EULAR (European League Against Rheumatism): 2011 Congress

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.

"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 [physician] 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.

"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 [physician] 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.

"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 [physician] 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 – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

LONDON – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

LONDON – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

LONDON – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

LONDON – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

LONDON – Gout is an independent risk factor for acute myocardial infarction, even among younger patients and those without cardiovascular risk factors, according to Dr. Chang-Fu Kuo, who presented a late-breaking report at the Annual European Congress of Rheumatology.

The risk for acute MI was 23% higher among gout patients than the general population, judging from an analysis of a large Taiwanese database. Among individuals aged 20-44 years old and those without additional cardiovascular risk factors, the risk of acute MI was increased by 59% and 76%, respectively, reported Dr. Kuo of Chang Gung Memorial Hospital, Taipei, Taiwan.

To investigate the risk of acute MI associated with gout, Dr. Kuo and colleagues analyzed the 2000 Taiwan National Health Insurance database, which is a representative sampling cohort of the general population. Specifically, the investigators compared rates of first hospital admission for acute MI among gout and nongout patients aged 20 years or older. Of the 704,503 individuals included in the cohort (mean age, 42.73 years), 26,566 were diagnosed and treated for gout in 1996-1999, Dr. Kuo said. Compared with the nongout patients, "the gout patients were significantly older, with a mean age of 55.4 years, and they were significantly more likely to have diabetes and hypertension," he said.

The investigators followed the cohort from January 2000 through December 2008, for a total of 5.6 million patient-years of follow-up. During this period, 3,718 patients were hospitalized for acute MI, including 463 patients with gout. Of these events, 299 were fatal, including 35 in gout patients, Dr. Kuo said. "The incidence of acute [MI] in gout patients was 2.20 per 1,000 patient years and was significantly higher than in nongout patients, which was 0.60," he said.

In the multivariate model adjusted for age, sex, diabetes, hypertension, coronary heart disease, stroke, and end-stage renal disease, the respective hazard ratios for all acute MI and nonfatal acute MI in gout patients were 1.23 and 1.26, Dr. Kuo reported. "In patients without cardiovascular risk factors, the hazard ratio for all acute [MI] was 1.84, and for nonfatal acute [MI] was 1.80," he said, and when assessed by age, the respective hazard ratios for gout patients aged 20-44 years, 45-59 years, and 60 years or older were 1.59, 1.24, and 1.11.

The multivariate model was not adjusted for hyperlipidemia, which has been associated with gout, Dr. Kuo said, acknowledging that elevated lipid levels could play an important role in the increased cardiovascular risks observed in the gout patients.

Although the increased risk of acute MI associated with gout has been previously reported, "the risk in younger patients and those with low risk profiles hasn’t previously been established," Dr. Kuo explained. The finding that gout is an independent risk factor for the occurrence of acute MI – particularly nonfatal acute MI – among young, low-risk patients suggests the need for "vigilant cardiovascular monitoring" of these patients, he stressed.

Dr. Kuo reported having no conflicts of interest to disclose.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

It may be appropriate to forgo dual-energy x-ray absorptiometry scanning and instead use body mass index to rule out osteoporosis in some obese patients, according to the findings of a large study presented by Dr. Thomas Nelson at the annual European Congress of Rheumatology.

Patients in the study with a BMI greater than 30 kg/m², age younger than 70 years, and few clinical risk factors for osteoporosis had a low prevalence of osteoporosis, compared with the general population, said Dr. Nelson, a rheumatologist at the Royal Lancaster (England) Infirmary.

For example, after correction for risk factors including age, sex, index of deprivation, and a number of clinical risk factors (such as recurrent falls, smoking, rheumatoid arthritis, corticosteroid use, maternal hip fracture, excessive consumption of alcohol, fragility fractures, and secondary osteoporosis), a low BMI in 10,657 patients who were randomly assigned to a reference cohort was found to be an independent predictor of osteoporosis (area under the ROC curve, 0.72 for total hip osteoporosis and 0.67 for lumbar spine osteoporosis).

Use of a BMI threshold "of approximately 30 was found to give 93.6% sensitivity for hip osteoporosis and 90.8% for lumbar spine osteoporosis," Dr. Nelson said.

Thus, a hypothesis was formed that in obese patients, osteoporosis could be excluded without dual-energy x-ray absorptiometry (DXA), and only 6.4% of patients with hip osteoporosis – and 9.2% with lumbar spine osteoporosis – would be missed.

When the hypothesis was applied in a validation cohort of 5,329 patients, hip osteoporosis was seen in 2.7% of obese patients, and lumbar spine osteoporosis was observed in 7.2%, compared with 10.7% and 16.6%, respectively, in the entire cohort.

Among those younger than age 70 years, only 0.7% and 5.4% had hip and lumbar spine osteoporosis, respectively.

Patients in the study were scanned between June 2004 and August 2010. They were randomly assigned to the reference or validation cohorts. The cohorts did not differ in regard to age, sex, BMI, body fat percentage, deprivation, or number of clinical risk factors. About 23% of patients in both groups were obese.

Should the suggestion that DXA scanning is unnecessary for ruling out osteoporosis in obese patients be validated in other populations, the finding could help to minimize radiation exposure, improve convenience, and lower costs for many patients. However, it is plausible that a greater bone mineral density is required by obese patients, compared with nonobese patients, to avoid symptoms and fracture risk associated with osteoporosis, and further research is required in this area, he concluded.

Dr. Nelson had no disclosures to report.

It may be appropriate to forgo dual-energy x-ray absorptiometry scanning and instead use body mass index to rule out osteoporosis in some obese patients, according to the findings of a large study presented by Dr. Thomas Nelson at the annual European Congress of Rheumatology.

Patients in the study with a BMI greater than 30 kg/m², age younger than 70 years, and few clinical risk factors for osteoporosis had a low prevalence of osteoporosis, compared with the general population, said Dr. Nelson, a rheumatologist at the Royal Lancaster (England) Infirmary.

For example, after correction for risk factors including age, sex, index of deprivation, and a number of clinical risk factors (such as recurrent falls, smoking, rheumatoid arthritis, corticosteroid use, maternal hip fracture, excessive consumption of alcohol, fragility fractures, and secondary osteoporosis), a low BMI in 10,657 patients who were randomly assigned to a reference cohort was found to be an independent predictor of osteoporosis (area under the ROC curve, 0.72 for total hip osteoporosis and 0.67 for lumbar spine osteoporosis).

Use of a BMI threshold "of approximately 30 was found to give 93.6% sensitivity for hip osteoporosis and 90.8% for lumbar spine osteoporosis," Dr. Nelson said.

Thus, a hypothesis was formed that in obese patients, osteoporosis could be excluded without dual-energy x-ray absorptiometry (DXA), and only 6.4% of patients with hip osteoporosis – and 9.2% with lumbar spine osteoporosis – would be missed.

When the hypothesis was applied in a validation cohort of 5,329 patients, hip osteoporosis was seen in 2.7% of obese patients, and lumbar spine osteoporosis was observed in 7.2%, compared with 10.7% and 16.6%, respectively, in the entire cohort.

Among those younger than age 70 years, only 0.7% and 5.4% had hip and lumbar spine osteoporosis, respectively.

Patients in the study were scanned between June 2004 and August 2010. They were randomly assigned to the reference or validation cohorts. The cohorts did not differ in regard to age, sex, BMI, body fat percentage, deprivation, or number of clinical risk factors. About 23% of patients in both groups were obese.

Should the suggestion that DXA scanning is unnecessary for ruling out osteoporosis in obese patients be validated in other populations, the finding could help to minimize radiation exposure, improve convenience, and lower costs for many patients. However, it is plausible that a greater bone mineral density is required by obese patients, compared with nonobese patients, to avoid symptoms and fracture risk associated with osteoporosis, and further research is required in this area, he concluded.

Dr. Nelson had no disclosures to report.

It may be appropriate to forgo dual-energy x-ray absorptiometry scanning and instead use body mass index to rule out osteoporosis in some obese patients, according to the findings of a large study presented by Dr. Thomas Nelson at the annual European Congress of Rheumatology.

Patients in the study with a BMI greater than 30 kg/m², age younger than 70 years, and few clinical risk factors for osteoporosis had a low prevalence of osteoporosis, compared with the general population, said Dr. Nelson, a rheumatologist at the Royal Lancaster (England) Infirmary.

For example, after correction for risk factors including age, sex, index of deprivation, and a number of clinical risk factors (such as recurrent falls, smoking, rheumatoid arthritis, corticosteroid use, maternal hip fracture, excessive consumption of alcohol, fragility fractures, and secondary osteoporosis), a low BMI in 10,657 patients who were randomly assigned to a reference cohort was found to be an independent predictor of osteoporosis (area under the ROC curve, 0.72 for total hip osteoporosis and 0.67 for lumbar spine osteoporosis).

Use of a BMI threshold "of approximately 30 was found to give 93.6% sensitivity for hip osteoporosis and 90.8% for lumbar spine osteoporosis," Dr. Nelson said.

Thus, a hypothesis was formed that in obese patients, osteoporosis could be excluded without dual-energy x-ray absorptiometry (DXA), and only 6.4% of patients with hip osteoporosis – and 9.2% with lumbar spine osteoporosis – would be missed.

When the hypothesis was applied in a validation cohort of 5,329 patients, hip osteoporosis was seen in 2.7% of obese patients, and lumbar spine osteoporosis was observed in 7.2%, compared with 10.7% and 16.6%, respectively, in the entire cohort.

Among those younger than age 70 years, only 0.7% and 5.4% had hip and lumbar spine osteoporosis, respectively.

Patients in the study were scanned between June 2004 and August 2010. They were randomly assigned to the reference or validation cohorts. The cohorts did not differ in regard to age, sex, BMI, body fat percentage, deprivation, or number of clinical risk factors. About 23% of patients in both groups were obese.

Should the suggestion that DXA scanning is unnecessary for ruling out osteoporosis in obese patients be validated in other populations, the finding could help to minimize radiation exposure, improve convenience, and lower costs for many patients. However, it is plausible that a greater bone mineral density is required by obese patients, compared with nonobese patients, to avoid symptoms and fracture risk associated with osteoporosis, and further research is required in this area, he concluded.

Dr. Nelson had no disclosures to report.

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 3e (Evidence, Expertise, Exchange) Initiative is a multinational collaboration that aims to promote evidence-based medicine in rheumatology. For recommendations that address pain management by pharmacotherapy in inflammatory arthritis (IA), 89 of 453 rheumatologists from 17 countries who were involved in the initiative developed a list of 10 top clinical questions regarding medical treatment for IA pain.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.

Patients with rheumatoid arthritis who received 3 months of treatment with the investigational Janus kinase inhibitor tofacitinib had clinically significant improvements in patient-reported outcomes, compared with those who were given placebo, according to Dr. Vibeke Strand, who reported the 3-month results of a 6-month, phase III trial on May 26.

"I see this drug as being everything that a biologic is. ...There are a lot of places where biologics are not very accessible. ... The data look quite comparable to biologics," Dr. Strand said in an interview.

The study marks the first of five pivotal, phase III, randomized, placebo-controlled trials planned for tofacitinib (CP-690-550), Dr. Strand said in an interview. She described tofacitinib as "the first of several Janus kinase and Syk kinase inhibitors that are promising oral disease-modifying antirheumatic drugs with onset of effect that is rapid and magnitude of effect similar to anti–[tumor necrosis factor] therapies," said Dr. Strand of the division of immunology/rheumatology at Stanford (Calif.) University. Tofacitinib "has been studied vs. monotherapy adalimumab in phase II."

For the current 6-month trial, 610 rheumatoid arthritis (RA) patients were randomized to one of three treatments: tofacitinib 5 mg b.i.d., tofacitinib 10 mg b.i.d., or placebo, all as monotherapy. Patients on placebo were advanced to either tofacitinib 5 mg b.i.d. or tofacitinib 10 mg b.i.d. after month 3. The mean age of the patients was 51 years, and 87% were women.

In her presentation, Dr. Strand reported change-from-baseline results on several patient-reported outcomes at 3 months, including Patient Global Assessment of disease activity on a visual analog scale, pain on a visual analog scale, physical function by the HAQ-DI (Health Assessment Questionnaire–Disability Index), and health-related quality of life by the MOS SF-36 (Medical Outcomes Study 36-item Short Form Health Survey).

Improvements were reported as least square means of changes from baseline. At 3 months, treatment with tofacitinib monotherapy resulted in statistically significant and clinically meaningful improvements, compared with placebo, in all patient-reported outcomes except sleep improvement in the tofacitinib 5-mg group.

Mean Patient Global Assessment scores achieved a minimally clinically important difference (MCID) relative to baseline in 73% of the patients taking 5 mg (number needed to treat, 4), in 75% of patients taking10 mg (NNT, 3.8), and in 48% of the placebo group.

Patients’ pain scores showed an MCID relative to baseline in 70% of the patients on 5 mg (NNT, 4.6), in 77% of the patients on 10 mg (NNT, 3.5), and in 48% of the patients on placebo.

Physical function scores on the HAQ-DI showed an MCID relative to baseline in 61% of the patients on 5 mg (NNT, 5.7), in 68% in patients taking 10 mg (NNT, 4), and in 43% of those on placebo.

The physical component scores on the MOS SF-36 were 2.63, 6.97, and 8.55, respectively. Physical component scores on the MOS SF-36 showed an MCID relative to baseline in 68% of the patients on 5 mg (NNT, 4.2), in 75% of the group on 10 mg (NNT, 3.2), and in 44% of those on placebo.

"Randomized, controlled trial data don’t always reflect what we see in the clinic, but this product has a large phase II database, and these findings are consistent with those data," Dr. Strand said. "Patients clearly have derived early and clinically meaningful benefit from treatment – in pain, fatigue, physical function, and ‘multidimensional function’ [as shown] in the SF-36 – which reflects improvements in those parameters, and not just physical and emotional well-being but also in social functioning and mental health."

Dr. Strand disclosed that she is a paid consultant to Pfizer but said that she received no support for preparation of the abstract or presentation.