AAN Annual Meeting

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – The only factor associated with readmission within 30 days among patients with stroke or cerebrovascular disease was an index hospitalization that lasted more than 10 days, results from a large, single-center analysis found.

"One proposed mechanism to reduce 30-day readmissions has been early post-discharge outpatient follow-up," researchers led by Dr. Fadi Nahab wrote in a poster presented at the annual meeting of the American Academy of Neurology. "In our study population, only 5% of patients had an outpatient follow-up recommended within 1 week. Scheduling follow-up [within 1 week] in a specialty stroke clinic prior to discharge should be evaluated as a potential approach to reduce 30-day readmissions among patients discharged with a diagnosis of stroke or cerebrovascular disease."

Dr. Nahab of the department of neurology at Emory University, Atlanta, and his associates used University HealthSystem Consortium records to identify 2,706 patients discharged from Emory University Hospital with a diagnosis of stroke or cerebrovascular disease between Jan. 1, 2007, and Dec. 31, 2009. They excluded patients readmitted within 30 days for rehabilitation, chemotherapy, radiation therapy, dialysis, and delivery.

The study population included patients with a mean age of 62 years and most were white (55%) or black (33%). Their diagnoses at discharge were ischemic stroke (35%), subarachnoid hemorrhage (25%), intracerebral hemorrhage (16%), transient ischemic attack (7%), or other cerebrovascular diseases (17%).

Of the 2,706 patients studied, 174 had 178 readmissions within 30 days, for a rate of 7%. The top three discharging providers were neurologists (40%), neurosurgeons (33%), and vascular surgeons (16%).

Multivariate analysis revealed that an index hospital stay of more than 10 days was the only significant factor associated with readmission within 30 days (odds ratio of 2.34 when compared with an index hospital stay of less than 5 days). Age, gender, race, primary diagnosis, the specialty of the discharging clinicians, and the year of discharge were not significant predictors.

"Length of stay is often considered a representation of disease severity and our results add support to the previously mixed data showing that a prolonged hospital length of stay is associated with higher readmission rates among patients with stroke and cerebrovascular disease," Dr. Nahab said in an interview after the meeting.

Among nonsurgical specialties, the researchers observed a trend toward lower 30-day readmission rates by neurologists than by physicians from other specialties: 6% among neurologists, compared with 9% among internists and cardiologists.

The researchers also found that initial follow-up was recommended within 30 days for 57% of patients and within one week for 5% of patients. However, only 14% of patients had an outpatient follow-up appointment scheduled prior to discharge. In the study, a lack of early outpatient follow-up represented the most common contributor to unplanned avoidable readmissions.

"While identifying patient characteristics that predict the likelihood of a readmission may help providers recognize patients who are at greatest risk for readmission, the significant heterogeneity among prior studies highlights the complexity of factors that contribute to readmission among stroke patients," Dr. Nahab said. "If we are to intervene and reduce readmissions, early (less than 1 week) outpatient follow-up scheduled prior to hospital discharge needs to be studied as one possible answer."

Dr. Nahab said that he had no relevant financial disclosures to make.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Oral therapies for relapsing-remitting multiple sclerosis that are in the development pipeline have neurologists feeling both excited and a bit apprehensive.

"There are a whole slew of orals coming," Dr. Mariko Kita said in an interview at the annual meeting of the American Academy of Neurology. "It’s really exciting, but I think it will be challenging for the clinician" because there will be inadequate guidance on which drug or drugs to prioritize in treatment, how best to combine various therapies, and other clinical questions.

"I think it’s going to be very intimidating, actually," said Dr. Kita, director of the Multiple Sclerosis Center at Virginia Mason Medical Center, Seattle.

She comoderated a session at the meeting on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

Another oral agent under study, BG-12 (dimethyl fumarate), received Fast Track designation from the Food and Drug Administration and is in phase III clinical trials. Cladribine (Leustatin), which is currently marketed as chemotherapy for certain leukemias and lymphomas, initially was rejected by the FDA when it was submitted for approval as an oral therapy for multiple sclerosis. Following resubmission by the manufacturer, the FDA in early 2011 sent a letter to the company acknowledging sufficient data on the drug’s efficacy in multiple sclerosis but requiring more data on safety and risk-benefit considerations before it could be approved.

Dr. Kita’s comoderator, Dr. Benjamin N. Greenberg, commented after the session that with the expected approvals of several oral agents for multiple sclerosis over the next few years, "I’m getting concerned that there’s going to be a little bit of a free-for-all coming." But he added, "It’s good to have options. We’re all thrilled."

The only head-to-head comparison of an oral therapy against another active treatment for multiple sclerosis so far is a study of fingolimod vs. interferon, he noted. Direct comparisons of the various oral agents will be needed to help clinicians develop treatment strategies, said Dr. Greenberg, a neurologist at the University of Texas Southwestern Medical Center, Dallas.

Gilenya may have some superior efficacy, compared with once-weekly interferon dosing, Dr. Kita said, but its potential adverse cardiovascular effects and "downstream consequences in terms of effects on different organ systems makes another oral daily alternative with less toxicity that much more appealing."

Dr. Aaron Miller of Mount Sinai School of Medicine, New York, and Dr. Jerry S. Wolinsky of the University of Texas Health Science Center, Houston, presented results of the Teriflunomide Multiple Sclerosis Oral (TEMSO) trial during the session. The multinational, double-blind study randomized 1,088 patients with relapsing-remitting multiple sclerosis to a single daily dose of 7 mg or 14 mg of teriflunomide or placebo for 2 years.

Results of the TEMSO trial were first reported in late 2010.

Both doses reduced the annualized relapse rate by approximately 31%, compared with placebo. The annualized relapse rate was 0.37 in each of the treatment groups and 0.54 in the placebo group. The risk of disability progression also was significantly reduced by 30% in the 14-mg group but was not significantly different in the 7-mg group, compared with placebo.

Both doses showed significant improvements, compared with placebo, in brain disease activity on various MRI tests, although some MRI measures of disease activity were significantly better only in the high-dose group, compared with placebo.

Results of the 2-year, randomized, double-blind study of laquinimod that was presented earlier at the meeting showed an annual relapse rate of 0.304 on laquinimod, a 23% reduction compared with a rate of 0.395 on placebo. The laquinimod group also showed 33% less brain atrophy and significant improvements in brain disease activity on various MRI measures.

Both teriflunomide and laquinimod appeared to be relatively well tolerated. But among 11 women who became pregnant in the TEMSO study, 3 of 4 spontaneous abortions occurred in the teriflunomide groups. Six of the other pregnant women underwent induced abortions, and one woman successfully delivered a healthy baby.

"I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points," Dr. Kita said. "My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years. We know that its parent compound can have teratogenic effects, and I’m not sure we know yet how safe teriflunomide will be in the population."

Dr. Kita said she has no relevant conflicts of interest. Dr. Greenberg disclosed financial relationships with DioGenix, Biogen Idec (which is developing BG-12), EMD Serono (which is developing cladribine), Teva Neurosciences (which is developing laquinimod), and the Greater Good Foundation.

Sanofi-Aventis, which is developing teriflunomide, funded the TEMSO trial. Dr. Miller, Dr. Wolinsky, and many of their associates in the study disclosed relationships with Sanofi-Aventis and with numerous other companies that make therapies for multiple sclerosis. Three of their co-investigators were employees of Sanofi-Aventis.

HONOLULU – Oral therapies for relapsing-remitting multiple sclerosis that are in the development pipeline have neurologists feeling both excited and a bit apprehensive.

"There are a whole slew of orals coming," Dr. Mariko Kita said in an interview at the annual meeting of the American Academy of Neurology. "It’s really exciting, but I think it will be challenging for the clinician" because there will be inadequate guidance on which drug or drugs to prioritize in treatment, how best to combine various therapies, and other clinical questions.

"I think it’s going to be very intimidating, actually," said Dr. Kita, director of the Multiple Sclerosis Center at Virginia Mason Medical Center, Seattle.

She comoderated a session at the meeting on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

Another oral agent under study, BG-12 (dimethyl fumarate), received Fast Track designation from the Food and Drug Administration and is in phase III clinical trials. Cladribine (Leustatin), which is currently marketed as chemotherapy for certain leukemias and lymphomas, initially was rejected by the FDA when it was submitted for approval as an oral therapy for multiple sclerosis. Following resubmission by the manufacturer, the FDA in early 2011 sent a letter to the company acknowledging sufficient data on the drug’s efficacy in multiple sclerosis but requiring more data on safety and risk-benefit considerations before it could be approved.

Dr. Kita’s comoderator, Dr. Benjamin N. Greenberg, commented after the session that with the expected approvals of several oral agents for multiple sclerosis over the next few years, "I’m getting concerned that there’s going to be a little bit of a free-for-all coming." But he added, "It’s good to have options. We’re all thrilled."

The only head-to-head comparison of an oral therapy against another active treatment for multiple sclerosis so far is a study of fingolimod vs. interferon, he noted. Direct comparisons of the various oral agents will be needed to help clinicians develop treatment strategies, said Dr. Greenberg, a neurologist at the University of Texas Southwestern Medical Center, Dallas.

Gilenya may have some superior efficacy, compared with once-weekly interferon dosing, Dr. Kita said, but its potential adverse cardiovascular effects and "downstream consequences in terms of effects on different organ systems makes another oral daily alternative with less toxicity that much more appealing."

Dr. Aaron Miller of Mount Sinai School of Medicine, New York, and Dr. Jerry S. Wolinsky of the University of Texas Health Science Center, Houston, presented results of the Teriflunomide Multiple Sclerosis Oral (TEMSO) trial during the session. The multinational, double-blind study randomized 1,088 patients with relapsing-remitting multiple sclerosis to a single daily dose of 7 mg or 14 mg of teriflunomide or placebo for 2 years.

Results of the TEMSO trial were first reported in late 2010.

Both doses reduced the annualized relapse rate by approximately 31%, compared with placebo. The annualized relapse rate was 0.37 in each of the treatment groups and 0.54 in the placebo group. The risk of disability progression also was significantly reduced by 30% in the 14-mg group but was not significantly different in the 7-mg group, compared with placebo.

Both doses showed significant improvements, compared with placebo, in brain disease activity on various MRI tests, although some MRI measures of disease activity were significantly better only in the high-dose group, compared with placebo.

Results of the 2-year, randomized, double-blind study of laquinimod that was presented earlier at the meeting showed an annual relapse rate of 0.304 on laquinimod, a 23% reduction compared with a rate of 0.395 on placebo. The laquinimod group also showed 33% less brain atrophy and significant improvements in brain disease activity on various MRI measures.

Both teriflunomide and laquinimod appeared to be relatively well tolerated. But among 11 women who became pregnant in the TEMSO study, 3 of 4 spontaneous abortions occurred in the teriflunomide groups. Six of the other pregnant women underwent induced abortions, and one woman successfully delivered a healthy baby.

"I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points," Dr. Kita said. "My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years. We know that its parent compound can have teratogenic effects, and I’m not sure we know yet how safe teriflunomide will be in the population."

Dr. Kita said she has no relevant conflicts of interest. Dr. Greenberg disclosed financial relationships with DioGenix, Biogen Idec (which is developing BG-12), EMD Serono (which is developing cladribine), Teva Neurosciences (which is developing laquinimod), and the Greater Good Foundation.

Sanofi-Aventis, which is developing teriflunomide, funded the TEMSO trial. Dr. Miller, Dr. Wolinsky, and many of their associates in the study disclosed relationships with Sanofi-Aventis and with numerous other companies that make therapies for multiple sclerosis. Three of their co-investigators were employees of Sanofi-Aventis.

HONOLULU – Oral therapies for relapsing-remitting multiple sclerosis that are in the development pipeline have neurologists feeling both excited and a bit apprehensive.

"There are a whole slew of orals coming," Dr. Mariko Kita said in an interview at the annual meeting of the American Academy of Neurology. "It’s really exciting, but I think it will be challenging for the clinician" because there will be inadequate guidance on which drug or drugs to prioritize in treatment, how best to combine various therapies, and other clinical questions.

"I think it’s going to be very intimidating, actually," said Dr. Kita, director of the Multiple Sclerosis Center at Virginia Mason Medical Center, Seattle.

She comoderated a session at the meeting on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

Another oral agent under study, BG-12 (dimethyl fumarate), received Fast Track designation from the Food and Drug Administration and is in phase III clinical trials. Cladribine (Leustatin), which is currently marketed as chemotherapy for certain leukemias and lymphomas, initially was rejected by the FDA when it was submitted for approval as an oral therapy for multiple sclerosis. Following resubmission by the manufacturer, the FDA in early 2011 sent a letter to the company acknowledging sufficient data on the drug’s efficacy in multiple sclerosis but requiring more data on safety and risk-benefit considerations before it could be approved.

Dr. Kita’s comoderator, Dr. Benjamin N. Greenberg, commented after the session that with the expected approvals of several oral agents for multiple sclerosis over the next few years, "I’m getting concerned that there’s going to be a little bit of a free-for-all coming." But he added, "It’s good to have options. We’re all thrilled."

The only head-to-head comparison of an oral therapy against another active treatment for multiple sclerosis so far is a study of fingolimod vs. interferon, he noted. Direct comparisons of the various oral agents will be needed to help clinicians develop treatment strategies, said Dr. Greenberg, a neurologist at the University of Texas Southwestern Medical Center, Dallas.

Gilenya may have some superior efficacy, compared with once-weekly interferon dosing, Dr. Kita said, but its potential adverse cardiovascular effects and "downstream consequences in terms of effects on different organ systems makes another oral daily alternative with less toxicity that much more appealing."

Dr. Aaron Miller of Mount Sinai School of Medicine, New York, and Dr. Jerry S. Wolinsky of the University of Texas Health Science Center, Houston, presented results of the Teriflunomide Multiple Sclerosis Oral (TEMSO) trial during the session. The multinational, double-blind study randomized 1,088 patients with relapsing-remitting multiple sclerosis to a single daily dose of 7 mg or 14 mg of teriflunomide or placebo for 2 years.

Results of the TEMSO trial were first reported in late 2010.

Both doses reduced the annualized relapse rate by approximately 31%, compared with placebo. The annualized relapse rate was 0.37 in each of the treatment groups and 0.54 in the placebo group. The risk of disability progression also was significantly reduced by 30% in the 14-mg group but was not significantly different in the 7-mg group, compared with placebo.

Both doses showed significant improvements, compared with placebo, in brain disease activity on various MRI tests, although some MRI measures of disease activity were significantly better only in the high-dose group, compared with placebo.

Results of the 2-year, randomized, double-blind study of laquinimod that was presented earlier at the meeting showed an annual relapse rate of 0.304 on laquinimod, a 23% reduction compared with a rate of 0.395 on placebo. The laquinimod group also showed 33% less brain atrophy and significant improvements in brain disease activity on various MRI measures.

Both teriflunomide and laquinimod appeared to be relatively well tolerated. But among 11 women who became pregnant in the TEMSO study, 3 of 4 spontaneous abortions occurred in the teriflunomide groups. Six of the other pregnant women underwent induced abortions, and one woman successfully delivered a healthy baby.

"I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points," Dr. Kita said. "My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years. We know that its parent compound can have teratogenic effects, and I’m not sure we know yet how safe teriflunomide will be in the population."

Dr. Kita said she has no relevant conflicts of interest. Dr. Greenberg disclosed financial relationships with DioGenix, Biogen Idec (which is developing BG-12), EMD Serono (which is developing cladribine), Teva Neurosciences (which is developing laquinimod), and the Greater Good Foundation.

Sanofi-Aventis, which is developing teriflunomide, funded the TEMSO trial. Dr. Miller, Dr. Wolinsky, and many of their associates in the study disclosed relationships with Sanofi-Aventis and with numerous other companies that make therapies for multiple sclerosis. Three of their co-investigators were employees of Sanofi-Aventis.