Heidi Splete

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews

Major Finding: In this sample, 47% of children with allergies also were deficient in vitamin D.

Data Source: Researchers assess vitamin D levels in 99 children who had asthma, atopic dermatitis, and/or a food allergy.

Disclosures: Researchers had no financial conflicts to disclosure. The study was supported in part by a grant from the National Institutes of Health.

NEW ORLEANS — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger.

Previous published studies in the literature have suggested that vitamin D insufficiency contributes to the pathophysiology of allergic disease.

However, data on vitamin D's impact on children with allergies and asthma are limited, Dr. Daniel Searing said in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In his investigation, Dr. Searing and colleagues at National Jewish Health in Denver, Colo., identified 99 children who had asthma, atopic dermatitis, and/or a food allergy.

The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing.

Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10).

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers explained.

In turn, the addition of supplemental vitamin D can enhance the activity of dexa-methasone more than 10-fold, they added.

However, “the relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized.

But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL), and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively).

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

To watch an interview of Dr. Searing, go to www.youtube.com/user/ElsGlobalMedicalNews

Major Finding: In this sample, 47% of children with allergies also were deficient in vitamin D.

Data Source: Researchers assess vitamin D levels in 99 children who had asthma, atopic dermatitis, and/or a food allergy.

Disclosures: Researchers had no financial conflicts to disclosure. The study was supported in part by a grant from the National Institutes of Health.

NEW ORLEANS — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger.

Previous published studies in the literature have suggested that vitamin D insufficiency contributes to the pathophysiology of allergic disease.

However, data on vitamin D's impact on children with allergies and asthma are limited, Dr. Daniel Searing said in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In his investigation, Dr. Searing and colleagues at National Jewish Health in Denver, Colo., identified 99 children who had asthma, atopic dermatitis, and/or a food allergy.

The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing.

Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10).

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers explained.

In turn, the addition of supplemental vitamin D can enhance the activity of dexa-methasone more than 10-fold, they added.

However, “the relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized.

But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL), and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively).

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

To watch an interview of Dr. Searing, go to www.youtube.com/user/ElsGlobalMedicalNews

Major Finding: In this sample, 47% of children with allergies also were deficient in vitamin D.

Data Source: Researchers assess vitamin D levels in 99 children who had asthma, atopic dermatitis, and/or a food allergy.

Disclosures: Researchers had no financial conflicts to disclosure. The study was supported in part by a grant from the National Institutes of Health.

NEW ORLEANS — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger.

Previous published studies in the literature have suggested that vitamin D insufficiency contributes to the pathophysiology of allergic disease.

However, data on vitamin D's impact on children with allergies and asthma are limited, Dr. Daniel Searing said in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In his investigation, Dr. Searing and colleagues at National Jewish Health in Denver, Colo., identified 99 children who had asthma, atopic dermatitis, and/or a food allergy.

The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing.

Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10).

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers explained.

In turn, the addition of supplemental vitamin D can enhance the activity of dexa-methasone more than 10-fold, they added.

However, “the relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized.

But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL), and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively).

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

To watch an interview of Dr. Searing, go to www.youtube.com/user/ElsGlobalMedicalNews

NEW ORLEANS – Children's school absences and their parents' absences from work represented the greatest economic burden of impairment in children with severe asthma, according to data from an observational study of more than 600 children.

“Asthma costs in the United States have exceeded $10 billion,” said Dr. Stanley J. Szefler of National Jewish Health in Denver, and his colleagues at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. That figure includes $4.6 billion in indirect costs, such as mortality and lost school and work days, and $6.1 billion in direct costs, such as medications and hospital stays.

Dr. Szefler and his colleagues examined whether improvements in asthma impairment in young children reduced the cost burden of asthma. The study was the first to assess the economic burden of asthma in children aged 6-12 years with severe or difficult-to-treat illness as defined by the National Heart, Lung, and Blood Institute's guidelines, the researchers said.

The study included 628 children aged 6 years and older with severe or refractory asthma. At baseline, 386 children had very poorly controlled (VPC) asthma, 219 had not well-controlled (NWC) asthma, and 23 had well-controlled (WC) asthma. The children were a subgroup of the TENOR study, a large, observational study that assessed patients with severe and difficult-to-treat asthma. A total of 62% of the children were classified as VPC, the researchers noted.

The researchers compared the cumulative costs for patients who were consistently VPC at baseline, 12 months, and 24 months with the costs for patients who improved over the 24-month study period. Primary outcomes included school days lost, cost of asthma medications, unscheduled doctor visits, overnight hospital stays, and emergency department visits.

Overall, the cost of school and work days lost in the VPC group at baseline, 12 months, and 24 months was $3,087, $3,139, and $4,277, respectively. Those costs were significantly higher than for the NWC group ($369, $251, and $478, respectively) and the WC group ($0, $166, $0, respectively). The costs of school absences were measured using gender-specific dollar amounts to represent a parent's lost work day and adjusted to 2002 dollars.

The costs of medications were the next largest contributor to cost burden. Medication costs in the VPC group at baseline ($2,117), 12 months ($2,312), and 24 months ($2,298) were significantly higher than in the NWC group ($1,949, $1,987, and $1,995, respectively) and the WC group ($1,861, $1,640, and $1,605). The costs of medications were measured using the average recommended daily dose.

“The highest costs were associated with patients whose asthma impairment status remained consistently VPC,” the researchers wrote.

The study was sponsored by Genentech Inc. Dr. Szefler received funding from several organizations that are sponsored by the National Institutes of Health, as well as from several pharmaceutical companies.

Source Elsevier Global Medical News

NEW ORLEANS – Children's school absences and their parents' absences from work represented the greatest economic burden of impairment in children with severe asthma, according to data from an observational study of more than 600 children.

“Asthma costs in the United States have exceeded $10 billion,” said Dr. Stanley J. Szefler of National Jewish Health in Denver, and his colleagues at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. That figure includes $4.6 billion in indirect costs, such as mortality and lost school and work days, and $6.1 billion in direct costs, such as medications and hospital stays.

Dr. Szefler and his colleagues examined whether improvements in asthma impairment in young children reduced the cost burden of asthma. The study was the first to assess the economic burden of asthma in children aged 6-12 years with severe or difficult-to-treat illness as defined by the National Heart, Lung, and Blood Institute's guidelines, the researchers said.

The study included 628 children aged 6 years and older with severe or refractory asthma. At baseline, 386 children had very poorly controlled (VPC) asthma, 219 had not well-controlled (NWC) asthma, and 23 had well-controlled (WC) asthma. The children were a subgroup of the TENOR study, a large, observational study that assessed patients with severe and difficult-to-treat asthma. A total of 62% of the children were classified as VPC, the researchers noted.

The researchers compared the cumulative costs for patients who were consistently VPC at baseline, 12 months, and 24 months with the costs for patients who improved over the 24-month study period. Primary outcomes included school days lost, cost of asthma medications, unscheduled doctor visits, overnight hospital stays, and emergency department visits.

Overall, the cost of school and work days lost in the VPC group at baseline, 12 months, and 24 months was $3,087, $3,139, and $4,277, respectively. Those costs were significantly higher than for the NWC group ($369, $251, and $478, respectively) and the WC group ($0, $166, $0, respectively). The costs of school absences were measured using gender-specific dollar amounts to represent a parent's lost work day and adjusted to 2002 dollars.

The costs of medications were the next largest contributor to cost burden. Medication costs in the VPC group at baseline ($2,117), 12 months ($2,312), and 24 months ($2,298) were significantly higher than in the NWC group ($1,949, $1,987, and $1,995, respectively) and the WC group ($1,861, $1,640, and $1,605). The costs of medications were measured using the average recommended daily dose.

“The highest costs were associated with patients whose asthma impairment status remained consistently VPC,” the researchers wrote.

The study was sponsored by Genentech Inc. Dr. Szefler received funding from several organizations that are sponsored by the National Institutes of Health, as well as from several pharmaceutical companies.

Source Elsevier Global Medical News

NEW ORLEANS – Children's school absences and their parents' absences from work represented the greatest economic burden of impairment in children with severe asthma, according to data from an observational study of more than 600 children.

“Asthma costs in the United States have exceeded $10 billion,” said Dr. Stanley J. Szefler of National Jewish Health in Denver, and his colleagues at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. That figure includes $4.6 billion in indirect costs, such as mortality and lost school and work days, and $6.1 billion in direct costs, such as medications and hospital stays.

Dr. Szefler and his colleagues examined whether improvements in asthma impairment in young children reduced the cost burden of asthma. The study was the first to assess the economic burden of asthma in children aged 6-12 years with severe or difficult-to-treat illness as defined by the National Heart, Lung, and Blood Institute's guidelines, the researchers said.

The study included 628 children aged 6 years and older with severe or refractory asthma. At baseline, 386 children had very poorly controlled (VPC) asthma, 219 had not well-controlled (NWC) asthma, and 23 had well-controlled (WC) asthma. The children were a subgroup of the TENOR study, a large, observational study that assessed patients with severe and difficult-to-treat asthma. A total of 62% of the children were classified as VPC, the researchers noted.

The researchers compared the cumulative costs for patients who were consistently VPC at baseline, 12 months, and 24 months with the costs for patients who improved over the 24-month study period. Primary outcomes included school days lost, cost of asthma medications, unscheduled doctor visits, overnight hospital stays, and emergency department visits.

Overall, the cost of school and work days lost in the VPC group at baseline, 12 months, and 24 months was $3,087, $3,139, and $4,277, respectively. Those costs were significantly higher than for the NWC group ($369, $251, and $478, respectively) and the WC group ($0, $166, $0, respectively). The costs of school absences were measured using gender-specific dollar amounts to represent a parent's lost work day and adjusted to 2002 dollars.

The costs of medications were the next largest contributor to cost burden. Medication costs in the VPC group at baseline ($2,117), 12 months ($2,312), and 24 months ($2,298) were significantly higher than in the NWC group ($1,949, $1,987, and $1,995, respectively) and the WC group ($1,861, $1,640, and $1,605). The costs of medications were measured using the average recommended daily dose.

“The highest costs were associated with patients whose asthma impairment status remained consistently VPC,” the researchers wrote.

The study was sponsored by Genentech Inc. Dr. Szefler received funding from several organizations that are sponsored by the National Institutes of Health, as well as from several pharmaceutical companies.

Source Elsevier Global Medical News

Major Finding: Patients with chronic urticaria who responded to colchicine used significantly fewer steroids after starting colchicine than before starting it.

Data Source: A review of 55 patients who were treated with colchicine for chronic urticaria.

Disclosures: Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS — Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU from 2003 to 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University, Chicago, and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.

Skin biopsies from 27 patients—14 responders, 12 nonresponders, and 1 partial responder—showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

“Colchicine was particularly effective in patients with neutrophilic urticaria,” the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

“Colchicine has a relatively safe profile in chronic idiopathic urticaria,” the researchers noted.

Major Finding: Patients with chronic urticaria who responded to colchicine used significantly fewer steroids after starting colchicine than before starting it.

Data Source: A review of 55 patients who were treated with colchicine for chronic urticaria.

Disclosures: Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS — Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU from 2003 to 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University, Chicago, and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.

Skin biopsies from 27 patients—14 responders, 12 nonresponders, and 1 partial responder—showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

“Colchicine was particularly effective in patients with neutrophilic urticaria,” the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

“Colchicine has a relatively safe profile in chronic idiopathic urticaria,” the researchers noted.

Major Finding: Patients with chronic urticaria who responded to colchicine used significantly fewer steroids after starting colchicine than before starting it.

Data Source: A review of 55 patients who were treated with colchicine for chronic urticaria.

Disclosures: Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS — Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU from 2003 to 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University, Chicago, and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.

Skin biopsies from 27 patients—14 responders, 12 nonresponders, and 1 partial responder—showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

“Colchicine was particularly effective in patients with neutrophilic urticaria,” the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

“Colchicine has a relatively safe profile in chronic idiopathic urticaria,” the researchers noted.