in four focus groups. The discussions focused on two main areas: the effects of exercise on the joints and what affected whether people exercised or not. (Rheumatology 2010;49:2444-51).

A total of 247 patients with RA participated in the subsequent online survey. The mean age of the study cohort was 52 years, the mean disease duration was 9 years, and 88% were female. Physical activity was categorized as being low, medium, or high, with 24.5%, 36.9%, and 38.6% of patients, respectively falling into each of these categories.

Noting that only one-quarter of respondents were classed as having low physical activity, which is perhaps encouraging, Ms. Law commented that all the respondents were members of the U.K. National Rheumatoid Arthritis Society (NRAS), so may have been more proactive in the management of their disease than perhaps others with RA were.

Results showed the validity of the questionnaire and that it could be useful in examining patient perceptions in relation to exercise and joint health.

Most respondents (72%) felt that exercise was helpful for RA, although 44% were worried about causing harm to their joints and 52% saying they did not want to exercise because their joints hurt when they did so.

Under half (42%) said they knew what exercises to do and only 19% felt that health care professionals exhibited the knowledge necessary to advise on exercise.

Multiple guidelines – issued independently by the National Institute for Health and Clinical Excellence, the British Society for Rheumatology and the British Health Professionals in Rheumatology, the American College of Sports Medicine, and the European League Against Rheumatism – recommend that aerobic strengthening and mobility exercises be incorporated into patient care.

However, as these results suggest, not all health care professionals are perhaps familiar with this guidance. Or, if they are, they are not able to demonstrate to patients that they know what exercises should be performed, when, how often, and for how long.

Examining health care professional perceptions toward exercise in RA is a future avenue of research, Ms. Law suggested, as is clarifying exercise recommendations to help patients. The ACSM FITT principle, which covers the frequency, intensity, timing and, type of exercise, might be a useful starting point.

Ms. Law declared she had no conflicts of interest.

BRIGHTON, ENGLAND – Although patients with rheumatoid arthritis may be aware that regular exercise is good for them, many are afraid to be physically active for fear of damaging their joints.

Other results of an online survey show that a large percentage of patients with rheumatoid arthritis (RA) are unsure of what exercises they can or should perform, and they feel that health care professionals do not always have adequate knowledge to advise them.

"Exercise is now a very important component within the management of RA," Ms. Rebecca-Jane Law of the School of Sport, Health, and Exercise Sciences at Bangor (Wales) University said April 12, at the British Society for Rheumatology Annual Conference.

"The benefits of high-intensity exercise in RA include improvements in aerobic capacity, strength, physical function, and psychosocial well-being," she added. Ms. Law noted that the use of exercise is a far cry from when bed-rest and splinting was advised back in the 1960s (Ann. Rheum. Dis. 1963;22:91-9) and that the view that exercise might detrimentally affect disease activity or cause exacerbation had been refuted.

However, despite the known benefits of exercise in RA – which might also potentially include improvement of cardiovascular health and prevention of muscle wasting and osteoporosis – RA patients tend to be less active than is the general population. To determine why this might be, Ms. Law and her associates developed an online questionnaire to survey the perceptions of patients towards exercise.

The 32-item questionnaire was based on previous research involving 18 patients with RA who participated in four focus groups. The discussions focused on two main areas: the effects of exercise on the joints and what affected whether people exercised or not. (Rheumatology 2010;49:2444-51).

A total of 247 patients with RA participated in the subsequent online survey. The mean age of the study cohort was 52 years, the mean disease duration was 9 years, and 88% were female. Physical activity was categorized as being low, medium, or high, with 24.5%, 36.9%, and 38.6% of patients, respectively falling into each of these categories.

Noting that only one-quarter of respondents were classed as having low physical activity, which is perhaps encouraging, Ms. Law commented that all the respondents were members of the U.K. National Rheumatoid Arthritis Society (NRAS), so may have been more proactive in the management of their disease than perhaps others with RA were.

Results showed the validity of the questionnaire and that it could be useful in examining patient perceptions in relation to exercise and joint health.

Most respondents (72%) felt that exercise was helpful for RA, although 44% were worried about causing harm to their joints and 52% saying they did not want to exercise because their joints hurt when they did so.

Under half (42%) said they knew what exercises to do and only 19% felt that health care professionals exhibited the knowledge necessary to advise on exercise.

Multiple guidelines – issued independently by the National Institute for Health and Clinical Excellence, the British Society for Rheumatology and the British Health Professionals in Rheumatology, the American College of Sports Medicine, and the European League Against Rheumatism – recommend that aerobic strengthening and mobility exercises be incorporated into patient care.

However, as these results suggest, not all health care professionals are perhaps familiar with this guidance. Or, if they are, they are not able to demonstrate to patients that they know what exercises should be performed, when, how often, and for how long.

Examining health care professional perceptions toward exercise in RA is a future avenue of research, Ms. Law suggested, as is clarifying exercise recommendations to help patients. The ACSM FITT principle, which covers the frequency, intensity, timing and, type of exercise, might be a useful starting point.

Ms. Law declared she had no conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – The risk of cancer is almost 50% higher in people with rheumatoid arthritis who are treated with nonbiologic agents when compared to the general population, according to data just released from the British Society for Rheumatology Biologics Register.

Although the link between rheumatoid arthritis (RA) and malignancy has been previously identified – particularly with respect to a higher risk of non-Hodgkin’s lymphoma (NHL) – these new data from the British Society for Rheumatology Biologics Register (BSRBR) are from a more-contemporary population of patients who have been treated in the era of widespread use of methotrexate (MTX) and other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Dr. Eric L. Matteson, who is a professor of medicine at the division of rheumatology at the Mayo Clinic, Rochester, Minn., noted in an interview that the registry findings seem to indicate that overall cancer risk is increased in patients with RA and that this risk is similar in patients exposed to biologics and nonbiologics, with the exception that nonmelanoma skin cancer appears to be somewhat more frequent in the biologics treated patients.

"I think the conclusions arrived at are consistent with previous studies and so not surprising regarding nonbiologics, in particular, methotrexate. A study from Australia by Dr. Rachelle Buchbinder, for example, already reported in 2008 an almost identical finding of 50% increased risk of cancer in patients with RA treated with methotrexate."

There was an estimated 50% excess risk of malignancy among RA patients exposed to MTX relative to the general population (standardized incidence ratio, 1.5; 95% confidence interval, 1.2-1.9). In that study, the risk of non-Hodgkin’s lymphoma was more than five times higher in RA patients than in the general population (SIR, 5.1; 95% CI 2.2-10.0). Other cancers for which there was evidence of increased risk were lung cancer (SIR, 2.9; 95% CI 1.6-4.8) and melanoma (SIR, 3.0; 95% CI 1.2-6.2). (Arthritis Care Res. 2008;59:794-9).

Dr. Matteson qualified his remarks by noting that he did not hear the presentation and assumes methotrexate was the comparator drug.

In reporting the findings, Dr. Louise Mercer, a clinical research fellow at the Arthritis Research UK Epidemiology Unit, University of Manchester, England, where the BRSBR is coordinated, on April 13 at the British Society for Rheumatology Annual Conference (Rheumatology 2011;50:iii37-8, abstract OP18) noted that they set a baseline for analyzing the cancer risk of biologic therapy, compared with conventional RA therapy within the BSRBR patient population – the primary reason the register was set up 10 years ago.

The analysis included 3,727 RA patients treated with nonbiologic DMARDS who were enrolled in the register between 2002 and 2008. Data from the national cancer registry for England and Wales provided information about whether or not they developed cancer. SIRs were used to compare the observed vs. the expected number of cancers and were adjusted for age and gender.

Of 148 malignancies occurring in 10,447 patient-years, 128 were solid cancers – including melanoma, and lung, breast, and colorectal cancers – and 20 were hematologic – including NHL and Hodgkin’s lymphoma. The median time from enrollment in the register to cancer diagnosis was 1.3 years, with 52% of patients dying as a result of incident cancer.

The standardized incidence ratio for all cancers was 1.48. Looking at specific types of malignancy, the highest SIR was recorded for NHL, at 3.73, although the risk of lung cancer was also substantial, with a SIR of 2.71. The SIR for colorectal cancer was 0.96.

Considering these findings, "vigilance for cancer, especially lung cancer and lymphoma should be maintained," Dr. Mercer advised.

"Our experience is that all cancers were increased by about 48%, with quite a marked increase in NHL and lung cancer, said Dr. Deborah Symmons, during a separate presentation at the meeting. An interesting finding, she noted, was that any benefit of NSAID drugs used to treat RA in lowering the risk of colorectal cancer appeared to be "wearing off."

Dr. Symmons, also of the Arthritis Research UK Epidemiology Unit in Manchester and a principle investigator for the BSRBR, explained that this adds to the evidence that, "the cancer risk in our general rheumatoid population is increased for some cancers."

These data are of interest, as they will eventually be used to compare the cancer risk of biologic vs. nonbiologic DMARDs. Such analysis is unlikely to be undertaken any time soon, however, as it is planned to occur when 20,000 years of patient follow-up have been accumulated. To date, there has been no signal that an earlier analysis is warranted.

"In the [anti-TNF] clinical trials, most of which were less than a year [in duration] there was not an increase in cancer except for [nonmelanoma skin cancer]," Dr. Symmons observed. "The cancer risk in observational studies is not increased in the short term," she added, "but we still don’t know what the long-term risk might be."

Echoing her comments were the separate findings of a Wyeth-sponsored study presented as a poster at the meeting. Dr. Peter Taylor of the Kennedy Institute of Rheumatology in London and his associates looked at the risk of malignancy associated with TNF inhibitors in registries and prospective observational studies. They reported a pooled-risk estimate of 1.11 for lymphoma, 1.45 for nonmelanoma skin cancer, and 1.79 for melanoma comparing TNF-treated patients with nonexposed RA patients.

Dr. Taylor and his team said of their findings: "This systematic review and meta-analysis provide reassurance to physicians and patients that treatment of RA patients with TNF inhibitors does not increase the risk of malignancy in general, or of lymphoma in particular, but does appear to increase the risk of skin cancer, including melanoma."

The systemic review and meta-analysis was sponsored by Wyeth. Dr. Taylor has received research grants and honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and UCB. The BSRBR is funded by a grant from the British Society for Rheumatology. The BSR receives funding from Abbott Laboratories, Biovitrum/SOBI, Merck Sharp & Dohme Ltd., Pfizer, Roche, and UCB. This income finances a separate contract between the BSR and the University of Manchester that provides and run the BSRBR. All decisions concerning data analysis, interpretation and publications are made autonomously of any industrial contribution.

Dr. Mercer, Dr. Symmons, and Dr. Matteson declared that they had no personal conflicts of interest.

BRIGHTON, ENGLAND – Multiple factors predict whether patients with inflammatory polyarthritis will require treatment with a biologic agent, according to new data from the Norfolk Arthritis Register.

Indeed, younger age, ACPA (anti–citrullinated protein/peptide antibody) positivity, and inefficacy of the first nonbiologic disease-modifying antirheumatic drug, (DMARD) within the first 6 months were associated with a higher chance of requiring biologic treatment with an anti–tumor necrosis factor (TNF) drug or rituximab (Rheumatology [Oxford] 2011;50 [suppl. 3];iii37-9, abstract OP16).

However, none of these baseline predictors is included in the National Institute for Health and Clinical Excellence (NICE) guidelines for prescribing biologic therapy," said Dr. Suzanne Verstappen, who presented the findings at the annual meeting of the British Society for Rheumatology.

More than 800 patients who were enrolled in the Norfolk Arthritis Register (NOAR), a primary care–based inception cohort, were studied, reported Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester (England). Two groups of patients were identified: those who were recruited in the prebiologic era of 1990-1994 (n = 407), and those who were recruited in 2000-2004 (n = 416), after biologic agents had become widely available in the United Kingdom.

For inclusion in the analysis, all patients had to have at least two swollen joints for 4 or more consecutive weeks. They also had to have symptom duration of less than 24 months, failure to respond to at least one nonbiologic DMARD, and 1 year or more of available follow-up data.

At baseline, the mean age of patients was 53 years in the prebiologic cohort and 57 years in the postbiologic cohort, with women accounting for about 63% of the overall study population. The average symptom duration was 5.4 and 6.7 months, respectively, and the prebiologic-era group had more swollen (seven vs. three) and tender (seven vs. three) joints than did the postbiologic-era group. DAS28 (disease activity score based on a 28-joint count) assessments were also higher at baseline in the prebiologic-era group, compared with postbiologic-era patients (4.5 vs. 3.7), although their use of nonbiologic DMARDs was lower at baseline (34% vs. 65%).

At follow-up, a higher percentage of patients in the 2000-2004 cohort had started to use a biologic agent (10.8% vs. 7.9% for the 1990-1994 cohort). As would be expected, the time before starting a biologic agent for the first time was longer (almost 12 years) for those who were recruited before these agents became available; the later cohort of patients received biologic treatment 3.9 years after recruitment into NOAR.

The most common first biologic agent used in the earlier cohort of patients was infliximab (44%) with etanercept, adalimumab, and rituximab being used in 34%, 19%, and 3% of patients, which reflected the timing of their introduction into U.K. clinical practice. Patients who were recruited later were more likely to receive adalimumab (51%), followed by etanercept (27%) and infliximab (22%).

Patients in both groups had used at least three nonbiologic DMARDs before starting biologic treatment, and around half to two-thirds of patients had also used steroids.

"In both cohorts, ACPA positivity at baseline was the strongest baseline predictor" for receiving biologic therapy, Dr. Verstappen reported. Hazard ratios were 7.58 and 4.66 for the pre- and postbiologic-era groups, respectively.

Patients with two alleles of the shared epitope were also more likely to start biologic therapy early (HR, 3.42 and 3.25 for the pre- and postbiologic-era groups, respectively).

In the postbiologic-era group, younger age was also associated with earlier biologic agent use, compared with older patients (HR, 0.97). Patients in this group were also more likely to receive biologic treatment if they had failed treatment with their first nonbiologic DMARD. (Failure was defined as either stopping the nonbiologic DMARD because of inefficacy or needing a second agent within the first 6 months of treatment.)

Baseline disease activity measures were not associated with the need to receive biologic therapy, although the study did not evaluate cumulative disease activity over time.

"If we identify patients who are ACPA positive and those who have failed their first nonbiologic DMARD very early on in the disease, we could perhaps fast-track them to biologic therapy and reduce long-term disability," Dr. Verstappen concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen stated that she had no conflicts of interest.

BRIGHTON, ENGLAND – Multiple factors predict whether patients with inflammatory polyarthritis will require treatment with a biologic agent, according to new data from the Norfolk Arthritis Register.

Indeed, younger age, ACPA (anti–citrullinated protein/peptide antibody) positivity, and inefficacy of the first nonbiologic disease-modifying antirheumatic drug, (DMARD) within the first 6 months were associated with a higher chance of requiring biologic treatment with an anti–tumor necrosis factor (TNF) drug or rituximab (Rheumatology [Oxford] 2011;50 [suppl. 3];iii37-9, abstract OP16).

However, none of these baseline predictors is included in the National Institute for Health and Clinical Excellence (NICE) guidelines for prescribing biologic therapy," said Dr. Suzanne Verstappen, who presented the findings at the annual meeting of the British Society for Rheumatology.

More than 800 patients who were enrolled in the Norfolk Arthritis Register (NOAR), a primary care–based inception cohort, were studied, reported Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester (England). Two groups of patients were identified: those who were recruited in the prebiologic era of 1990-1994 (n = 407), and those who were recruited in 2000-2004 (n = 416), after biologic agents had become widely available in the United Kingdom.

For inclusion in the analysis, all patients had to have at least two swollen joints for 4 or more consecutive weeks. They also had to have symptom duration of less than 24 months, failure to respond to at least one nonbiologic DMARD, and 1 year or more of available follow-up data.

At baseline, the mean age of patients was 53 years in the prebiologic cohort and 57 years in the postbiologic cohort, with women accounting for about 63% of the overall study population. The average symptom duration was 5.4 and 6.7 months, respectively, and the prebiologic-era group had more swollen (seven vs. three) and tender (seven vs. three) joints than did the postbiologic-era group. DAS28 (disease activity score based on a 28-joint count) assessments were also higher at baseline in the prebiologic-era group, compared with postbiologic-era patients (4.5 vs. 3.7), although their use of nonbiologic DMARDs was lower at baseline (34% vs. 65%).

At follow-up, a higher percentage of patients in the 2000-2004 cohort had started to use a biologic agent (10.8% vs. 7.9% for the 1990-1994 cohort). As would be expected, the time before starting a biologic agent for the first time was longer (almost 12 years) for those who were recruited before these agents became available; the later cohort of patients received biologic treatment 3.9 years after recruitment into NOAR.

The most common first biologic agent used in the earlier cohort of patients was infliximab (44%) with etanercept, adalimumab, and rituximab being used in 34%, 19%, and 3% of patients, which reflected the timing of their introduction into U.K. clinical practice. Patients who were recruited later were more likely to receive adalimumab (51%), followed by etanercept (27%) and infliximab (22%).

Patients in both groups had used at least three nonbiologic DMARDs before starting biologic treatment, and around half to two-thirds of patients had also used steroids.

"In both cohorts, ACPA positivity at baseline was the strongest baseline predictor" for receiving biologic therapy, Dr. Verstappen reported. Hazard ratios were 7.58 and 4.66 for the pre- and postbiologic-era groups, respectively.

Patients with two alleles of the shared epitope were also more likely to start biologic therapy early (HR, 3.42 and 3.25 for the pre- and postbiologic-era groups, respectively).

In the postbiologic-era group, younger age was also associated with earlier biologic agent use, compared with older patients (HR, 0.97). Patients in this group were also more likely to receive biologic treatment if they had failed treatment with their first nonbiologic DMARD. (Failure was defined as either stopping the nonbiologic DMARD because of inefficacy or needing a second agent within the first 6 months of treatment.)

Baseline disease activity measures were not associated with the need to receive biologic therapy, although the study did not evaluate cumulative disease activity over time.

"If we identify patients who are ACPA positive and those who have failed their first nonbiologic DMARD very early on in the disease, we could perhaps fast-track them to biologic therapy and reduce long-term disability," Dr. Verstappen concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen stated that she had no conflicts of interest.

BRIGHTON, ENGLAND – Multiple factors predict whether patients with inflammatory polyarthritis will require treatment with a biologic agent, according to new data from the Norfolk Arthritis Register.

Indeed, younger age, ACPA (anti–citrullinated protein/peptide antibody) positivity, and inefficacy of the first nonbiologic disease-modifying antirheumatic drug, (DMARD) within the first 6 months were associated with a higher chance of requiring biologic treatment with an anti–tumor necrosis factor (TNF) drug or rituximab (Rheumatology [Oxford] 2011;50 [suppl. 3];iii37-9, abstract OP16).

However, none of these baseline predictors is included in the National Institute for Health and Clinical Excellence (NICE) guidelines for prescribing biologic therapy," said Dr. Suzanne Verstappen, who presented the findings at the annual meeting of the British Society for Rheumatology.

More than 800 patients who were enrolled in the Norfolk Arthritis Register (NOAR), a primary care–based inception cohort, were studied, reported Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester (England). Two groups of patients were identified: those who were recruited in the prebiologic era of 1990-1994 (n = 407), and those who were recruited in 2000-2004 (n = 416), after biologic agents had become widely available in the United Kingdom.

For inclusion in the analysis, all patients had to have at least two swollen joints for 4 or more consecutive weeks. They also had to have symptom duration of less than 24 months, failure to respond to at least one nonbiologic DMARD, and 1 year or more of available follow-up data.

At baseline, the mean age of patients was 53 years in the prebiologic cohort and 57 years in the postbiologic cohort, with women accounting for about 63% of the overall study population. The average symptom duration was 5.4 and 6.7 months, respectively, and the prebiologic-era group had more swollen (seven vs. three) and tender (seven vs. three) joints than did the postbiologic-era group. DAS28 (disease activity score based on a 28-joint count) assessments were also higher at baseline in the prebiologic-era group, compared with postbiologic-era patients (4.5 vs. 3.7), although their use of nonbiologic DMARDs was lower at baseline (34% vs. 65%).

At follow-up, a higher percentage of patients in the 2000-2004 cohort had started to use a biologic agent (10.8% vs. 7.9% for the 1990-1994 cohort). As would be expected, the time before starting a biologic agent for the first time was longer (almost 12 years) for those who were recruited before these agents became available; the later cohort of patients received biologic treatment 3.9 years after recruitment into NOAR.

The most common first biologic agent used in the earlier cohort of patients was infliximab (44%) with etanercept, adalimumab, and rituximab being used in 34%, 19%, and 3% of patients, which reflected the timing of their introduction into U.K. clinical practice. Patients who were recruited later were more likely to receive adalimumab (51%), followed by etanercept (27%) and infliximab (22%).

Patients in both groups had used at least three nonbiologic DMARDs before starting biologic treatment, and around half to two-thirds of patients had also used steroids.

"In both cohorts, ACPA positivity at baseline was the strongest baseline predictor" for receiving biologic therapy, Dr. Verstappen reported. Hazard ratios were 7.58 and 4.66 for the pre- and postbiologic-era groups, respectively.

Patients with two alleles of the shared epitope were also more likely to start biologic therapy early (HR, 3.42 and 3.25 for the pre- and postbiologic-era groups, respectively).

In the postbiologic-era group, younger age was also associated with earlier biologic agent use, compared with older patients (HR, 0.97). Patients in this group were also more likely to receive biologic treatment if they had failed treatment with their first nonbiologic DMARD. (Failure was defined as either stopping the nonbiologic DMARD because of inefficacy or needing a second agent within the first 6 months of treatment.)

Baseline disease activity measures were not associated with the need to receive biologic therapy, although the study did not evaluate cumulative disease activity over time.

"If we identify patients who are ACPA positive and those who have failed their first nonbiologic DMARD very early on in the disease, we could perhaps fast-track them to biologic therapy and reduce long-term disability," Dr. Verstappen concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen stated that she had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – The gait of patients with rheumatoid arthritis undergoes significant variation throughout the day, judging from findings from the DIVIGN study.

There was a 54% improvement in gait velocity overall from the start to the end of a 12-hour assessment period. The mean improvement ranged from -41% to +397%.

The findings suggest that gait velocity should be measured at the same time of day in each patient when used as an outcome measure in clinical practice or in research.

"We all know about morning stiffness and how frequently patients report this, but this is really the first attempt to quantify the effects of early morning stiffness on gait," Michael Backhouse, a podiatrist and Arthritis Research UK doctoral student at the University of Leeds, England, said at the annual meeting of the British Society for Rheumatology.

Mr. Backhouse explained that patients with rheumatoid arthritis (RA) are known to have marked gait abnormalities. This includes decreased gait velocity, reduced stride length, and more time spent in a walking phase called double support where both feet are on the ground before one or the other leg swings forward to take the next step.

To quantify the diurnal variation in gait velocity, the investigators enrolled 31 patients with RA with a median age of 67 years and 10.5 years’ disease duration who were being treated as inpatients at the Chapel Allerton Hospital in Leeds. All patients reported morning stiffness for at least 30 minutes or more every day.

Each patient was asked to walk along a 5.2-m instrumented walkway (GAITRite, CIR Systems Inc.) at five time points throughout the study day; soon after waking (0 hour) at 7 am then at 1-, 3-, 6- and 12-hour intervals. Patients were asked to walk at a self-selected pace and were allowed to use walking sticks or other aids if required.

A visual analog scale was used to determine morning stiffness, and the Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) 28 were used to see how changes in gait velocity might influence these disease outcome measures.

The sharpest increases in gait velocity were seen in the first hour of each patient assessment, with continued improvement throughout the day. At baseline, the mean gait velocity for all patients was 37.8 cm/sec., with values at 1, 3, 6, and 12 hours of 43.8 cm/sec., 45.5 cm/sec., 48.1 cm./sec., and 53 cm/sec. These translated into overall improvements of 20.4%, 32.9%, 37.8%, and 54.1% improvements, compared with baseline.

Although no control group of similarly aged individuals without RA was assessed, Mr. Backhouse observed that the expected gait velocity of healthy elderly individuals would be about 80-100 cm/sec.

In addition, stride length increased throughout the day, and patients were better able to steady themselves between steps (i.e., longer duration of the double support walking phase) before moving forward.

"When we looked at absolute gait velocity, that’s how fast patients were actually walking, we found that it did correlate with HAQ, that’s patient-reported physical function, at all time points, but it didn’t correlate at all with DAS28 or current disease activity," Mr. Backhouse reported.

"Gait velocity is perhaps one of the most widely used clinical outcome measure in studies of RA," Mr. Backhouse further observed. "This is probably because gait velocity can be so easily and objectively measured," he continued.

However, as the results of the DIVIGN study show, "there is marked diurnal variation of gait velocity ... and repeat measures should be made at the same time of day to exclude its effects," Mr. Backhouse concluded.

Arthritis Research UK and the National Institute for Health Research (London) funded the study. Mr. Backhouse said he had no conflicts of interest.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you've got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it's very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.

BRIGHTON, ENGLAND – Survival from scleroderma is improving, but major organ-based complications are still a significant reason for premature death, according to the results of a long-term outcomes study that were presented at the annual meeting of the British Society for Rheumatology.

The 10-year survival rates were 81% for patients with limited cutaneous systemic sclerosis (SSc) and 70% for patients with diffuse cutaneous SSc (P = .006).

Survival was significantly reduced (39%) in those who developed major heart, lung, or kidney complications, compared with 71% for those who developed no complications at 15 years' follow-up (P less than .001).

"The 10-year survival is impressive when you consider that not so long ago, we had a 5-year morality approaching 50% in the worst cases. So clearly there has been overall progress in managing the disease," commented study investigator Dr. Christopher Denton.

"Although outcomes are improving, we're still dealing with a disease that has very high case-specific mortality," added Dr. Denton, who is a professor of experimental rheumatology at University College London and a consultant rheumatologist at the Royal Free Hospital, London.

"Around 60% of patients actually die as a direct consequence of their scleroderma, and this is mostly from cardiorespiratory complications of the disease," he added.

Almost 400 patients with scleroderma – of whom 252 (63.3%) had limited cutaneous SSc and 146 (36.7%) had diffuse cutaneous SSc – were studied from their diagnosis in 1995 to 1999 (Rheumatology [Oxford] 2011;50 [suppl. 3]:iii129-iii37, abstract 223). The percentage of men with diffuse cutaneous SSc vs. limited cutaneous SSc disease was higher (17.9% vs. 9.9%; P = .037) and the mean age of onset was 50 years for limited cutaneous SSc patients and 46 years for diffuse cutaneous SSc patients (P = .003).

An important point of the study was that the frequency and timing of the major complications of scleroderma have now been defined over a 10- to 15-year period. Complications of scleroderma can be life threatening, and include pulmonary arterial hypertension (PAH), pulmonary fibrosis, renal disease, and cardiac problems.

At the 10-year follow-up, the incidences of PAH in the limited cutaneous SSc and diffuse cutaneous SSc groups were similar (15% vs. 13%), with the earliest cases seen 2 years after diagnosis. Patients who developed this complication later in the course of their disease tended to have higher 5-year survival rates than did those who had PAH earlier (49% vs. 24%), but this did not reach statistical significance.

Clinically significant pulmonary fibrosis was identified in a higher percentage of patients with diffuse than with limited disease at 10 years (45% vs. 21%; P less than .001), with almost half of patients developing lung disease within the first 3 years, and more than three-quarters within the first 5 years.

Patients with diffuse cutaneous SSc were more likely than those with limited cutaneous SSc to experience renal crisis (12% vs. 4%) at 10 years, with the higher rates occurring in the first 3 years (10% vs. 3%). Similarly, cardiac disease was more common in diffuse cutaneous SSc than in limited cutaneous SSc patients early on (7% vs. 1% at 5 years; P less than .001), but remained unchanged at 10 years.

"Whereas the limited or diffuse distinction is very relevant in the first 5 years, after the 5 years it doesn’t really matter which type of scleroderma you’ve got; you have an equally high frequency of complications," Dr. Denton observed in an interview.

He added that this "is a treated cohort that received standard management, so I think it’s very important to start to understand the timing and frequency of the major heart, lung, and kidney complications, so that you can really identify when in the course of the disease you should be particularly vigilant."

Dr. Denton disclosed financial relationships with Actelion, Aspreva, BioVitrum, Digna, Dyax, Encysive, Genzyme, GlaxoSmithKline, Medimmune, Pfizer, and Sanofi-Aventis.