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American College of Rheumatology (ACR): Annual Scientific Meeting
Pregabalin improves fibromyalgia pain with comorbid depression
SAN DIEGO – Pregabalin significantly improved fibromyalgia pain even in patients who were being treated for comorbid depression in a double-blind, crossover clinical trial.
The clinical relevance of this new finding lies in the fact that up to 70% of fibromyalgia patients have a lifetime history of depression, and about 25% are on antidepressant medication when they present for treatment of fibromyalgia. Yet all the studies that led to Food and Drug Administration approval of pregabalin (Lyrica) for treatment of fibromyalgia pain required that participants not be on antidepressant medication. Thus, there has been no information as to the effectiveness and safety of pregabalin in fibromyalgia patients on concomitant antidepressants for comorbid depression, Dr. Lesley M. Arnold explained at the annual meeting of the American College of Rheumatology.
She presented a 14-week, randomized, double-blind, multicenter study involving 197 patients who met the 1990 American College of Rheumatology criteria for fibromyalgia. All participants also carried a diagnosis of major depression, depression NOS (not otherwise specified), or dysthymia for which they were taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
This was a typical population of fibromyalgia patients: 93% were women, 94% white, with a mean age of 50 years. Their on-treatment depression was mild as evidenced by a baseline mean Hospital Anxiety and Depression Scale–Depression score of 8.0. They were randomized to 6 weeks of placebo or pregabalin started at 150 mg/day dosed twice daily and optimized over the first 3 weeks to either 300 or 450 mg/day as per the product labeling. Three-quarters of patients reached 450 mg/day. After the first 6 weeks of treatment, a 2-week washout period followed, then a switch to the alternate regimen for another 6 weeks.
The primary endpoint was change in mean self-reported pain score based on the average of daily pain scores for the previous 7 days. From a mean baseline pain score of 6.7 on a 0-10 scale, the score dropped to 4.84 on pregabalin, a significantly greater improvement than the 5.45 with placebo. The response to pregabalin was rapid: The improvement in pain scores became significant within the first week and was maintained to the study’s end, reported Dr. Arnold, professor of psychiatry and behavioral neuroscience and director of the Women’s Health Research Program at the University of Cincinnati.
Most patients would find this roughly 28% reduction in pain with pregabalin to be clinically meaningful, she added. In addition, secondary endpoints in the study now being analyzed address improvement in function and global quality of life. Those results will be available within several months.
Pregabalin has a well-established safety profile. No surprises were noted when the drug was used with concomitant antidepressants. The most frequently reported adverse events were dizziness in 28% of patients and sleepiness in 20%. Discontinuation because of adverse events occurred in 6.1% of patients on pregabalin and 3.4% on placebo.
Elsewhere at the ACR meeting, Dr. Arnold presented the results of a phase III, randomized trial in which a novel, investigational, once-daily, controlled-release formulation of pregabalin outperformed placebo in 441 fibromyalgia patients.
Both studies were funded by Pfizer. Dr. Arnold reported receiving research grants from and serving as a consultant to the company.
SAN DIEGO – Pregabalin significantly improved fibromyalgia pain even in patients who were being treated for comorbid depression in a double-blind, crossover clinical trial.
The clinical relevance of this new finding lies in the fact that up to 70% of fibromyalgia patients have a lifetime history of depression, and about 25% are on antidepressant medication when they present for treatment of fibromyalgia. Yet all the studies that led to Food and Drug Administration approval of pregabalin (Lyrica) for treatment of fibromyalgia pain required that participants not be on antidepressant medication. Thus, there has been no information as to the effectiveness and safety of pregabalin in fibromyalgia patients on concomitant antidepressants for comorbid depression, Dr. Lesley M. Arnold explained at the annual meeting of the American College of Rheumatology.
She presented a 14-week, randomized, double-blind, multicenter study involving 197 patients who met the 1990 American College of Rheumatology criteria for fibromyalgia. All participants also carried a diagnosis of major depression, depression NOS (not otherwise specified), or dysthymia for which they were taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
This was a typical population of fibromyalgia patients: 93% were women, 94% white, with a mean age of 50 years. Their on-treatment depression was mild as evidenced by a baseline mean Hospital Anxiety and Depression Scale–Depression score of 8.0. They were randomized to 6 weeks of placebo or pregabalin started at 150 mg/day dosed twice daily and optimized over the first 3 weeks to either 300 or 450 mg/day as per the product labeling. Three-quarters of patients reached 450 mg/day. After the first 6 weeks of treatment, a 2-week washout period followed, then a switch to the alternate regimen for another 6 weeks.
The primary endpoint was change in mean self-reported pain score based on the average of daily pain scores for the previous 7 days. From a mean baseline pain score of 6.7 on a 0-10 scale, the score dropped to 4.84 on pregabalin, a significantly greater improvement than the 5.45 with placebo. The response to pregabalin was rapid: The improvement in pain scores became significant within the first week and was maintained to the study’s end, reported Dr. Arnold, professor of psychiatry and behavioral neuroscience and director of the Women’s Health Research Program at the University of Cincinnati.
Most patients would find this roughly 28% reduction in pain with pregabalin to be clinically meaningful, she added. In addition, secondary endpoints in the study now being analyzed address improvement in function and global quality of life. Those results will be available within several months.
Pregabalin has a well-established safety profile. No surprises were noted when the drug was used with concomitant antidepressants. The most frequently reported adverse events were dizziness in 28% of patients and sleepiness in 20%. Discontinuation because of adverse events occurred in 6.1% of patients on pregabalin and 3.4% on placebo.
Elsewhere at the ACR meeting, Dr. Arnold presented the results of a phase III, randomized trial in which a novel, investigational, once-daily, controlled-release formulation of pregabalin outperformed placebo in 441 fibromyalgia patients.
Both studies were funded by Pfizer. Dr. Arnold reported receiving research grants from and serving as a consultant to the company.
SAN DIEGO – Pregabalin significantly improved fibromyalgia pain even in patients who were being treated for comorbid depression in a double-blind, crossover clinical trial.
The clinical relevance of this new finding lies in the fact that up to 70% of fibromyalgia patients have a lifetime history of depression, and about 25% are on antidepressant medication when they present for treatment of fibromyalgia. Yet all the studies that led to Food and Drug Administration approval of pregabalin (Lyrica) for treatment of fibromyalgia pain required that participants not be on antidepressant medication. Thus, there has been no information as to the effectiveness and safety of pregabalin in fibromyalgia patients on concomitant antidepressants for comorbid depression, Dr. Lesley M. Arnold explained at the annual meeting of the American College of Rheumatology.
She presented a 14-week, randomized, double-blind, multicenter study involving 197 patients who met the 1990 American College of Rheumatology criteria for fibromyalgia. All participants also carried a diagnosis of major depression, depression NOS (not otherwise specified), or dysthymia for which they were taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
This was a typical population of fibromyalgia patients: 93% were women, 94% white, with a mean age of 50 years. Their on-treatment depression was mild as evidenced by a baseline mean Hospital Anxiety and Depression Scale–Depression score of 8.0. They were randomized to 6 weeks of placebo or pregabalin started at 150 mg/day dosed twice daily and optimized over the first 3 weeks to either 300 or 450 mg/day as per the product labeling. Three-quarters of patients reached 450 mg/day. After the first 6 weeks of treatment, a 2-week washout period followed, then a switch to the alternate regimen for another 6 weeks.
The primary endpoint was change in mean self-reported pain score based on the average of daily pain scores for the previous 7 days. From a mean baseline pain score of 6.7 on a 0-10 scale, the score dropped to 4.84 on pregabalin, a significantly greater improvement than the 5.45 with placebo. The response to pregabalin was rapid: The improvement in pain scores became significant within the first week and was maintained to the study’s end, reported Dr. Arnold, professor of psychiatry and behavioral neuroscience and director of the Women’s Health Research Program at the University of Cincinnati.
Most patients would find this roughly 28% reduction in pain with pregabalin to be clinically meaningful, she added. In addition, secondary endpoints in the study now being analyzed address improvement in function and global quality of life. Those results will be available within several months.
Pregabalin has a well-established safety profile. No surprises were noted when the drug was used with concomitant antidepressants. The most frequently reported adverse events were dizziness in 28% of patients and sleepiness in 20%. Discontinuation because of adverse events occurred in 6.1% of patients on pregabalin and 3.4% on placebo.
Elsewhere at the ACR meeting, Dr. Arnold presented the results of a phase III, randomized trial in which a novel, investigational, once-daily, controlled-release formulation of pregabalin outperformed placebo in 441 fibromyalgia patients.
Both studies were funded by Pfizer. Dr. Arnold reported receiving research grants from and serving as a consultant to the company.
AT THE ACR ANNUAL MEETING
Major finding: Pregabalin resulted in an improvement in mean pain scores from 6.7 at baseline to 4.84 in fibromyalgia patients on antidepressant medication for comorbid depression.
Data source: A 14-week, randomized, double-blind, prospective, multicenter, placebo-controlled crossover study involving 197 fibromyalgia patients on antidepressant medication for comorbid depression.
Disclosures: The study was sponsored by Pfizer. The presenter has received research grants from and serves as a consultant to the company.
Orthopedic surgery among RA patients declining, study finds
SAN DIEGO – The overall proportion of rheumatoid arthritis patients undergoing orthopedic surgery is declining as intensive pharmacologic intervention with agents such as biologics play an increasingly prominent role in the treatment of the inflammatory disease, judging from results from a large, long-term study.
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat and his associates enrolled 2,342 men and women from RA patient registries in Sweden who filled out questionnaires including visual analog scales for general health and pain, and the Health Assessment Questionnaire (HAQ) in 1997, 2002, 2005, and 2009.
The response rate ranged from 62% to 74%, and the researchers linked responses to Swedish national health registry records to correlate the data with records of inpatient and outpatient surgeries, as well as the use of biologics. They went on to evaluate the incidence rate of orthopedic surgery in three time periods: from 1998-2001 (time period A), 2002-2006 (time period B), and 2007-2011 (time period C).
Dr. Hekmat, a rheumatologist and a PhD fellow at Malmö University, Sweden, reported that between 1998 and 2011 the incidence of all orthopedic procedures performed was 82.3 per 1,000 person-years. Significant declines were observed over the three time periods studied. For example, the incidence of any orthopedic surgery declined from 94.6 per 1,000 person-years in time period A to 82.6 per 1,000 person-years in time period B, and 71.8 per 1,000 person-years in time period C (P less than .001).
A similar association was observed for hip surgery alone (which fell from 27.8 per 1,000 person-years in time period A to 17.6 per 1,000 person-years in time period C; P less than .001). The incidence of orthopedic surgery on small joints such as hands, wrists, feet, and ankles fell from 43.8 per 1,000 person-years in time period A to 30.5 per 1,000 person-years in time period C (P less than .001).
No significant decline occurred in the incidence of knee surgeries performed during the study period. This actually rose slightly from 12.3 per 1,000 person-years in time period A to 12.9 per 1,000 person-years in time period C (P = .759).
Independent predictors of undergoing any orthopedic surgery included being female (hazard ratio 1.50) and having greater disability as measured by the HAQ (HR 1.37).
Dr. Hekmat speculated that the rate of orthopedic surgery was reduced by early intensive treatment in patients with RA, since the time period studied coincided with the increased use of pharmacologic interventions. "In this cohort we are targeting the patients more aggressively," he said. "It’s not wrong to guess that this decline may lead to better [disease] management."
Dr. Hekmat said that he had no relevant financial conflicts to disclose.
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat, Health Assessment Questionnaire, Malmö University, Sweden, orthopedic procedures,
SAN DIEGO – The overall proportion of rheumatoid arthritis patients undergoing orthopedic surgery is declining as intensive pharmacologic intervention with agents such as biologics play an increasingly prominent role in the treatment of the inflammatory disease, judging from results from a large, long-term study.
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat and his associates enrolled 2,342 men and women from RA patient registries in Sweden who filled out questionnaires including visual analog scales for general health and pain, and the Health Assessment Questionnaire (HAQ) in 1997, 2002, 2005, and 2009.
The response rate ranged from 62% to 74%, and the researchers linked responses to Swedish national health registry records to correlate the data with records of inpatient and outpatient surgeries, as well as the use of biologics. They went on to evaluate the incidence rate of orthopedic surgery in three time periods: from 1998-2001 (time period A), 2002-2006 (time period B), and 2007-2011 (time period C).
Dr. Hekmat, a rheumatologist and a PhD fellow at Malmö University, Sweden, reported that between 1998 and 2011 the incidence of all orthopedic procedures performed was 82.3 per 1,000 person-years. Significant declines were observed over the three time periods studied. For example, the incidence of any orthopedic surgery declined from 94.6 per 1,000 person-years in time period A to 82.6 per 1,000 person-years in time period B, and 71.8 per 1,000 person-years in time period C (P less than .001).
A similar association was observed for hip surgery alone (which fell from 27.8 per 1,000 person-years in time period A to 17.6 per 1,000 person-years in time period C; P less than .001). The incidence of orthopedic surgery on small joints such as hands, wrists, feet, and ankles fell from 43.8 per 1,000 person-years in time period A to 30.5 per 1,000 person-years in time period C (P less than .001).
No significant decline occurred in the incidence of knee surgeries performed during the study period. This actually rose slightly from 12.3 per 1,000 person-years in time period A to 12.9 per 1,000 person-years in time period C (P = .759).
Independent predictors of undergoing any orthopedic surgery included being female (hazard ratio 1.50) and having greater disability as measured by the HAQ (HR 1.37).
Dr. Hekmat speculated that the rate of orthopedic surgery was reduced by early intensive treatment in patients with RA, since the time period studied coincided with the increased use of pharmacologic interventions. "In this cohort we are targeting the patients more aggressively," he said. "It’s not wrong to guess that this decline may lead to better [disease] management."
Dr. Hekmat said that he had no relevant financial conflicts to disclose.
SAN DIEGO – The overall proportion of rheumatoid arthritis patients undergoing orthopedic surgery is declining as intensive pharmacologic intervention with agents such as biologics play an increasingly prominent role in the treatment of the inflammatory disease, judging from results from a large, long-term study.
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat and his associates enrolled 2,342 men and women from RA patient registries in Sweden who filled out questionnaires including visual analog scales for general health and pain, and the Health Assessment Questionnaire (HAQ) in 1997, 2002, 2005, and 2009.
The response rate ranged from 62% to 74%, and the researchers linked responses to Swedish national health registry records to correlate the data with records of inpatient and outpatient surgeries, as well as the use of biologics. They went on to evaluate the incidence rate of orthopedic surgery in three time periods: from 1998-2001 (time period A), 2002-2006 (time period B), and 2007-2011 (time period C).
Dr. Hekmat, a rheumatologist and a PhD fellow at Malmö University, Sweden, reported that between 1998 and 2011 the incidence of all orthopedic procedures performed was 82.3 per 1,000 person-years. Significant declines were observed over the three time periods studied. For example, the incidence of any orthopedic surgery declined from 94.6 per 1,000 person-years in time period A to 82.6 per 1,000 person-years in time period B, and 71.8 per 1,000 person-years in time period C (P less than .001).
A similar association was observed for hip surgery alone (which fell from 27.8 per 1,000 person-years in time period A to 17.6 per 1,000 person-years in time period C; P less than .001). The incidence of orthopedic surgery on small joints such as hands, wrists, feet, and ankles fell from 43.8 per 1,000 person-years in time period A to 30.5 per 1,000 person-years in time period C (P less than .001).
No significant decline occurred in the incidence of knee surgeries performed during the study period. This actually rose slightly from 12.3 per 1,000 person-years in time period A to 12.9 per 1,000 person-years in time period C (P = .759).
Independent predictors of undergoing any orthopedic surgery included being female (hazard ratio 1.50) and having greater disability as measured by the HAQ (HR 1.37).
Dr. Hekmat speculated that the rate of orthopedic surgery was reduced by early intensive treatment in patients with RA, since the time period studied coincided with the increased use of pharmacologic interventions. "In this cohort we are targeting the patients more aggressively," he said. "It’s not wrong to guess that this decline may lead to better [disease] management."
Dr. Hekmat said that he had no relevant financial conflicts to disclose.
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat, Health Assessment Questionnaire, Malmö University, Sweden, orthopedic procedures,
In an ongoing population-based study presented at the annual meeting of the American College of Rheumatology, Dr. Korosh Hekmat, Health Assessment Questionnaire, Malmö University, Sweden, orthopedic procedures,
AT THE ACR ANNUAL MEETING
Major finding: The incidence of any orthopedic surgery among rheumatoid arthritis patients declined from 94.6 per 1,000 person-years in 1998-2001 to 82.6 per 1,000 person-years in 2002-2016 and 71.8 per 1,000 person-years in 2007-2011 (P less than .001).
Data source: A study of 2,342 men and women from RA patient registries in Sweden who filled out questionnaires including visual analog scales for general health and pain, and the Health Assessment Questionnaire in 1997, 2002, 2005, and 2009.
Disclosures: Dr. Hekmat said that he had no relevant financial conflicts to disclose.
Early aggressive therapy in JIA brings prolonged disease inactivation
SAN DIEGO – Starting aggressive multidrug therapy within the first several months after children were diagnosed with severe polyarticular juvenile idiopathic arthritis resulted in a "phenomenal" rate of clinical inactive disease, which occurred faster and was sustained longer than with high-dose methotrexate monotherapy in a randomized, double-blind, multicenter clinical trial.
"This is a groundbreaking study. This is the first-ever study in children that has used clinical inactive disease as the primary endpoint. And it showed that clinical inactive disease – or remission, if you’d like – is achievable if you treat early and aggressively," declared Dr. Carol A. Wallace, professor of pediatrics at the University of Washington, Seattle, and rheumatology division chief at Seattle Children’s Hospital.
At the annual meeting of the American College of Rheumatology, she presented a new secondary analysis from the previously reported landmark Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA), in which 85 patients diagnosed a median of 4.2 months prior to enrollment were randomized double-blind to one of two treatment arms: combination therapy with subcutaneous methotrexate at 0.5 mg/kg per week, etanercept at 0.8 mg/kg per week, plus prednisolone at 0.5 mg/kg per day tapered to zero by 17 weeks; or subcutaneous methotrexate dosed identically plus double placebos (Arthritis Rheum. 2012;64:2012-21).
The group on multidrug therapy spent a median of 42% of days during the 12-month study in a state of clinical inactive disease, compared with 24% for patients who started on methotrexate alone. And those figures don’t convey the full impact of combination therapy. Seventeen of the 28 patients in the methotrexate monotherapy group who achieved clinical inactive disease did so only after undergoing a protocol-mandated switch to open-label combination therapy because they failed to receive an ACR 70 response within the first 4 months, yet in the intent-to-treat analysis those 17 patients were counted in the methotrexate-alone group.
The term "clinical inactive disease" is defined stringently in pediatric rheumatology, Dr. Wallace explained. It requires that a patient must have zero joints with active arthritis, no elevation in ESR, no uveitis, a Physician Global Assessment score of 0 on a 0-10 scale, and no fever, rash, hepatosplenomegaly, or lymphadenopathy.
The fact that 68% of study patients achieved clinical inactive disease at some point is particularly impressive in light of their high burden of disease, Dr. Wallace observed. Their baseline Physician Global Assessment score was 7, and nearly 40% of subjects were rheumatoid factor positive.
A major goal in the secondary analysis was to identify predictors of a favorable treatment response. The investigators found two. One was time to treatment. It was a linear relationship: The earlier the treatment began, the more time patients spent in a state of clinical inactive disease. Those who started treatment having a disease duration of 3 months or less had clinical inactive disease at a median of 40% of clinic visits, regardless of treatment arm, while patients who began therapy with a disease duration of more than 3 months had clinical inactive disease at only 11% of visits.
The other predictor of a favorable response was achieving an ACR 70 response at 4 months, regardless of the treatment regimen employed. Among 49 patients who did so, 86% attained clinical inactive disease during the 12-month study, compared with a 44% rate among those who did not achieve the early ACR 70. Nine patients in the multidrug therapy arm and three on methotrexate monotherapy achieved a complete remission, defined as 6 months of continuous clinical inactive disease; all 12 of these patients had an ACR 70 response at 4 months.
Side effects in the two treatment groups were similarly uncommon.
The investigators are now attempting to learn whether the immune system of successfully treated children with juvenile idiopathic arthritis eventually returns to normal, making it safe to discontinue medications. The final word isn’t in yet, but Dr. Wallace is doubtful.
"At least 50% of children do flare when their medications are stopped, and they don’t always achieve the same level of disease response the second time around," said the pediatric rheumatologist.
The TREAT-JIA trial was funded by the National Institute of Allergy and Infectious Diseases and the Howe Endowment for Juvenile Idiopathic Arthritis Research. Dr. Wallace reported having no financial conflicts.
SAN DIEGO – Starting aggressive multidrug therapy within the first several months after children were diagnosed with severe polyarticular juvenile idiopathic arthritis resulted in a "phenomenal" rate of clinical inactive disease, which occurred faster and was sustained longer than with high-dose methotrexate monotherapy in a randomized, double-blind, multicenter clinical trial.
"This is a groundbreaking study. This is the first-ever study in children that has used clinical inactive disease as the primary endpoint. And it showed that clinical inactive disease – or remission, if you’d like – is achievable if you treat early and aggressively," declared Dr. Carol A. Wallace, professor of pediatrics at the University of Washington, Seattle, and rheumatology division chief at Seattle Children’s Hospital.
At the annual meeting of the American College of Rheumatology, she presented a new secondary analysis from the previously reported landmark Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA), in which 85 patients diagnosed a median of 4.2 months prior to enrollment were randomized double-blind to one of two treatment arms: combination therapy with subcutaneous methotrexate at 0.5 mg/kg per week, etanercept at 0.8 mg/kg per week, plus prednisolone at 0.5 mg/kg per day tapered to zero by 17 weeks; or subcutaneous methotrexate dosed identically plus double placebos (Arthritis Rheum. 2012;64:2012-21).
The group on multidrug therapy spent a median of 42% of days during the 12-month study in a state of clinical inactive disease, compared with 24% for patients who started on methotrexate alone. And those figures don’t convey the full impact of combination therapy. Seventeen of the 28 patients in the methotrexate monotherapy group who achieved clinical inactive disease did so only after undergoing a protocol-mandated switch to open-label combination therapy because they failed to receive an ACR 70 response within the first 4 months, yet in the intent-to-treat analysis those 17 patients were counted in the methotrexate-alone group.
The term "clinical inactive disease" is defined stringently in pediatric rheumatology, Dr. Wallace explained. It requires that a patient must have zero joints with active arthritis, no elevation in ESR, no uveitis, a Physician Global Assessment score of 0 on a 0-10 scale, and no fever, rash, hepatosplenomegaly, or lymphadenopathy.
The fact that 68% of study patients achieved clinical inactive disease at some point is particularly impressive in light of their high burden of disease, Dr. Wallace observed. Their baseline Physician Global Assessment score was 7, and nearly 40% of subjects were rheumatoid factor positive.
A major goal in the secondary analysis was to identify predictors of a favorable treatment response. The investigators found two. One was time to treatment. It was a linear relationship: The earlier the treatment began, the more time patients spent in a state of clinical inactive disease. Those who started treatment having a disease duration of 3 months or less had clinical inactive disease at a median of 40% of clinic visits, regardless of treatment arm, while patients who began therapy with a disease duration of more than 3 months had clinical inactive disease at only 11% of visits.
The other predictor of a favorable response was achieving an ACR 70 response at 4 months, regardless of the treatment regimen employed. Among 49 patients who did so, 86% attained clinical inactive disease during the 12-month study, compared with a 44% rate among those who did not achieve the early ACR 70. Nine patients in the multidrug therapy arm and three on methotrexate monotherapy achieved a complete remission, defined as 6 months of continuous clinical inactive disease; all 12 of these patients had an ACR 70 response at 4 months.
Side effects in the two treatment groups were similarly uncommon.
The investigators are now attempting to learn whether the immune system of successfully treated children with juvenile idiopathic arthritis eventually returns to normal, making it safe to discontinue medications. The final word isn’t in yet, but Dr. Wallace is doubtful.
"At least 50% of children do flare when their medications are stopped, and they don’t always achieve the same level of disease response the second time around," said the pediatric rheumatologist.
The TREAT-JIA trial was funded by the National Institute of Allergy and Infectious Diseases and the Howe Endowment for Juvenile Idiopathic Arthritis Research. Dr. Wallace reported having no financial conflicts.
SAN DIEGO – Starting aggressive multidrug therapy within the first several months after children were diagnosed with severe polyarticular juvenile idiopathic arthritis resulted in a "phenomenal" rate of clinical inactive disease, which occurred faster and was sustained longer than with high-dose methotrexate monotherapy in a randomized, double-blind, multicenter clinical trial.
"This is a groundbreaking study. This is the first-ever study in children that has used clinical inactive disease as the primary endpoint. And it showed that clinical inactive disease – or remission, if you’d like – is achievable if you treat early and aggressively," declared Dr. Carol A. Wallace, professor of pediatrics at the University of Washington, Seattle, and rheumatology division chief at Seattle Children’s Hospital.
At the annual meeting of the American College of Rheumatology, she presented a new secondary analysis from the previously reported landmark Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis (TREAT-JIA), in which 85 patients diagnosed a median of 4.2 months prior to enrollment were randomized double-blind to one of two treatment arms: combination therapy with subcutaneous methotrexate at 0.5 mg/kg per week, etanercept at 0.8 mg/kg per week, plus prednisolone at 0.5 mg/kg per day tapered to zero by 17 weeks; or subcutaneous methotrexate dosed identically plus double placebos (Arthritis Rheum. 2012;64:2012-21).
The group on multidrug therapy spent a median of 42% of days during the 12-month study in a state of clinical inactive disease, compared with 24% for patients who started on methotrexate alone. And those figures don’t convey the full impact of combination therapy. Seventeen of the 28 patients in the methotrexate monotherapy group who achieved clinical inactive disease did so only after undergoing a protocol-mandated switch to open-label combination therapy because they failed to receive an ACR 70 response within the first 4 months, yet in the intent-to-treat analysis those 17 patients were counted in the methotrexate-alone group.
The term "clinical inactive disease" is defined stringently in pediatric rheumatology, Dr. Wallace explained. It requires that a patient must have zero joints with active arthritis, no elevation in ESR, no uveitis, a Physician Global Assessment score of 0 on a 0-10 scale, and no fever, rash, hepatosplenomegaly, or lymphadenopathy.
The fact that 68% of study patients achieved clinical inactive disease at some point is particularly impressive in light of their high burden of disease, Dr. Wallace observed. Their baseline Physician Global Assessment score was 7, and nearly 40% of subjects were rheumatoid factor positive.
A major goal in the secondary analysis was to identify predictors of a favorable treatment response. The investigators found two. One was time to treatment. It was a linear relationship: The earlier the treatment began, the more time patients spent in a state of clinical inactive disease. Those who started treatment having a disease duration of 3 months or less had clinical inactive disease at a median of 40% of clinic visits, regardless of treatment arm, while patients who began therapy with a disease duration of more than 3 months had clinical inactive disease at only 11% of visits.
The other predictor of a favorable response was achieving an ACR 70 response at 4 months, regardless of the treatment regimen employed. Among 49 patients who did so, 86% attained clinical inactive disease during the 12-month study, compared with a 44% rate among those who did not achieve the early ACR 70. Nine patients in the multidrug therapy arm and three on methotrexate monotherapy achieved a complete remission, defined as 6 months of continuous clinical inactive disease; all 12 of these patients had an ACR 70 response at 4 months.
Side effects in the two treatment groups were similarly uncommon.
The investigators are now attempting to learn whether the immune system of successfully treated children with juvenile idiopathic arthritis eventually returns to normal, making it safe to discontinue medications. The final word isn’t in yet, but Dr. Wallace is doubtful.
"At least 50% of children do flare when their medications are stopped, and they don’t always achieve the same level of disease response the second time around," said the pediatric rheumatologist.
The TREAT-JIA trial was funded by the National Institute of Allergy and Infectious Diseases and the Howe Endowment for Juvenile Idiopathic Arthritis Research. Dr. Wallace reported having no financial conflicts.
AT THE ACR ANNUAL MEETING
Major finding: Children with polyarticular juvenile idiopathic arthritis who started on the combination of methotrexate, etanercept, and prednisolone within the first few months after diagnosis spent a median of 42% of a 12-month study in a state of clinical inactive disease, whereas for those assigned to methotrexate alone, the corresponding figure was 24%.
Data source: A randomized, double-blind, placebo-controlled, 15-center clinical trial involving 85 patients with polyarticular juvenile idiopathic arthritis of a median 4.2 months duration prior to enrollment.
Disclosures: The National Institute of Allergy and Infectious Diseases and the Howe Endowment for Juvenile Idiopathic Arthritis funded the study. Dr. Wallace reported having no financial conflicts.
Smoking has damaging impact in ankylosing spondylitis
SAN DIEGO – Smoking increases the effect of inflammation on x-ray damage in people with ankylosing spondylitis by more than fivefold, results from a Dutch study demonstrated. In addition, the effect is amplified by more than 13-fold in male smokers, compared with females who don’t smoke.
Those are the key findings from OASIS (Outcome in AS International Study), which followed ankylosing spondylitis patients for up to 12 years with biannual clinical assessments, including radiographs. Lead investigator Dr. Sofia Ramiro of the Academic Medical Center at the University of Amsterdam discussed the study during a press briefing at the annual meeting of the American College of Rheumatology.
Two reviewers independently scored the x-rays of 127 patients with ankylosing spondylitis according to the Modified Stoke Ankylosing Spondylitis Supine Score (mSASSS). Dr. Ramiro and her associates evaluated the relationship between the AS Disease Activity Score and x-ray damage over a period of 12 years by assessing the effect of inflammation at one point in time on the progression of damage 2 years later.
The mean age of the 127 patients was 41 years and 71% were male. Their mean symptom duration was 18 years, 82% were human leukocyte antigen B27 (HLA-B27) positive, and 40% were smokers.
Overall, smokers had a 5.5-fold higher effect of inflammation on x-ray damage, compared with nonsmokers, and male smokers had a 13.4-fold higher effect of inflammation on damage, compared with female nonsmokers. In addition, smokers with a short symptom duration – defined as those with fewer than 18 years of symptoms – had an 8.1-fold higher effect of inflammation on damage, compared with nonsmokers with long symptom duration.
"Smoking cessation, especially among young males, seems to be an important take-home message," Dr. Ramiro commented. "It will probably lead to less radiographic damage and to better long-term outcomes."
The press briefing’s moderator, Dr. Christie M. Bartels of the division of rheumatology at the University of Wisconsin in Madison, characterized the findings as "additional compelling evidence to say that smoking cessation would be an important process measure to look at in the rheumatology clinic, so that we can help our patients achieve their optimal outcomes."
As to the possible mechanism of action behind the relationship, Dr. Ramiro speculated that "it’s not really smoking itself that’s contributing to the worse outcomes. Smoking is increasing the impact of inflammation on radiographic damage. It’s inflammation that causes the damage."
In an interview, she acknowledged certain limitations of the study, including the fact that the sample size "is not large enough to split the data into several relevant subgroups. For instance, the number of females is rather small, as is the number of HLA-B27–negative males and females."
Dr. Ramiro said that she had no relevant financial conflicts to disclose.
SAN DIEGO – Smoking increases the effect of inflammation on x-ray damage in people with ankylosing spondylitis by more than fivefold, results from a Dutch study demonstrated. In addition, the effect is amplified by more than 13-fold in male smokers, compared with females who don’t smoke.
Those are the key findings from OASIS (Outcome in AS International Study), which followed ankylosing spondylitis patients for up to 12 years with biannual clinical assessments, including radiographs. Lead investigator Dr. Sofia Ramiro of the Academic Medical Center at the University of Amsterdam discussed the study during a press briefing at the annual meeting of the American College of Rheumatology.
Two reviewers independently scored the x-rays of 127 patients with ankylosing spondylitis according to the Modified Stoke Ankylosing Spondylitis Supine Score (mSASSS). Dr. Ramiro and her associates evaluated the relationship between the AS Disease Activity Score and x-ray damage over a period of 12 years by assessing the effect of inflammation at one point in time on the progression of damage 2 years later.
The mean age of the 127 patients was 41 years and 71% were male. Their mean symptom duration was 18 years, 82% were human leukocyte antigen B27 (HLA-B27) positive, and 40% were smokers.
Overall, smokers had a 5.5-fold higher effect of inflammation on x-ray damage, compared with nonsmokers, and male smokers had a 13.4-fold higher effect of inflammation on damage, compared with female nonsmokers. In addition, smokers with a short symptom duration – defined as those with fewer than 18 years of symptoms – had an 8.1-fold higher effect of inflammation on damage, compared with nonsmokers with long symptom duration.
"Smoking cessation, especially among young males, seems to be an important take-home message," Dr. Ramiro commented. "It will probably lead to less radiographic damage and to better long-term outcomes."
The press briefing’s moderator, Dr. Christie M. Bartels of the division of rheumatology at the University of Wisconsin in Madison, characterized the findings as "additional compelling evidence to say that smoking cessation would be an important process measure to look at in the rheumatology clinic, so that we can help our patients achieve their optimal outcomes."
As to the possible mechanism of action behind the relationship, Dr. Ramiro speculated that "it’s not really smoking itself that’s contributing to the worse outcomes. Smoking is increasing the impact of inflammation on radiographic damage. It’s inflammation that causes the damage."
In an interview, she acknowledged certain limitations of the study, including the fact that the sample size "is not large enough to split the data into several relevant subgroups. For instance, the number of females is rather small, as is the number of HLA-B27–negative males and females."
Dr. Ramiro said that she had no relevant financial conflicts to disclose.
SAN DIEGO – Smoking increases the effect of inflammation on x-ray damage in people with ankylosing spondylitis by more than fivefold, results from a Dutch study demonstrated. In addition, the effect is amplified by more than 13-fold in male smokers, compared with females who don’t smoke.
Those are the key findings from OASIS (Outcome in AS International Study), which followed ankylosing spondylitis patients for up to 12 years with biannual clinical assessments, including radiographs. Lead investigator Dr. Sofia Ramiro of the Academic Medical Center at the University of Amsterdam discussed the study during a press briefing at the annual meeting of the American College of Rheumatology.
Two reviewers independently scored the x-rays of 127 patients with ankylosing spondylitis according to the Modified Stoke Ankylosing Spondylitis Supine Score (mSASSS). Dr. Ramiro and her associates evaluated the relationship between the AS Disease Activity Score and x-ray damage over a period of 12 years by assessing the effect of inflammation at one point in time on the progression of damage 2 years later.
The mean age of the 127 patients was 41 years and 71% were male. Their mean symptom duration was 18 years, 82% were human leukocyte antigen B27 (HLA-B27) positive, and 40% were smokers.
Overall, smokers had a 5.5-fold higher effect of inflammation on x-ray damage, compared with nonsmokers, and male smokers had a 13.4-fold higher effect of inflammation on damage, compared with female nonsmokers. In addition, smokers with a short symptom duration – defined as those with fewer than 18 years of symptoms – had an 8.1-fold higher effect of inflammation on damage, compared with nonsmokers with long symptom duration.
"Smoking cessation, especially among young males, seems to be an important take-home message," Dr. Ramiro commented. "It will probably lead to less radiographic damage and to better long-term outcomes."
The press briefing’s moderator, Dr. Christie M. Bartels of the division of rheumatology at the University of Wisconsin in Madison, characterized the findings as "additional compelling evidence to say that smoking cessation would be an important process measure to look at in the rheumatology clinic, so that we can help our patients achieve their optimal outcomes."
As to the possible mechanism of action behind the relationship, Dr. Ramiro speculated that "it’s not really smoking itself that’s contributing to the worse outcomes. Smoking is increasing the impact of inflammation on radiographic damage. It’s inflammation that causes the damage."
In an interview, she acknowledged certain limitations of the study, including the fact that the sample size "is not large enough to split the data into several relevant subgroups. For instance, the number of females is rather small, as is the number of HLA-B27–negative males and females."
Dr. Ramiro said that she had no relevant financial conflicts to disclose.
AT THE ACR ANNUAL MEETING
Major finding: Smokers had a 5.5-fold higher effect of inflammation on x-ray damage, compared with nonsmokers, and male smokers had a 13.4-fold higher effect of inflammation on damage, compared with female nonsmokers.
Data source: An assessment of 127 patients enrolled in the Outcome in AS International Study (OASIS), which followed ankylosing spondylitis patients for up to 12 years with biannual clinical assessments, including radiographs.
Disclosures: Dr. Ramiro said that she had no relevant financial conflicts to disclose.
Antirheumatic drugs don’t boost surgical infection risk
SAN DIEGO – Rheumatoid arthritis patients undergoing surgery who stayed on their antirheumatic medication perioperatively didn’t have a higher risk of early postoperative infection compared with those who temporarily stopped treatment before surgery, according to findings from a large national Veterans Affairs study.
Rheumatologists are frequently consulted about this issue. Evidence to guide practice has been scarce, however, and until now many rheumatologists and surgeons have taken a conservative approach, reasoning that the immunosuppressive drugs employed in controlling inflammation in rheumatoid arthritis might also increase the risk of surgical wound infection.
A common practice has been to have RA patients stop their medication a month ahead of elective surgery, or at least two drug half-lives beforehand, then start treatment again roughly a month after the operation, or when the wound has healed. The new Veterans Affairs (VA) study findings suggest this practice may be unnecessary, Dr. Zaki Abou Zahr said at the annual meeting of the American College of Rheumatology.
Dr. Bernard Ng, his senior coinvestigator in the study, added that temporarily stopping antirheumatic agents before surgery may actually be harmful in that it increases the risk of a flare of the RA, which in turn would impede postoperative rehabilitation.
But there is a major caveat regarding the VA study: Participation was restricted to RA patients on only a single conventional disease-modifying antirheumatic drug (DMARD) or biologic agent leading up to surgery. This restriction, imposed to make for a more clear-cut analysis, means that the study results can’t be extrapolated to patients on multidrug therapy. And multidrug therapy is quite common. Indeed, slightly more than half of RA patients in the VA health care system are on combination therapy, most often methotrexate plus a biologic agent, noted Dr. Ng, chief of rheumatology at the VA Puget Sound Health Care System, Seattle.
Dr. Abou Zahr presented the retrospective cohort study involving 6,548 RA patients in VA administrative databases, all of whom were on antirheumatic drug monotherapy prior to surgery. The surgery was of all types, including cardiothoracic, gastrointestinal, vascular, and orthopedic, as well as emergent and elective.
The primary endpoints were the rate of wound infections, both superficial and deep, within 30 days post surgery, and the general infection rate – including pneumonia, sepsis, and urinary tract infections – during the same time frame.
Sixty-two percent of the 1,480 RA patients on a single biologic agent did not stop taking it preoperatively. One key study finding was that neither their postoperative wound infection rate nor their general infection rate differed significantly from rates in patients who temporarily halted their biologic agent. The same held true among the 70% of patients on a single conventional DMARD who did not stop taking their medication preoperatively, according to Dr. Abou Zahr of Baylor College of Medicine, Houston.
Dr. Ng said the investigators plan to extend their work to include RA patients on multiple antirheumatic drugs that they do or don’t temporarily stop when undergoing surgery within the VA system. The researchers also plan to take a close look at patients undergoing specific types of surgery to see if the postoperative infection risk in patients who remain on treatment varies according to their operation.
Dr. Fehmida Zahabi, a rheumatologist from Plano, Tex., who chaired a press conference highlighting the VA study findings, said that while she’d like to see a confirmatory study, "I think we’re getting to the point where we’re saying we should cautiously keep these patients on their medications. That’s what the data suggest."
She noted that before the VA study, the very limited evidence available to guide practice in this area centered on a 12-year-old British randomized trial involving RA patients on methotrexate undergoing elective orthopedic surgery. Those assigned to stop the drug from 2 weeks before surgery to 2 weeks post surgery had significantly more infections, surgical complications, and RA flares within 6 weeks after surgery (Ann. Rheum. Dis. 2001;60:214-7).
As for patients on multidrug therapy who are scheduled for surgery, her inclination until evidence becomes available for guidance is to pare down the regimen preoperatively, while keeping the patient on one or two drugs.
The VA study was funded by the Department of Veterans Affairs. Dr. Abou Zahr and Dr. Ng reported having no conflicts of interest.
SAN DIEGO – Rheumatoid arthritis patients undergoing surgery who stayed on their antirheumatic medication perioperatively didn’t have a higher risk of early postoperative infection compared with those who temporarily stopped treatment before surgery, according to findings from a large national Veterans Affairs study.
Rheumatologists are frequently consulted about this issue. Evidence to guide practice has been scarce, however, and until now many rheumatologists and surgeons have taken a conservative approach, reasoning that the immunosuppressive drugs employed in controlling inflammation in rheumatoid arthritis might also increase the risk of surgical wound infection.
A common practice has been to have RA patients stop their medication a month ahead of elective surgery, or at least two drug half-lives beforehand, then start treatment again roughly a month after the operation, or when the wound has healed. The new Veterans Affairs (VA) study findings suggest this practice may be unnecessary, Dr. Zaki Abou Zahr said at the annual meeting of the American College of Rheumatology.
Dr. Bernard Ng, his senior coinvestigator in the study, added that temporarily stopping antirheumatic agents before surgery may actually be harmful in that it increases the risk of a flare of the RA, which in turn would impede postoperative rehabilitation.
But there is a major caveat regarding the VA study: Participation was restricted to RA patients on only a single conventional disease-modifying antirheumatic drug (DMARD) or biologic agent leading up to surgery. This restriction, imposed to make for a more clear-cut analysis, means that the study results can’t be extrapolated to patients on multidrug therapy. And multidrug therapy is quite common. Indeed, slightly more than half of RA patients in the VA health care system are on combination therapy, most often methotrexate plus a biologic agent, noted Dr. Ng, chief of rheumatology at the VA Puget Sound Health Care System, Seattle.
Dr. Abou Zahr presented the retrospective cohort study involving 6,548 RA patients in VA administrative databases, all of whom were on antirheumatic drug monotherapy prior to surgery. The surgery was of all types, including cardiothoracic, gastrointestinal, vascular, and orthopedic, as well as emergent and elective.
The primary endpoints were the rate of wound infections, both superficial and deep, within 30 days post surgery, and the general infection rate – including pneumonia, sepsis, and urinary tract infections – during the same time frame.
Sixty-two percent of the 1,480 RA patients on a single biologic agent did not stop taking it preoperatively. One key study finding was that neither their postoperative wound infection rate nor their general infection rate differed significantly from rates in patients who temporarily halted their biologic agent. The same held true among the 70% of patients on a single conventional DMARD who did not stop taking their medication preoperatively, according to Dr. Abou Zahr of Baylor College of Medicine, Houston.
Dr. Ng said the investigators plan to extend their work to include RA patients on multiple antirheumatic drugs that they do or don’t temporarily stop when undergoing surgery within the VA system. The researchers also plan to take a close look at patients undergoing specific types of surgery to see if the postoperative infection risk in patients who remain on treatment varies according to their operation.
Dr. Fehmida Zahabi, a rheumatologist from Plano, Tex., who chaired a press conference highlighting the VA study findings, said that while she’d like to see a confirmatory study, "I think we’re getting to the point where we’re saying we should cautiously keep these patients on their medications. That’s what the data suggest."
She noted that before the VA study, the very limited evidence available to guide practice in this area centered on a 12-year-old British randomized trial involving RA patients on methotrexate undergoing elective orthopedic surgery. Those assigned to stop the drug from 2 weeks before surgery to 2 weeks post surgery had significantly more infections, surgical complications, and RA flares within 6 weeks after surgery (Ann. Rheum. Dis. 2001;60:214-7).
As for patients on multidrug therapy who are scheduled for surgery, her inclination until evidence becomes available for guidance is to pare down the regimen preoperatively, while keeping the patient on one or two drugs.
The VA study was funded by the Department of Veterans Affairs. Dr. Abou Zahr and Dr. Ng reported having no conflicts of interest.
SAN DIEGO – Rheumatoid arthritis patients undergoing surgery who stayed on their antirheumatic medication perioperatively didn’t have a higher risk of early postoperative infection compared with those who temporarily stopped treatment before surgery, according to findings from a large national Veterans Affairs study.
Rheumatologists are frequently consulted about this issue. Evidence to guide practice has been scarce, however, and until now many rheumatologists and surgeons have taken a conservative approach, reasoning that the immunosuppressive drugs employed in controlling inflammation in rheumatoid arthritis might also increase the risk of surgical wound infection.
A common practice has been to have RA patients stop their medication a month ahead of elective surgery, or at least two drug half-lives beforehand, then start treatment again roughly a month after the operation, or when the wound has healed. The new Veterans Affairs (VA) study findings suggest this practice may be unnecessary, Dr. Zaki Abou Zahr said at the annual meeting of the American College of Rheumatology.
Dr. Bernard Ng, his senior coinvestigator in the study, added that temporarily stopping antirheumatic agents before surgery may actually be harmful in that it increases the risk of a flare of the RA, which in turn would impede postoperative rehabilitation.
But there is a major caveat regarding the VA study: Participation was restricted to RA patients on only a single conventional disease-modifying antirheumatic drug (DMARD) or biologic agent leading up to surgery. This restriction, imposed to make for a more clear-cut analysis, means that the study results can’t be extrapolated to patients on multidrug therapy. And multidrug therapy is quite common. Indeed, slightly more than half of RA patients in the VA health care system are on combination therapy, most often methotrexate plus a biologic agent, noted Dr. Ng, chief of rheumatology at the VA Puget Sound Health Care System, Seattle.
Dr. Abou Zahr presented the retrospective cohort study involving 6,548 RA patients in VA administrative databases, all of whom were on antirheumatic drug monotherapy prior to surgery. The surgery was of all types, including cardiothoracic, gastrointestinal, vascular, and orthopedic, as well as emergent and elective.
The primary endpoints were the rate of wound infections, both superficial and deep, within 30 days post surgery, and the general infection rate – including pneumonia, sepsis, and urinary tract infections – during the same time frame.
Sixty-two percent of the 1,480 RA patients on a single biologic agent did not stop taking it preoperatively. One key study finding was that neither their postoperative wound infection rate nor their general infection rate differed significantly from rates in patients who temporarily halted their biologic agent. The same held true among the 70% of patients on a single conventional DMARD who did not stop taking their medication preoperatively, according to Dr. Abou Zahr of Baylor College of Medicine, Houston.
Dr. Ng said the investigators plan to extend their work to include RA patients on multiple antirheumatic drugs that they do or don’t temporarily stop when undergoing surgery within the VA system. The researchers also plan to take a close look at patients undergoing specific types of surgery to see if the postoperative infection risk in patients who remain on treatment varies according to their operation.
Dr. Fehmida Zahabi, a rheumatologist from Plano, Tex., who chaired a press conference highlighting the VA study findings, said that while she’d like to see a confirmatory study, "I think we’re getting to the point where we’re saying we should cautiously keep these patients on their medications. That’s what the data suggest."
She noted that before the VA study, the very limited evidence available to guide practice in this area centered on a 12-year-old British randomized trial involving RA patients on methotrexate undergoing elective orthopedic surgery. Those assigned to stop the drug from 2 weeks before surgery to 2 weeks post surgery had significantly more infections, surgical complications, and RA flares within 6 weeks after surgery (Ann. Rheum. Dis. 2001;60:214-7).
As for patients on multidrug therapy who are scheduled for surgery, her inclination until evidence becomes available for guidance is to pare down the regimen preoperatively, while keeping the patient on one or two drugs.
The VA study was funded by the Department of Veterans Affairs. Dr. Abou Zahr and Dr. Ng reported having no conflicts of interest.
AT THE ACR ANNUAL MEETING
Major finding: Rheumatoid arthritis patients who remained on their antirheumatic medication while they underwent various types of surgery did not have a significantly different 30-day wound infection rate than those who stopped treatment temporarily prior to surgery.
Data source: This was a retrospective observational cohort study involving 6,548 rheumatoid arthritis patients undergoing various types of surgery.
Disclosures: The study was funded by the Department of Veterans Affairs. The presenters reported having no financial conflicts.
Systemic sclerosis brings sharply increased MI risk
SAN DIEGO – Patients with systemic sclerosis are at greater than eightfold increased risk of having an acute myocardial infarction during the first year after diagnosis, compared with matched controls, according to the first large population-based cohort study to look at the issue.
After that first year, the MI risk drops off over time. Still, during years 1-5 post diagnosis the MI risk remains more than triple that of the matched general population, Dr. J. Antonio Avina-Zubieta reported at the annual meeting of the American College of Rheumatology.
"Our findings support increased vigilance in cardiovascular disease prevention, surveillance, and risk modification in patients with systemic sclerosis," declared Dr. Avina-Zubieta, a rheumatologist at the University of British Columbia, Vancouver.
He and his coinvestigators harnessed comprehensive provincial medical databases to identify all 1,245 adults diagnosed with rheumatologist-confirmed systemic sclerosis (SSc) in British Columbia during 1996-2010. The SSc patients averaged 53 years of age at the time of their rheumatologic diagnosis. Eighty-three percent were women.
During a mean follow-up period of 3.5 years following diagnosis of SSc, 89 patients experienced an acute MI, as did 289 controls. This translated to an incidence rate of 20.2 cases per 1,000 person-years among patients with SSc, compared with 5.3 per 1,000 among controls.
The risk was 8.2-fold greater in SSc patients than controls during the first year after diagnosis and 3.5 times greater during years 1-5 after diagnosis, but once patients got more than 5 years out from diagnosis there was no longer any significant increase in MI risk.
Patients with SSc who were in the 45- to 59-year-old age group were at greatest risk: They were 7.4 times more likely than controls to have an MI. SSc patients aged 60-74 years had a 4.4-fold greater risk of MI than did controls, and those aged 75 years and older were at 5.6-fold increased risk.
The SSc patients remained at a 4.3-fold increased risk of MI, compared with controls, in a multivariate analysis extensively adjusted for baseline chronic obstructive pulmonary disease, angina, obesity, hormone replacement therapy, Charlson Comorbidity Index, number of hospitalizations during the 12 months prior to diagnosis, and the use of NSAIDs, COX-2 inhibitors, glucocorticoids, lipid-lowering drugs, and antidiabetic medications.
It is well established that patients with rheumatoid arthritis or systemic lupus erythematosus have an increased risk of premature atherosclerotic disease. Up until now, however, information about the risk of major adverse cardiovascular events in patients with SSc has been scarce and has come from nondefinitive studies in selected populations or cross-sectional studies lacking adequate adjustment for potential confounding factors, according to Dr. Avina-Zubieta, who also is a research scientist at the Arthritis Research Centre of Canada in Richmond, B.C.
Why the sharp increase in MI risk during the first year after diagnosis of SSc? He offered two hypotheses. One is that this is a time of particularly great inflammatory load as physicians work to get the disease under control. Also, there is a phenomenon Dr. Avina-Zubieta called "the depletion of susceptibles," whereby, once the patients at higher risk have had their MI early on, those who remain aren’t at sufficient risk to stand out from the general population.
The study was sponsored by the Arthritis Centre of Canada. Dr. Avina-Zubieta reported having no financial conflicts of interest.
SAN DIEGO – Patients with systemic sclerosis are at greater than eightfold increased risk of having an acute myocardial infarction during the first year after diagnosis, compared with matched controls, according to the first large population-based cohort study to look at the issue.
After that first year, the MI risk drops off over time. Still, during years 1-5 post diagnosis the MI risk remains more than triple that of the matched general population, Dr. J. Antonio Avina-Zubieta reported at the annual meeting of the American College of Rheumatology.
"Our findings support increased vigilance in cardiovascular disease prevention, surveillance, and risk modification in patients with systemic sclerosis," declared Dr. Avina-Zubieta, a rheumatologist at the University of British Columbia, Vancouver.
He and his coinvestigators harnessed comprehensive provincial medical databases to identify all 1,245 adults diagnosed with rheumatologist-confirmed systemic sclerosis (SSc) in British Columbia during 1996-2010. The SSc patients averaged 53 years of age at the time of their rheumatologic diagnosis. Eighty-three percent were women.
During a mean follow-up period of 3.5 years following diagnosis of SSc, 89 patients experienced an acute MI, as did 289 controls. This translated to an incidence rate of 20.2 cases per 1,000 person-years among patients with SSc, compared with 5.3 per 1,000 among controls.
The risk was 8.2-fold greater in SSc patients than controls during the first year after diagnosis and 3.5 times greater during years 1-5 after diagnosis, but once patients got more than 5 years out from diagnosis there was no longer any significant increase in MI risk.
Patients with SSc who were in the 45- to 59-year-old age group were at greatest risk: They were 7.4 times more likely than controls to have an MI. SSc patients aged 60-74 years had a 4.4-fold greater risk of MI than did controls, and those aged 75 years and older were at 5.6-fold increased risk.
The SSc patients remained at a 4.3-fold increased risk of MI, compared with controls, in a multivariate analysis extensively adjusted for baseline chronic obstructive pulmonary disease, angina, obesity, hormone replacement therapy, Charlson Comorbidity Index, number of hospitalizations during the 12 months prior to diagnosis, and the use of NSAIDs, COX-2 inhibitors, glucocorticoids, lipid-lowering drugs, and antidiabetic medications.
It is well established that patients with rheumatoid arthritis or systemic lupus erythematosus have an increased risk of premature atherosclerotic disease. Up until now, however, information about the risk of major adverse cardiovascular events in patients with SSc has been scarce and has come from nondefinitive studies in selected populations or cross-sectional studies lacking adequate adjustment for potential confounding factors, according to Dr. Avina-Zubieta, who also is a research scientist at the Arthritis Research Centre of Canada in Richmond, B.C.
Why the sharp increase in MI risk during the first year after diagnosis of SSc? He offered two hypotheses. One is that this is a time of particularly great inflammatory load as physicians work to get the disease under control. Also, there is a phenomenon Dr. Avina-Zubieta called "the depletion of susceptibles," whereby, once the patients at higher risk have had their MI early on, those who remain aren’t at sufficient risk to stand out from the general population.
The study was sponsored by the Arthritis Centre of Canada. Dr. Avina-Zubieta reported having no financial conflicts of interest.
SAN DIEGO – Patients with systemic sclerosis are at greater than eightfold increased risk of having an acute myocardial infarction during the first year after diagnosis, compared with matched controls, according to the first large population-based cohort study to look at the issue.
After that first year, the MI risk drops off over time. Still, during years 1-5 post diagnosis the MI risk remains more than triple that of the matched general population, Dr. J. Antonio Avina-Zubieta reported at the annual meeting of the American College of Rheumatology.
"Our findings support increased vigilance in cardiovascular disease prevention, surveillance, and risk modification in patients with systemic sclerosis," declared Dr. Avina-Zubieta, a rheumatologist at the University of British Columbia, Vancouver.
He and his coinvestigators harnessed comprehensive provincial medical databases to identify all 1,245 adults diagnosed with rheumatologist-confirmed systemic sclerosis (SSc) in British Columbia during 1996-2010. The SSc patients averaged 53 years of age at the time of their rheumatologic diagnosis. Eighty-three percent were women.
During a mean follow-up period of 3.5 years following diagnosis of SSc, 89 patients experienced an acute MI, as did 289 controls. This translated to an incidence rate of 20.2 cases per 1,000 person-years among patients with SSc, compared with 5.3 per 1,000 among controls.
The risk was 8.2-fold greater in SSc patients than controls during the first year after diagnosis and 3.5 times greater during years 1-5 after diagnosis, but once patients got more than 5 years out from diagnosis there was no longer any significant increase in MI risk.
Patients with SSc who were in the 45- to 59-year-old age group were at greatest risk: They were 7.4 times more likely than controls to have an MI. SSc patients aged 60-74 years had a 4.4-fold greater risk of MI than did controls, and those aged 75 years and older were at 5.6-fold increased risk.
The SSc patients remained at a 4.3-fold increased risk of MI, compared with controls, in a multivariate analysis extensively adjusted for baseline chronic obstructive pulmonary disease, angina, obesity, hormone replacement therapy, Charlson Comorbidity Index, number of hospitalizations during the 12 months prior to diagnosis, and the use of NSAIDs, COX-2 inhibitors, glucocorticoids, lipid-lowering drugs, and antidiabetic medications.
It is well established that patients with rheumatoid arthritis or systemic lupus erythematosus have an increased risk of premature atherosclerotic disease. Up until now, however, information about the risk of major adverse cardiovascular events in patients with SSc has been scarce and has come from nondefinitive studies in selected populations or cross-sectional studies lacking adequate adjustment for potential confounding factors, according to Dr. Avina-Zubieta, who also is a research scientist at the Arthritis Research Centre of Canada in Richmond, B.C.
Why the sharp increase in MI risk during the first year after diagnosis of SSc? He offered two hypotheses. One is that this is a time of particularly great inflammatory load as physicians work to get the disease under control. Also, there is a phenomenon Dr. Avina-Zubieta called "the depletion of susceptibles," whereby, once the patients at higher risk have had their MI early on, those who remain aren’t at sufficient risk to stand out from the general population.
The study was sponsored by the Arthritis Centre of Canada. Dr. Avina-Zubieta reported having no financial conflicts of interest.
AT THE ACR ANNUAL MEETING
Major finding: The incidence rate of acute MI following diagnosis of systemic sclerosis was 20.2 events per 1,000 person-years, compared with 5.3 per 1,000 in matched controls.
Data source: Population-based cohort study included all 1,245 adults diagnosed with systemic sclerosis in British Columbia in 1990-2010 and 12,678 matched controls drawn from the general population.
Disclosures: The study was sponsored by the Arthritis Centre of Canada. Dr. Avina-Zubieta reported having no financial conflicts of interest.
Treatment adherence poor among Medicaid beneficiaries with lupus
SAN DIEGO – Fewer than one in three Medicaid beneficiaries with systemic lupus erythematosus are adhering to their recommended treatment regimens at least 80% of the time, results from a large national analysis demonstrated.
"As a physician who spends my professional time taking care of people with lupus, these data are highly concerning," Dr. Jinoos Yazdany said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented. "For many individuals with lupus, treatment is very effective and has a proven track record of preventing life-threatening complications and long-term organ damage such as kidney failure. The fact that less than one in three patients are adhering with treatment is alarming and should serve as a call to action for those of providing care to these patients."
Dr. Yazdany, associate director of the lupus clinic at the University of California-San Francisco Medical Center, and her colleagues used MAX (Medicaid Analytic eXtract) data from 2000 to 2006 to identify 23,187 patients with systemic lupus erythematosus (SLE) who were taking at least one immunosuppressive or antimalarial drug. They used pharmacy claims to assess adherence to drugs over a period of 180 days by calculating a medication possession ratio (MPR), defined as the proportion of days covered by the total days’ supply dispensed after the first claim for each drug. The researchers also evaluated the proportion of patients who had an MPR of 80% or greater. The oral drugs studied were hydroxychloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, and leflunomide.
The mean age of the 23,187 patients was 38 years, 94% were female, and the racial and ethnic makeup was diverse (40% black, 34% white, 16% Hispanic, 5% Asian, and 5% other). The highest proportion of SLE patients lived in the southern United States (36%).
Dr. Yazdany reported that the average MPR ranged from 31.1% for tacrolimus to 56% for hydroxychloroquine. In addition, for most drugs, fewer than one in three patients had an MPR of at least 80%. Overall adherence was poorest among those taking tacrolimus (14%) and highest among those taking mycophenolate mofetil (40%).
Across all medications, blacks had lower adherence, compared with whites, and adherence was highest for those residing in the Northeast.
"Our findings underscore the need to understand the reasons behind low adherence in this high-risk and vulnerable group of patients," Dr. Yazdany said. "And we urgently need to develop interventions to improve adherence. Physicians may be unaware of their patient’s adherence with medication, and patients may not be forthcoming about this issue. Concerns about side effects, inadequate understanding of the benefit, and the medication’s cost may be barriers for patients. Treatment-associated side effects may be another important barrier. We need better patient-physician communication around the issue of adherence."
The Medicaid administrative data allowed for an otherwise unobtainable nationwide view of adherence in SLE, but Dr. Yazdany acknowledged certain limitations of the study, including the fact that treatment "may be interrupted for clinically appropriate reasons, so the medication possession ratios in our study may underestimate actual adherence. Also, pharmacy claims are imperfect proxies for whether patients actually take medications that are dispensed, which might lead to an overestimation of adherence."
Dr. Yazdany disclosed that her research is funded by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. She had no other relevant financial conflicts to disclose.
SAN DIEGO – Fewer than one in three Medicaid beneficiaries with systemic lupus erythematosus are adhering to their recommended treatment regimens at least 80% of the time, results from a large national analysis demonstrated.
"As a physician who spends my professional time taking care of people with lupus, these data are highly concerning," Dr. Jinoos Yazdany said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented. "For many individuals with lupus, treatment is very effective and has a proven track record of preventing life-threatening complications and long-term organ damage such as kidney failure. The fact that less than one in three patients are adhering with treatment is alarming and should serve as a call to action for those of providing care to these patients."
Dr. Yazdany, associate director of the lupus clinic at the University of California-San Francisco Medical Center, and her colleagues used MAX (Medicaid Analytic eXtract) data from 2000 to 2006 to identify 23,187 patients with systemic lupus erythematosus (SLE) who were taking at least one immunosuppressive or antimalarial drug. They used pharmacy claims to assess adherence to drugs over a period of 180 days by calculating a medication possession ratio (MPR), defined as the proportion of days covered by the total days’ supply dispensed after the first claim for each drug. The researchers also evaluated the proportion of patients who had an MPR of 80% or greater. The oral drugs studied were hydroxychloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, and leflunomide.
The mean age of the 23,187 patients was 38 years, 94% were female, and the racial and ethnic makeup was diverse (40% black, 34% white, 16% Hispanic, 5% Asian, and 5% other). The highest proportion of SLE patients lived in the southern United States (36%).
Dr. Yazdany reported that the average MPR ranged from 31.1% for tacrolimus to 56% for hydroxychloroquine. In addition, for most drugs, fewer than one in three patients had an MPR of at least 80%. Overall adherence was poorest among those taking tacrolimus (14%) and highest among those taking mycophenolate mofetil (40%).
Across all medications, blacks had lower adherence, compared with whites, and adherence was highest for those residing in the Northeast.
"Our findings underscore the need to understand the reasons behind low adherence in this high-risk and vulnerable group of patients," Dr. Yazdany said. "And we urgently need to develop interventions to improve adherence. Physicians may be unaware of their patient’s adherence with medication, and patients may not be forthcoming about this issue. Concerns about side effects, inadequate understanding of the benefit, and the medication’s cost may be barriers for patients. Treatment-associated side effects may be another important barrier. We need better patient-physician communication around the issue of adherence."
The Medicaid administrative data allowed for an otherwise unobtainable nationwide view of adherence in SLE, but Dr. Yazdany acknowledged certain limitations of the study, including the fact that treatment "may be interrupted for clinically appropriate reasons, so the medication possession ratios in our study may underestimate actual adherence. Also, pharmacy claims are imperfect proxies for whether patients actually take medications that are dispensed, which might lead to an overestimation of adherence."
Dr. Yazdany disclosed that her research is funded by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. She had no other relevant financial conflicts to disclose.
SAN DIEGO – Fewer than one in three Medicaid beneficiaries with systemic lupus erythematosus are adhering to their recommended treatment regimens at least 80% of the time, results from a large national analysis demonstrated.
"As a physician who spends my professional time taking care of people with lupus, these data are highly concerning," Dr. Jinoos Yazdany said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented. "For many individuals with lupus, treatment is very effective and has a proven track record of preventing life-threatening complications and long-term organ damage such as kidney failure. The fact that less than one in three patients are adhering with treatment is alarming and should serve as a call to action for those of providing care to these patients."
Dr. Yazdany, associate director of the lupus clinic at the University of California-San Francisco Medical Center, and her colleagues used MAX (Medicaid Analytic eXtract) data from 2000 to 2006 to identify 23,187 patients with systemic lupus erythematosus (SLE) who were taking at least one immunosuppressive or antimalarial drug. They used pharmacy claims to assess adherence to drugs over a period of 180 days by calculating a medication possession ratio (MPR), defined as the proportion of days covered by the total days’ supply dispensed after the first claim for each drug. The researchers also evaluated the proportion of patients who had an MPR of 80% or greater. The oral drugs studied were hydroxychloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, and leflunomide.
The mean age of the 23,187 patients was 38 years, 94% were female, and the racial and ethnic makeup was diverse (40% black, 34% white, 16% Hispanic, 5% Asian, and 5% other). The highest proportion of SLE patients lived in the southern United States (36%).
Dr. Yazdany reported that the average MPR ranged from 31.1% for tacrolimus to 56% for hydroxychloroquine. In addition, for most drugs, fewer than one in three patients had an MPR of at least 80%. Overall adherence was poorest among those taking tacrolimus (14%) and highest among those taking mycophenolate mofetil (40%).
Across all medications, blacks had lower adherence, compared with whites, and adherence was highest for those residing in the Northeast.
"Our findings underscore the need to understand the reasons behind low adherence in this high-risk and vulnerable group of patients," Dr. Yazdany said. "And we urgently need to develop interventions to improve adherence. Physicians may be unaware of their patient’s adherence with medication, and patients may not be forthcoming about this issue. Concerns about side effects, inadequate understanding of the benefit, and the medication’s cost may be barriers for patients. Treatment-associated side effects may be another important barrier. We need better patient-physician communication around the issue of adherence."
The Medicaid administrative data allowed for an otherwise unobtainable nationwide view of adherence in SLE, but Dr. Yazdany acknowledged certain limitations of the study, including the fact that treatment "may be interrupted for clinically appropriate reasons, so the medication possession ratios in our study may underestimate actual adherence. Also, pharmacy claims are imperfect proxies for whether patients actually take medications that are dispensed, which might lead to an overestimation of adherence."
Dr. Yazdany disclosed that her research is funded by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. She had no other relevant financial conflicts to disclose.
AT THE ACR ANNUAL MEETING
Major finding: Among Medicaid beneficiaries with SLE, the average medication possession ratio ranged from 31.1% for tacrolimus to 56% for hydroxychloroquine.
Data source: A study of 23,187 Medicaid patients with SLE who were taking at least one immunosuppressive or antimalarial drug between 2000 and 2006.
Disclosures: Dr. Yazdany disclosed that her research is funded by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. She had no other relevant financial conflicts to disclose.
HPV Vaccine Uptake Low in Autoimmune Disease Patients
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
persistent HPV infection, immunosuppressive drugs,
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
persistent HPV infection, immunosuppressive drugs,
persistent HPV infection, immunosuppressive drugs,
AT THE ACR ANNUAL MEETING
HPV vaccine uptake low in autoimmune disease patients
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
persistent HPV infection, immunosuppressive drugs,
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
SAN DIEGO – Only 8.5% of children and young adults with autoimmune diseases and 9.1% of those without such diseases received one or more doses of the human papillomavirus vaccine, a large analysis of national claims data showed.
"Despite the high efficacy of HPV vaccine in preventing cervical cancer and clinically acceptable safety profile in the general population, the vast majority of patients aged 9-26 in our study cohort with and without autoimmune diseases did not receive the HPV vaccine," Dr. Seoyoung C. Kim said in an interview prior to the annual meeting of the American College of Rheumatology, where the study was presented.
"Patients at high risk of persistent HPV infection should be encouraged to receive the vaccine, although future study is needed to determine the effectiveness of HPV vaccine in patients with autoimmune diseases, particularly those on immunosuppressive drugs," she added.
In 2006 and 2009, two three-dose series HPV vaccines were approved for use in males and females aged 9-26 years. Prior research has suggested that patients with lupus or inflammatory bowel disease or those who take immunosuppressive agents have a higher risk of persistent HPV infection or cervical dysplasia, said Dr. Kim of the division of pharmacoepidemiology and pharmacoeconomics in the department of medicine at Brigham and Women’s Hospital, Boston.
"HPV vaccine has been available for the past several years in the U.S. and in other countries," she said. "As far as we know, there has not been any study looking at the uptake of HPV vaccine in the autoimmune disease population."
Using United HealthCare national claims data for 2005-2012, Dr. Kim and her associates identified patients aged 9-26 years with at least 1 year of continuous enrollment who had at least two autoimmune disease diagnosis codes 7 or more days apart. Vaccination was defined as one or more vaccine codes after 2006, and the researchers accounted for coexisting diseases, use of health care treatments, and geographic regions when assessing vaccine uptake.
Dr. Kim, the study’s senior investigator, reported data for 29,255 children and young adults with autoimmune diseases and 117,020 without. The mean age was 19 years, and 59% were female. Patients in the autoimmune diseases group had a higher number of physician visits, abnormal pap smears, and sexually transmitted diseases, compared with their counterparts without autoimmune disease (all P values less than .01).
Overall, autoimmune disease patients and their counterparts had similarly low uptake of at least one vaccine dose (8.5% vs. 9.1%, respectively; P = .34). The uptake was higher among females in both groups (13.1% vs. 14.1%, respectively; P less than .01), yet fewer than 5% of female patients in both groups completed a three-dose vaccine series (4.7% vs. 4.6%; P = .57). A higher percentage of patients in the Northeast received one or more HPV vaccine doses (16.3% vs. 11.8%; P = .02); otherwise vaccinations were equally distributed from a geographic standpoint.
In a subgroup of female patients who had at least 2 years of follow-up, 20.6% with autoimmune disease and 23.1% without autoimmune disease received at least one vaccine dose. Of those, 53.1% and 51.4%, respectively, completed the series.
"We were generally surprised to see how low the uptake has been in both autoimmune and nonautoimmune populations," Dr. Kim said. She acknowledged certain limitations of the study, including the fact that it was conducting using the claims data from United HealthCare, "so it only captures patients who used the insurance card to pay for the vaccine," she said. "However, given the high cost of the HPV vaccine, this limitation is probably not substantial. We [also] did not have information on race/ethnicity."
Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
persistent HPV infection, immunosuppressive drugs,
persistent HPV infection, immunosuppressive drugs,
AT THE ACR ANNUAL MEETING
Major finding: Children and young adults with autoimmune diseases and their counterparts with no such diseases had similarly low uptake of at least one dose of human papillomavirus vaccine (8.5% vs. 9.1%, respectively; P = .34).
Data source: An analysis of national claims data for 29,255 children and young adults with autoimmune diseases and 117,020 without such diseases.
Disclosures: Dr. Kim disclosed that she is supported by a grant from the National Institutes of Health. She received a research grant from Pfizer and tuition support for the pharmacoepidemiology program at the Harvard School of Public Health, which is funded by Pfizer, Millennium Pharma, and Asisa.
