EULAR (European League Against Rheumatism): 2011 Congress

LONDON – The reasons why fewer black than white patients undergo knee replacement as a treatment option for end-stage osteoarthritis remain elusive.

According to the findings of a 725-patient study, women and blacks with knee osteoarthritis (OA) were less willing than men or their white counterparts to consider having total knee replacement (TKR) surgery.

Black patients were also found to be less aware of the benefits of joint replacement and had worse expectations of the outcome than did white patients.

Despite a number of sociocultural differences, however, it is not clear why the uptake of TKR differs among ethnic groups.

"We know that joint replacement is an effective – actually the only effective – intervention for end-stage osteoarthritis," said study author Dr. C. Kent Kwoh, who is professor of medicine, epidemiology and clinical and translational science at the University of Pittsburgh and chief of the rheumatology section at VA Pittsburgh Healthcare System.

"The problem is that there have been many studies that have shown there are disparities in joint replacement; [blacks] get hip and knee replacement much less often than do whites," Dr. Kwoh added in an interview during a poster session at the annual European Congress of Rheumatology. "The question is, Why?"

Previous research has shown that even when faced with very severe and painful OA and a physician recommendation for TKR, black patients are less willing than whites to consider this an option.

The present study was in a much larger community-based sample than has been the case in past investigations, said Dr. Kwoh, and it aimed to identify more specific factors and patient attitudes that might influence the decision to undergo TKR.

Using a cross-sectional survey design, the investigators recruited patients aged 50 years or older who had chronic, frequent knee pain and radiographic evidence of OA.

The study population consisted of 234 black and 491 white patients, with mean respective ages of 58 years and 68 years (P less than .0004).

In addition to being younger, black patients tended to have worse knee pain, with higher total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores (54 vs. 43), and OA Pain Assessment scores for constant (7 vs. 11) and intermittent (14 vs. 11) pain than white patients (P less than .0004 for all comparisons).

"There were differences in a number of [other] variables [between whites and blacks], such as income, employment status, education, access to insurance, expectations of outcome, trust in the health system, and religiosity, that may impact the choice for joint replacement" Dr. Kwoh observed.

However, putting all of these variables into a multivariate model didn’t seem to fully explain the disparity in TKR acceptance between the two groups.

The adjusted odds ratio for willingness to undergo TKR was 0.38 comparing black vs. white patients (95% confidence interval, 0.19-0.74; P = .005) and 2.52 for male vs. female sex (95% CI, 1.37-4.66; P = .003).

"We’re left a little bit puzzled at this point," Dr. Kwoh admitted. "Our other studies have shown differences in expectations; that is, if you have worse expectations, you were less likely to consider joint replacement."

In that previous work, however, an adjustment of the findings according to patient expectations seemed to take care of the difference in willingness. "In this study, we weren’t able to show that," Dr. Kwoh said. "So maybe there are other, unmeasured confounders that we have to address."

As to where these findings leave the practicing physician who advises patients, Dr. Kwoh noted that patient education is important and that patients really need to have a good understanding of the risks and benefits.

"Joint replacement is effective, we know that it works very well, it has low morbidity and low mortality, and so patients who really need it should avail themselves to it," Dr. Kwoh advised.

Dr. Kwoh stated that he had no conflicts of interest. The study was funded by the University of Pittsburgh Multidisciplinary Clinical Research Center for Rheumatic and Musculoskeletal Diseases.

LONDON – The reasons why fewer black than white patients undergo knee replacement as a treatment option for end-stage osteoarthritis remain elusive.

According to the findings of a 725-patient study, women and blacks with knee osteoarthritis (OA) were less willing than men or their white counterparts to consider having total knee replacement (TKR) surgery.

Black patients were also found to be less aware of the benefits of joint replacement and had worse expectations of the outcome than did white patients.

Despite a number of sociocultural differences, however, it is not clear why the uptake of TKR differs among ethnic groups.

"We know that joint replacement is an effective – actually the only effective – intervention for end-stage osteoarthritis," said study author Dr. C. Kent Kwoh, who is professor of medicine, epidemiology and clinical and translational science at the University of Pittsburgh and chief of the rheumatology section at VA Pittsburgh Healthcare System.

"The problem is that there have been many studies that have shown there are disparities in joint replacement; [blacks] get hip and knee replacement much less often than do whites," Dr. Kwoh added in an interview during a poster session at the annual European Congress of Rheumatology. "The question is, Why?"

Previous research has shown that even when faced with very severe and painful OA and a physician recommendation for TKR, black patients are less willing than whites to consider this an option.

The present study was in a much larger community-based sample than has been the case in past investigations, said Dr. Kwoh, and it aimed to identify more specific factors and patient attitudes that might influence the decision to undergo TKR.

Using a cross-sectional survey design, the investigators recruited patients aged 50 years or older who had chronic, frequent knee pain and radiographic evidence of OA.

The study population consisted of 234 black and 491 white patients, with mean respective ages of 58 years and 68 years (P less than .0004).

In addition to being younger, black patients tended to have worse knee pain, with higher total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores (54 vs. 43), and OA Pain Assessment scores for constant (7 vs. 11) and intermittent (14 vs. 11) pain than white patients (P less than .0004 for all comparisons).

"There were differences in a number of [other] variables [between whites and blacks], such as income, employment status, education, access to insurance, expectations of outcome, trust in the health system, and religiosity, that may impact the choice for joint replacement" Dr. Kwoh observed.

However, putting all of these variables into a multivariate model didn’t seem to fully explain the disparity in TKR acceptance between the two groups.

The adjusted odds ratio for willingness to undergo TKR was 0.38 comparing black vs. white patients (95% confidence interval, 0.19-0.74; P = .005) and 2.52 for male vs. female sex (95% CI, 1.37-4.66; P = .003).

"We’re left a little bit puzzled at this point," Dr. Kwoh admitted. "Our other studies have shown differences in expectations; that is, if you have worse expectations, you were less likely to consider joint replacement."

In that previous work, however, an adjustment of the findings according to patient expectations seemed to take care of the difference in willingness. "In this study, we weren’t able to show that," Dr. Kwoh said. "So maybe there are other, unmeasured confounders that we have to address."

As to where these findings leave the practicing physician who advises patients, Dr. Kwoh noted that patient education is important and that patients really need to have a good understanding of the risks and benefits.

"Joint replacement is effective, we know that it works very well, it has low morbidity and low mortality, and so patients who really need it should avail themselves to it," Dr. Kwoh advised.

Dr. Kwoh stated that he had no conflicts of interest. The study was funded by the University of Pittsburgh Multidisciplinary Clinical Research Center for Rheumatic and Musculoskeletal Diseases.

LONDON – The reasons why fewer black than white patients undergo knee replacement as a treatment option for end-stage osteoarthritis remain elusive.

According to the findings of a 725-patient study, women and blacks with knee osteoarthritis (OA) were less willing than men or their white counterparts to consider having total knee replacement (TKR) surgery.

Black patients were also found to be less aware of the benefits of joint replacement and had worse expectations of the outcome than did white patients.

Despite a number of sociocultural differences, however, it is not clear why the uptake of TKR differs among ethnic groups.

"We know that joint replacement is an effective – actually the only effective – intervention for end-stage osteoarthritis," said study author Dr. C. Kent Kwoh, who is professor of medicine, epidemiology and clinical and translational science at the University of Pittsburgh and chief of the rheumatology section at VA Pittsburgh Healthcare System.

"The problem is that there have been many studies that have shown there are disparities in joint replacement; [blacks] get hip and knee replacement much less often than do whites," Dr. Kwoh added in an interview during a poster session at the annual European Congress of Rheumatology. "The question is, Why?"

Previous research has shown that even when faced with very severe and painful OA and a physician recommendation for TKR, black patients are less willing than whites to consider this an option.

The present study was in a much larger community-based sample than has been the case in past investigations, said Dr. Kwoh, and it aimed to identify more specific factors and patient attitudes that might influence the decision to undergo TKR.

Using a cross-sectional survey design, the investigators recruited patients aged 50 years or older who had chronic, frequent knee pain and radiographic evidence of OA.

The study population consisted of 234 black and 491 white patients, with mean respective ages of 58 years and 68 years (P less than .0004).

In addition to being younger, black patients tended to have worse knee pain, with higher total WOMAC (Western Ontario and McMaster Universities) osteoarthritis index scores (54 vs. 43), and OA Pain Assessment scores for constant (7 vs. 11) and intermittent (14 vs. 11) pain than white patients (P less than .0004 for all comparisons).

"There were differences in a number of [other] variables [between whites and blacks], such as income, employment status, education, access to insurance, expectations of outcome, trust in the health system, and religiosity, that may impact the choice for joint replacement" Dr. Kwoh observed.

However, putting all of these variables into a multivariate model didn’t seem to fully explain the disparity in TKR acceptance between the two groups.

The adjusted odds ratio for willingness to undergo TKR was 0.38 comparing black vs. white patients (95% confidence interval, 0.19-0.74; P = .005) and 2.52 for male vs. female sex (95% CI, 1.37-4.66; P = .003).

"We’re left a little bit puzzled at this point," Dr. Kwoh admitted. "Our other studies have shown differences in expectations; that is, if you have worse expectations, you were less likely to consider joint replacement."

In that previous work, however, an adjustment of the findings according to patient expectations seemed to take care of the difference in willingness. "In this study, we weren’t able to show that," Dr. Kwoh said. "So maybe there are other, unmeasured confounders that we have to address."

As to where these findings leave the practicing physician who advises patients, Dr. Kwoh noted that patient education is important and that patients really need to have a good understanding of the risks and benefits.

"Joint replacement is effective, we know that it works very well, it has low morbidity and low mortality, and so patients who really need it should avail themselves to it," Dr. Kwoh advised.

Dr. Kwoh stated that he had no conflicts of interest. The study was funded by the University of Pittsburgh Multidisciplinary Clinical Research Center for Rheumatic and Musculoskeletal Diseases.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – Statin therapy can reverse one of the most important side effects observed in clinical trials of the experimental oral biologic tofacitinib in rheumatoid arthritis, a study has shown.

Concomitant treatment with atorvastatin significantly lessened dyslipidemia observed in a cohort of rheumatoid arthritis patients taking tofacitinib in a phase II trial.

Of 111 rheumatoid arthritis patients enrolled in the study, tofacitinib-treated patients who took atorvastatin (Lipitor) following an open-label lead-in period had a 35% reduction in mean low-density lipoprotein cholesterol (LDL-C) compared with a 5.8% increase observed in tofacitinib-treated patients randomized to concomitant placebo. Those who took atorvastatin had improvements in other lipid measures as well, reported Dr. Iain McInnes of the University of Glasgow (Scotland).

Treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor being investigated as a targeted immunomodulator, has been associated with increases in serum lipids, including LDL and HDL cholesterol and triglycerides in phase II and III rheumatoid arthritis trials, said Dr. McInnes. The same effect is seen with other JAK inhibitors. Certain proinflammatory cytokines have been shown to have an effect on serum lipid levels. Considering the synergy between inflammation and lipid metabolism, "it should be no surprise at all that an agent that modifies inflammation can also cause metabolic changes," he said at the annual European Congress of Rheumatology.

To evaluate whether use of a lipid-lowering drug could safely and effectively modulate lipid increases associated with tofacitinib treatment, Dr. McInnes and his colleagues evaluated the lipid levels of study patients who completed 6 weeks of 10-mg tofacitinib twice daily and were subsequently randomized to an additional 6 weeks of treatment with concomitant atorvastatin or placebo.

From baseline to week 6 of tofacitinib therapy, the average increases for the predominantly female study group (mean age, 52 years) were 185-230 mg/dL for total cholesterol; 109-126 mg/dL for LDL-C; 51-67 mg/dL for high-density lipoprotein cholesterol (HDL-C); 136-165 mg/dL for apolipoprotein A-1; 87-97 mg/dL for apolipoprotein B; and 100-109 mg/dL for triglycerides, Dr. McInnes reported. By week 12, total cholesterol, LDL-C, apolipoprotein B, and triglycerides were significantly decreased in the atorvastatin patients relative to placebo, "to levels below those observed at baseline," he said, while the HDL-C levels increased similarly in both the placebo and atorvastatin groups from week 6 to week 12.

With respect to clinical responses, at week 6, a minimum 20% improvement in American College of Rheumatology criteria (ACR20) was seen in 76% of the study population. "By week 12, 82.6% of the atorvastatin group exhibited an ACR20 response, compared with 65.2% of the placebo group, and 67.4% of the atorvastatin group vs. 45.7% exhibited a minimum 50% improvement in ACR criteria [ACR50)," said Dr. McInnes, who noted that, although the differences in clinical response between the atorvastatin and placebo groups were not statistically significant, the trend toward additional improvements are notable and warrant further study.

In safety analyses, the investigators observed a safety profile similar to that reported in other tofacitinib trials in rheumatoid arthritis, said Dr. McInnes. Specifically, treatment-related adverse events were experienced by 23.4% of the patients during the first 6 weeks of the study, and by 10% of the atorvastatin group and 17% of the placebo group from week 6 to week 12, said Dr. McInnes. Serious adverse events, including pneumonia, occurred in 1.8% of the patients during the open-label phase of the study, he said, noting that none of the atorvastatin patients and 2.1% of the placebo patients experienced serious adverse events between weeks 6 and 12.

"The findings of this study are important in that they demonstrate that any changes in lipids are reversible by addition of a statin," Dr. McInnes said in an interview. "It’s too early to determine how statins and tofacitinib will be used in standard of care. More data are required at this stage."

Dr. Joel Kremer agreed. The chief of medicine at Albany Medical College in New York, Dr. Kremer was the lead investigator of a phase III trial that he reported at the meeting. Data from the phase III trial demonstrated the efficacy of tofacitinib in rheumatoid arthritis patients who failed to respond to treatment with other disease-modifying antirheumatic drugs.

In an interview, Dr. Kremer noted that it’s uncertain whether concurrent lipid-lowering therapy will be considered routine standard of care with tofacitinib in rheumatoid arthritis patients, "but it probably will become quite common, as it is becoming common with Actemra [tocilizumab]."

Dr. McInnes and Dr. Kremer disclosed receiving grant and research support from and serving as consultants for Pfizer.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic treatment may open a "therapeutic window" for the improved nonmedical management of rheumatoid arthritis, according to a leading Swedish physiotherapist at the annual European Congress of Rheumatology.

The advent of biologics just over a decade ago has undoubtedly tightened disease control and improved outcomes, compared with more conventional therapies for many patients with RA.

But biologics have also made it much more possible for patients to undertake prescribed exercise regimens that are recommended for older adults with chronic diseases such as arthritis, said Christina Opava of the Karolinska Institutetand Karolinska University Hospital in Stockholm.

"Biologics do not necessarily take away the need for exercise, but they may open up a therapeutic window for people to regain and maintain their physical activity while on treatment," she noted.

In an interview, Ms. Opava added that "everything is not about disease control. We also need to pay attention to a healthy lifestyle."

Over the past few decades, the treatment of RA has changed dramatically, with improved medications and nonmedical options. In addition, many more patients today are empowered to self-manage their condition, and have greater expectations of and worries about how treatments and their disease will affect their overall quality and duration of life.

In a recent review article, four nonpharmacologic options topped the list of strategies that have a sound evidence base: self-management interventions, exercise or a suitable physical activity program, comprehensive occupational therapy with patients who are able to work but are at risk of losing their jobs, and use of wrist and finger splints (Curr. Opin. Rheumatol. 2011;23:259-64).

More research is needed on the use of assistive devices, foot orthoses, and dietary interventions in order to determine the true effectiveness of the strategies, the review authors suggested.

Having worked as a rheumatology health care professional for more than 30 years, Ms. Opava emphasized that nonmedical options should not be forgotten. Strategies to help patients self-manage their condition, for example, may include tailored patient education, behavioral and cognitive approaches, and individualized weekly action plans (Ann. Rheum. Dis. 2010;69:955-63).

Ms. Opava’s research has focused on the benefits of regular exercise in arthritis, and determining what the minimum amount of exercise could be and how this could be most effectively prescribed (Arthritis Rheum. 2003;49:428-34). Planned and structured exercise has been shown to be effective in RA, and "by now, there are enough studies to support its safety as well as its benefit," she said.

The challenge, of course, is that not all patients may be able to partake in the same level or type of exercise, which – according to the American College of Sports Medicine guidelines – can be the same for adults aged 50-64 years with a chronic condition such as arthritis and those aged 65 years or older.

"Everyone has to choose their own mode of exercise," Ms. Opava explained, noting that health care professionals need to assess the patient’s physical capacity before prescribing any form of exercise or physical activity program. Exercise and physical activity also need to be enjoyable for patients, so that there is greater likelihood that patients will stick with their exercise regimen.

Patient education and empowerment are vital to achieving and maintaining a healthy lifestyle that includes appropriate exercise and physical activity. All health care professionals who treat patients with arthritis should reinforce the benefits of healthy living as a central component of managing the condition, Ms. Opava suggested.

"Most of us know what a healthy lifestyle is, but it’s more difficult to lead a healthy lifestyle consistently," she added, noting that it basically involved avoiding physical inactivity, eating a healthful diet, moderating alcohol intake, and not smoking.

Ms. Opava had no conflicts of interest to declare.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.

LONDON – Biologic therapies do not increase the overall risk of cancer in patients with inflammatory arthritis, according to observational data from the Danish Biologics Register, DANBIO, presented by Dr. Lene Dreyer at the annual European Congress of Rheumatology.

After an average of 9 years of follow-up, and representing almost 24,000 patient-years of treatment, the relative risk (RR) for developing any type of cancer for the first time was 1.03 (95% confidence interval [CI] 0.82-1.30) when comparing anti–tumor necrosis factor (anti-TNF) therapy with no biologic treatment.

The cancer risk was also not increased in patients with rheumatoid arthritis (RR = 1.05; 95% CI 0.82-1.34), psoriatic arthritis (RR = 1.98; 95% CI 0.24-16.18)), or other arthritic diseases including ankylosing spondylitis (RR = 0.79; 95% CI 0.08-8.33).

Preliminary results suggest that the risk of nonmelanoma skin cancer (RR = 1.11; 95% CI 0.70-1.76) and non-Hodgkin’s lymphoma are also not increased (RR = 0.55; 95% CI 0.16-1.90).

While the findings add to increasing evidence that biologics may not increase cancer risk overall, more analysis is needed to determine if certain types of cancer are more likely to occur in the study population, or if certain patients are at greater risk of malignancy than others. Longer follow-up is also needed to rule out cancers that may take longer than a decade to manifest.

"There has always been concern for an increased risk of lymphoma with TNF-blockers," said Dr. Georg Schett, chair of the department of internal medicine, rheumatology, and clinical immunology at Friedrich-Alexander University Erlangen in Nuremberg, Germany.

Dr. Schett, who was not involved in the study, added that patients with more active arthritis may be more likely than those with less active disease to receive anti-TNF treatment, and so these patients may already be at increased risk for lymphoma.

Indeed, recent data from the British Society for Rheumatology Biologics Register (BSRBR) have shown that the risk of cancer is almost doubled in patients with RA compared with the general population before they are even given biologics (Rheumatology News, May 2011, p. 1).

"There is an increased risk of cancer in patients with rheumatoid arthritis because of the disease itself," agreed study investigator Dr. Dreyer in an interview. In particular, there was an increased risk of lung cancer in Danish patients because of smoking, said Dr. Dreyer, who is a rheumatologist at Gentofte Hospital in Copenhagen.

Dr. Merete Lund Hetland, a consultant rheumatologist from Glostrup University Hospital in Copenhagen and chair of the Danish register, added in an interview: "I think as a rheumatologist you would always tell your patient, ‘Well, we don’t think there is an increased risk, but there’s always a risk, so you should tell us if you experience any signs or symptoms [that might indicate cancer].’ "

Putting the cancer risk in further context, Dr. Dreyer noted that the risk of infection was higher than that of malignancy, and that of course the benefits of biologic treatment would probably outweigh the risk of malignancy in the majority of patients.

DANBIO (Dansk Reumatologisk Database) was set up in 2000 to prospectively follow all patients starting treatment with anti-TNFs for their arthritis in Denmark. Enrollment in the register is mandatory and included more than 13,500 patients with all types of inflammatory arthritis up until the data cut for the analysis of 2008. Of the enrolled patients, 5,598 had received treatment with anti-TNF agents and 8,101 had not. Two-thirds of patients had rheumatoid arthritis.

To assess cancer risk, data from DANBIO were linked to the Danish Cancer Registry, with a total of 181 first cancers occurring in patients treated with biologics and 132 in those who were not given biologics.

The risk of cancer was the same for men and women, did not increase with the cumulative duration of active treatment, and was independent of the anti-TNF agent used (primarily infliximab, etanercept, and adalimumab).

Similar to other European biologics registers, DANBIO is funded by research grants from all the major players in the biologics market in Denmark. These grants run through the Danish Rheumatism Association and the Danish Cancer Society, and the sponsors have no direct access or influence on how the registry data are collected, analyzed, or published.

"All companies are involved. They all pay the same amount, and we would monitor all drugs regardless of whether there was a sponsor or not," Dr. Hetland said.

The DANBIO team plans to examine the association between biologic treatment and malignancy further, looking at the subtypes of cancer that develop. The team also plans to investigate in more detail the different types of cancer that develop by the type of arthritis.

DANBIO is financially supported by grants from the Danish Rheumatism Association and the Danish Cancer Society. Dr. Hetland has acted as a consultant to Roche, and has received grants and research support on behalf of DANBIO from Abbott, BMS, Centocor, Roche, Schering-Plough, UCB-Nordic, and Wyeth. Dr. Dreyer had no disclosures. Dr. Schett was not involved in the study.