Sherry Boschert

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

“There are a whole slew of orals coming,” Dr. Mariko Kita said in an interview at the meetingo “It's really exciting, but I think it will be challenging for the clinician” because there will be inadequate guidance on which drug or drugs to prioritize in treatment and how best to combine various therapies.

“I think it's going to be very intimidating, actually,” said Dr. Kita, director of the multiple sclerosis center at Virginia Mason Medical Center, Seattle.

She comoderated a session on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). (See story on p. 10.) The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

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

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

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

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

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

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

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

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

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

“I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points,” Dr. Kita said. “My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years.”

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

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

The challenge of the oral drugs will come from a lack of guidance on which drug or drugs to prioritize in treatment.

Source DR. KITA

Both teriflunomide doses reduced the annualized relapse rate by approximately 31%, compared with placebo.

Source DR. MILLER

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

“There are a whole slew of orals coming,” Dr. Mariko Kita said in an interview at the meetingo “It's really exciting, but I think it will be challenging for the clinician” because there will be inadequate guidance on which drug or drugs to prioritize in treatment and how best to combine various therapies.

“I think it's going to be very intimidating, actually,” said Dr. Kita, director of the multiple sclerosis center at Virginia Mason Medical Center, Seattle.

She comoderated a session on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). (See story on p. 10.) The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

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

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

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

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

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

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

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

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

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

“I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points,” Dr. Kita said. “My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years.”

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

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

The challenge of the oral drugs will come from a lack of guidance on which drug or drugs to prioritize in treatment.

Source DR. KITA

Both teriflunomide doses reduced the annualized relapse rate by approximately 31%, compared with placebo.

Source DR. MILLER

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

“There are a whole slew of orals coming,” Dr. Mariko Kita said in an interview at the meetingo “It's really exciting, but I think it will be challenging for the clinician” because there will be inadequate guidance on which drug or drugs to prioritize in treatment and how best to combine various therapies.

“I think it's going to be very intimidating, actually,” said Dr. Kita, director of the multiple sclerosis center at Virginia Mason Medical Center, Seattle.

She comoderated a session on multiple sclerosis trials that included a report on a pooled analysis of safety data on the only approved oral therapy for multiple sclerosis, fingolimod (Gilenya). (See story on p. 10.) The session also included positive phase III clinical trial results for the experimental oral therapy teriflunomide. Earlier in the meeting, separate investigators reported positive phase III clinical trial results for the experimental oral therapy laquinimod.

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

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

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

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

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

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

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

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

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

“I thought that the teriflunomide study was interesting. It was impressive to see that a fairly low dose like that, which seems to be very well tolerated, could have effects on both the MRI and on the clinical end points,” Dr. Kita said. “My concern for it is making sure that we understand what the impact is on the female population, on the childbearing years.”

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

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

The challenge of the oral drugs will come from a lack of guidance on which drug or drugs to prioritize in treatment.

Source DR. KITA

Both teriflunomide doses reduced the annualized relapse rate by approximately 31%, compared with placebo.

Source DR. MILLER

Major Finding: Immune responses to tetanus toxoid immunization occurred by 28 days in 15 of 16 patients taking natalizumab and in all 24 control patients.

Data Source: Open-label, multicenter, randomized study of 60 patients with relapsing-remitting multiple sclerosis.

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

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

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

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

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

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

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

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

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

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

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells. The investigators did not analyze humoral responses to live vaccines.

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

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

Source DR. PARDO

Major Finding: Immune responses to tetanus toxoid immunization occurred by 28 days in 15 of 16 patients taking natalizumab and in all 24 control patients.

Data Source: Open-label, multicenter, randomized study of 60 patients with relapsing-remitting multiple sclerosis.

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

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

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

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

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

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

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

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

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

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

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells. The investigators did not analyze humoral responses to live vaccines.

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

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

Source DR. PARDO

Major Finding: Immune responses to tetanus toxoid immunization occurred by 28 days in 15 of 16 patients taking natalizumab and in all 24 control patients.

Data Source: Open-label, multicenter, randomized study of 60 patients with relapsing-remitting multiple sclerosis.

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

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

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

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

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

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

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

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

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

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

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells. The investigators did not analyze humoral responses to live vaccines.

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

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

Source DR. PARDO

Major Finding: Transient reductions in heart rate on fingolimod hit a nadir at 4–5 hours after starting therapy and then increased to baseline over time, whereas reductions in atrioventricular conduction that began within the first 6 hours after starting therapy became attenuated and reached baseline levels by 1 month; increases in blood pressure of 1–3 mm Hg starting 2–6 months into treatment were sustained.

Data Source: Analysis of pooled data on 2,552 patients in two phase III clinical trials of fingolimod for relapsing-remitting multiple sclerosis.

Disclosures: The analysis was funded by Novartis, which markets fingolimod. Dr. DiMarco disclosed financial relationships with Novartis and other pharmaceutical companies. His associates in the study have been employees of Novartis, have held stock in the company, or disclosed other financial relationships with Novartis and other pharmaceutical companies.

HONOLULU – The first approved oral medication for multiple sclerosis causes transient reductions in heart rate and atrioventricular conduction and a sustained increase in blood pressure, according to investigators who analyzed pooled data from two phase III trials.

The cohorts from the two phase III clinical trials of fingolimod (Gilenya) for relapsing-remitting muscular sclerosis involved 854 patients treated with the currently approved dosage of fingolimod (0.5 mg/day), 849 patients on a higher dosage (1.25 mg/day), 418 patients on placebo, and 431 patients treated with weekly intramuscular injections of 30 mcg interferon beta-1a (Avonex) for 1–2 years.

The investigators measured vital signs hourly for 6 hours after starting treatment and at quarterly follow-up visits. Patients underwent an ECG before the first dose, 6 hours after treatment initiation, and if they developed symptoms during those 6 hours, as well as at selected follow-up visits. The studies did not use continuous ECG monitoring because they were designed to mimic treatment initiation in a neurologist's office.

Heart rates hit a nadir approximately 4–5 hours after starting fingolimod, and then began to increase, Dr. John DiMarco reported at the meetingo By 2 weeks after starting therapy, heart rates in the fingolimod groups were almost back to baseline, and thereafter were similar to baseline heart rates in the placebo group. As expected, inteferon therapy causedsome tachycardia.

In the first 6 hours of treatment, the lowest measured heart rate was below 35 beats per minute (bpm) in one patient on fingolimod 1.25 mg/day and one patient on interferon. Heart rates fell to as low as 35–39 bpm in six patients on fingolimod 1.25 mg/day, reported Dr. DiMarco, a cardiologist and professor of medicine at the University of Virginia, Charlottesville.

A heart rate nadir of 40–44 bpm was seen in approximately 1% of the low-dose fingolimod group, 3% of the high-dose fingolimod group, 0.2% of the placebo group, and no patients on interferon. A nadir of 45–54 bpm was measured in 18% on low-dose fingolimod, 29% on high-dose fingolimod, 6% on placebo, and 3% on interferon.

The lowest heart rate was 55–64 bpm in 49% on low-dose fingolimod, 50% on high-dose fingolimod, 37% on placebo, and 33% on interferon. Heart rates never fell below 65 bpm in 32% on low-dose fingolimod, 18% on high-dose fingolimod, 56% on placebo, and 64% on interferon.

Patients could be discharged at the 6-hour follow-up if any slowing in heart rate had started to return toward baseline, the heart rate was at least 55 bpm or greater than 80% of the baseline rate, and the patient had no symptoms related to bradycardia and no new, clinically relevant abnormality on ECG.

Observation beyond the 6-hour period was required in 12% on low-dose fingolimod, 18% on high-dose fingolimod, 3% on placebo, and 1% on interferon. Clinicians chose to hospitalize 2% of patients on fingolimod 0.5 mg/day, 3% of patients on 1.25 mg/day, 0.5% of patients on interferon, and none on placebo.

Symptoms of bradycardia were seen in 0.5% of patients on 0.5 mg/day fingolimod, 1% of patients on 1.25 mg/day, and no patients in other groups. All were described as mildly or moderately severe.

Conduction abnormalities also were more common within 6 hours of taking low-dose fingolimod (7%) or high-dose fingolimod (13%), compared with placebo or interferon (4% each). First-degree atrioventricular (AV) block was seen in 5% on low-dose fingolimod, 10% on high-dose fingolimod, 2% on placebo, and 3% on interferon. A Wenckebach second-degree AV block was seen in 0.2% on low-dose fingolimod, 0.7% on high-dose fingolimod, and no patients in the other groups. Two patients (0.2%) in the high-dose fingolimod group developed 2:1 second-degree AV block.

One patient in the low-dose fingolimod group and three in the high-dose fingolimod group were treated for heart rate or conduction abnormalities, although two of these patients were asymptomatic. Fingolimod was discontinued after the first dose in 1% of the high-dose group. In the others, the AV conduction changes attenuated with continued therapy and returned to baseline levels by 1 month.

The rise in blood pressure on fingolimod was small, but sustained and statistically significant, starting within 2–6 months of treatment initiation. Systolic and diastolic blood pressure increases averaged 1–2 mm Hg on 0.5 mg/day fingolimod and 1–3 mm Hg on 1.25 mg/day fingolimod, compared with placebo.

Rates of hypertension adverse events were higher in the fingolimod groups − 4% on the lower dose and 5% on the higher dose – compared with the placebo group (3%) or the interferon group (2%). The proportions of patients who needed antihypertensive therapy, however, were similar between groups: 5% on low-dose fingolimod, 6% on high-dose fingolimod, 6% on placebo, and 4% on interferon.

Patients who were treated responded to standard antihypertensive therapy.

Data for the analysis came from the Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis (FREEDOMS) trial and from the Trial Assessing Injectable Interferon vs. FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Both were international, multicenter, randomized double-blind trials.

Major Finding: Transient reductions in heart rate on fingolimod hit a nadir at 4–5 hours after starting therapy and then increased to baseline over time, whereas reductions in atrioventricular conduction that began within the first 6 hours after starting therapy became attenuated and reached baseline levels by 1 month; increases in blood pressure of 1–3 mm Hg starting 2–6 months into treatment were sustained.

Data Source: Analysis of pooled data on 2,552 patients in two phase III clinical trials of fingolimod for relapsing-remitting multiple sclerosis.

Disclosures: The analysis was funded by Novartis, which markets fingolimod. Dr. DiMarco disclosed financial relationships with Novartis and other pharmaceutical companies. His associates in the study have been employees of Novartis, have held stock in the company, or disclosed other financial relationships with Novartis and other pharmaceutical companies.

HONOLULU – The first approved oral medication for multiple sclerosis causes transient reductions in heart rate and atrioventricular conduction and a sustained increase in blood pressure, according to investigators who analyzed pooled data from two phase III trials.

The cohorts from the two phase III clinical trials of fingolimod (Gilenya) for relapsing-remitting muscular sclerosis involved 854 patients treated with the currently approved dosage of fingolimod (0.5 mg/day), 849 patients on a higher dosage (1.25 mg/day), 418 patients on placebo, and 431 patients treated with weekly intramuscular injections of 30 mcg interferon beta-1a (Avonex) for 1–2 years.

The investigators measured vital signs hourly for 6 hours after starting treatment and at quarterly follow-up visits. Patients underwent an ECG before the first dose, 6 hours after treatment initiation, and if they developed symptoms during those 6 hours, as well as at selected follow-up visits. The studies did not use continuous ECG monitoring because they were designed to mimic treatment initiation in a neurologist's office.

Heart rates hit a nadir approximately 4–5 hours after starting fingolimod, and then began to increase, Dr. John DiMarco reported at the meetingo By 2 weeks after starting therapy, heart rates in the fingolimod groups were almost back to baseline, and thereafter were similar to baseline heart rates in the placebo group. As expected, inteferon therapy causedsome tachycardia.

In the first 6 hours of treatment, the lowest measured heart rate was below 35 beats per minute (bpm) in one patient on fingolimod 1.25 mg/day and one patient on interferon. Heart rates fell to as low as 35–39 bpm in six patients on fingolimod 1.25 mg/day, reported Dr. DiMarco, a cardiologist and professor of medicine at the University of Virginia, Charlottesville.

A heart rate nadir of 40–44 bpm was seen in approximately 1% of the low-dose fingolimod group, 3% of the high-dose fingolimod group, 0.2% of the placebo group, and no patients on interferon. A nadir of 45–54 bpm was measured in 18% on low-dose fingolimod, 29% on high-dose fingolimod, 6% on placebo, and 3% on interferon.

The lowest heart rate was 55–64 bpm in 49% on low-dose fingolimod, 50% on high-dose fingolimod, 37% on placebo, and 33% on interferon. Heart rates never fell below 65 bpm in 32% on low-dose fingolimod, 18% on high-dose fingolimod, 56% on placebo, and 64% on interferon.

Patients could be discharged at the 6-hour follow-up if any slowing in heart rate had started to return toward baseline, the heart rate was at least 55 bpm or greater than 80% of the baseline rate, and the patient had no symptoms related to bradycardia and no new, clinically relevant abnormality on ECG.

Observation beyond the 6-hour period was required in 12% on low-dose fingolimod, 18% on high-dose fingolimod, 3% on placebo, and 1% on interferon. Clinicians chose to hospitalize 2% of patients on fingolimod 0.5 mg/day, 3% of patients on 1.25 mg/day, 0.5% of patients on interferon, and none on placebo.

Symptoms of bradycardia were seen in 0.5% of patients on 0.5 mg/day fingolimod, 1% of patients on 1.25 mg/day, and no patients in other groups. All were described as mildly or moderately severe.

Conduction abnormalities also were more common within 6 hours of taking low-dose fingolimod (7%) or high-dose fingolimod (13%), compared with placebo or interferon (4% each). First-degree atrioventricular (AV) block was seen in 5% on low-dose fingolimod, 10% on high-dose fingolimod, 2% on placebo, and 3% on interferon. A Wenckebach second-degree AV block was seen in 0.2% on low-dose fingolimod, 0.7% on high-dose fingolimod, and no patients in the other groups. Two patients (0.2%) in the high-dose fingolimod group developed 2:1 second-degree AV block.

One patient in the low-dose fingolimod group and three in the high-dose fingolimod group were treated for heart rate or conduction abnormalities, although two of these patients were asymptomatic. Fingolimod was discontinued after the first dose in 1% of the high-dose group. In the others, the AV conduction changes attenuated with continued therapy and returned to baseline levels by 1 month.

The rise in blood pressure on fingolimod was small, but sustained and statistically significant, starting within 2–6 months of treatment initiation. Systolic and diastolic blood pressure increases averaged 1–2 mm Hg on 0.5 mg/day fingolimod and 1–3 mm Hg on 1.25 mg/day fingolimod, compared with placebo.

Rates of hypertension adverse events were higher in the fingolimod groups − 4% on the lower dose and 5% on the higher dose – compared with the placebo group (3%) or the interferon group (2%). The proportions of patients who needed antihypertensive therapy, however, were similar between groups: 5% on low-dose fingolimod, 6% on high-dose fingolimod, 6% on placebo, and 4% on interferon.

Patients who were treated responded to standard antihypertensive therapy.

Data for the analysis came from the Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis (FREEDOMS) trial and from the Trial Assessing Injectable Interferon vs. FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Both were international, multicenter, randomized double-blind trials.

Major Finding: Transient reductions in heart rate on fingolimod hit a nadir at 4–5 hours after starting therapy and then increased to baseline over time, whereas reductions in atrioventricular conduction that began within the first 6 hours after starting therapy became attenuated and reached baseline levels by 1 month; increases in blood pressure of 1–3 mm Hg starting 2–6 months into treatment were sustained.

Data Source: Analysis of pooled data on 2,552 patients in two phase III clinical trials of fingolimod for relapsing-remitting multiple sclerosis.

Disclosures: The analysis was funded by Novartis, which markets fingolimod. Dr. DiMarco disclosed financial relationships with Novartis and other pharmaceutical companies. His associates in the study have been employees of Novartis, have held stock in the company, or disclosed other financial relationships with Novartis and other pharmaceutical companies.

HONOLULU – The first approved oral medication for multiple sclerosis causes transient reductions in heart rate and atrioventricular conduction and a sustained increase in blood pressure, according to investigators who analyzed pooled data from two phase III trials.

The cohorts from the two phase III clinical trials of fingolimod (Gilenya) for relapsing-remitting muscular sclerosis involved 854 patients treated with the currently approved dosage of fingolimod (0.5 mg/day), 849 patients on a higher dosage (1.25 mg/day), 418 patients on placebo, and 431 patients treated with weekly intramuscular injections of 30 mcg interferon beta-1a (Avonex) for 1–2 years.

The investigators measured vital signs hourly for 6 hours after starting treatment and at quarterly follow-up visits. Patients underwent an ECG before the first dose, 6 hours after treatment initiation, and if they developed symptoms during those 6 hours, as well as at selected follow-up visits. The studies did not use continuous ECG monitoring because they were designed to mimic treatment initiation in a neurologist's office.

Heart rates hit a nadir approximately 4–5 hours after starting fingolimod, and then began to increase, Dr. John DiMarco reported at the meetingo By 2 weeks after starting therapy, heart rates in the fingolimod groups were almost back to baseline, and thereafter were similar to baseline heart rates in the placebo group. As expected, inteferon therapy causedsome tachycardia.

In the first 6 hours of treatment, the lowest measured heart rate was below 35 beats per minute (bpm) in one patient on fingolimod 1.25 mg/day and one patient on interferon. Heart rates fell to as low as 35–39 bpm in six patients on fingolimod 1.25 mg/day, reported Dr. DiMarco, a cardiologist and professor of medicine at the University of Virginia, Charlottesville.

A heart rate nadir of 40–44 bpm was seen in approximately 1% of the low-dose fingolimod group, 3% of the high-dose fingolimod group, 0.2% of the placebo group, and no patients on interferon. A nadir of 45–54 bpm was measured in 18% on low-dose fingolimod, 29% on high-dose fingolimod, 6% on placebo, and 3% on interferon.

The lowest heart rate was 55–64 bpm in 49% on low-dose fingolimod, 50% on high-dose fingolimod, 37% on placebo, and 33% on interferon. Heart rates never fell below 65 bpm in 32% on low-dose fingolimod, 18% on high-dose fingolimod, 56% on placebo, and 64% on interferon.

Patients could be discharged at the 6-hour follow-up if any slowing in heart rate had started to return toward baseline, the heart rate was at least 55 bpm or greater than 80% of the baseline rate, and the patient had no symptoms related to bradycardia and no new, clinically relevant abnormality on ECG.

Observation beyond the 6-hour period was required in 12% on low-dose fingolimod, 18% on high-dose fingolimod, 3% on placebo, and 1% on interferon. Clinicians chose to hospitalize 2% of patients on fingolimod 0.5 mg/day, 3% of patients on 1.25 mg/day, 0.5% of patients on interferon, and none on placebo.

Symptoms of bradycardia were seen in 0.5% of patients on 0.5 mg/day fingolimod, 1% of patients on 1.25 mg/day, and no patients in other groups. All were described as mildly or moderately severe.

Conduction abnormalities also were more common within 6 hours of taking low-dose fingolimod (7%) or high-dose fingolimod (13%), compared with placebo or interferon (4% each). First-degree atrioventricular (AV) block was seen in 5% on low-dose fingolimod, 10% on high-dose fingolimod, 2% on placebo, and 3% on interferon. A Wenckebach second-degree AV block was seen in 0.2% on low-dose fingolimod, 0.7% on high-dose fingolimod, and no patients in the other groups. Two patients (0.2%) in the high-dose fingolimod group developed 2:1 second-degree AV block.

One patient in the low-dose fingolimod group and three in the high-dose fingolimod group were treated for heart rate or conduction abnormalities, although two of these patients were asymptomatic. Fingolimod was discontinued after the first dose in 1% of the high-dose group. In the others, the AV conduction changes attenuated with continued therapy and returned to baseline levels by 1 month.

The rise in blood pressure on fingolimod was small, but sustained and statistically significant, starting within 2–6 months of treatment initiation. Systolic and diastolic blood pressure increases averaged 1–2 mm Hg on 0.5 mg/day fingolimod and 1–3 mm Hg on 1.25 mg/day fingolimod, compared with placebo.

Rates of hypertension adverse events were higher in the fingolimod groups − 4% on the lower dose and 5% on the higher dose – compared with the placebo group (3%) or the interferon group (2%). The proportions of patients who needed antihypertensive therapy, however, were similar between groups: 5% on low-dose fingolimod, 6% on high-dose fingolimod, 6% on placebo, and 4% on interferon.

Patients who were treated responded to standard antihypertensive therapy.

Data for the analysis came from the Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis (FREEDOMS) trial and from the Trial Assessing Injectable Interferon vs. FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Both were international, multicenter, randomized double-blind trials.

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

For patients with spondyloarthritis who smoke, it's never too early to quit, according to new data presented by Dr. Pedro Machado.

An analysis of data on 708 patients in a multicenter study found that patients with axial spondyloarthritis (SpA) who smoked were more likely than nonsmokers with the disease to have earlier onset of inflammatory back pain, greater disease activity, increased axial inflammation on MRI, increased axial structural damage on MRI and radiographs, poorer function, and worse quality of life.

“Taking into account that smoking is a potentially modifiable lifestyle factor, axial spondyloarthritis patients that smoke should be strongly advised to quit this habit,” Dr. Machado said in an interview.

Previous studies focused on ankylosing spondylitis and showed that smokers had more limited physical function and increased radiographic damage compared with nonsmokers.

The current analysis focused on the early disease stage of axial SpA, said Dr. Machado of Coimbra (Portugal) University Hospital, who is currently a physician-researcher at Leiden (the Netherlands) University Center. The analysis of data from the Devenir des Spondyl-arthropathies Indifférenciées Récente (DESIR) study covered 654 patients who fulfilled criteria for axial SpA on at least one of several criteria sets.

On average, the onset of inflammatory back pain occurred 1.5 years earlier in the 37% of patients who currently smoked compared with nonsmokers, after adjustment. Smoking was associated with significantly higher disease activity scores on the Ankylosing Spondylitis Disease Activity Index (a 0.2-point average worsening on the 10-point scale) and the Bath Ankylosing Spondylitis Disease Activity Index (a 0.5-point average worsening on the 10-point scale), and with worse functional status scores on the Bath Ankylosing Spondylitis Functional Index (a 0.4-point average worsening on the 10-point scale).

Among the MRI findings, smokers had a 57% increased likelihood of inflammation of the sacroiliac joints and double the risk for spine inflammation compared with nonsmokers, Dr. Machado and his associates found. Smokers were 54% more likely to show structural lesions of the sacroiliac joints and twice as likely to show structural lesions of the spine on MRI compared with nonsmokers. Modified Stroke Ankylosing Spondylitis Spinal Scores were 0.5 points worse on average in smokers than in nonsmokers, a statistically significant difference.

Health-related quality of life was poorer in smokers than nonsmokers, evidenced by an average 1.4-point worsening on the Ankylosing Spondylitis Quality of Life score, a 5-point worsening on the 36-item Short Form Health Survey (SF-36) physical component score, and a 6-point worsening on the SF-36 mental component score.

The cohort was relatively young (mean age, 34 years; median age, 33 years) with a short duration of symptoms (mean, 1.5 years; median, 1.4 years).

Pfizer, which markets a medication for ankylosing spondylitis, funded the DESIR study with an unrestricted grant and was not involved in the analyses. Dr. Machado said the investigators had no relevant financial disclosures.

Smokers were 54% more likely to have lesions of the sacroiliac joints.

Source © pmphoto/iStockphoto.com

Major Finding: After testing negative to skin prick tests with influenza vaccine, the children were given the full, age-appropriate vaccine dose in one injection. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Data Source: Prospective case series of 101 patients followed at Duke University's allergy/immunology clinic.

Disclosures: Dr. Boden said he had no relevant financial disclosures. Dr. Boden is sponsored by the U.S. Air Force. The views expressed are his and do not necessarily reflect the official policy of the Air Force, the Department of Defense, or the U.S. government.

SAN FRANCISCO – Influenza vaccine was safely administered to 101 children with severe egg allergy who had negative skin prick test results with the vaccine, a study has shown.

All patients had been strictly avoiding egg in their diet because of allergy confirmed by a history of reaction to egg, skin prick testing, and/or egg-specific IgE. Among 50 children who had a history of systemic reactions to egg, 24 developed urticaria, 22 had a gastroenterologic reaction, and 4 had respiratory reactions. Thirty-one children had a history of eczema after ingesting egg, and 20 had no history of ingestion at the time of diagnosis.

All underwent skin prick testing with the full-strength influenza vaccine along with saline and histamine controls. The tests used vaccine for seasonal or novel H1N1 influenza virus or both.

The vaccines came from three different manufacturers, with the majority from a manufacturer who had been known to produce several vaccine lots with ovalbumin content greater than 1.2 mcg/mL, Dr. Stephen R. Boden said in a poster presentation at the meeting.

None of the children developed a wheal at the vaccine skin prick site that was at least 3 mm larger than the wheal from the saline control, so all had negative skin prick test results, said Dr. Boden, an allergy fellow at Duke University, Durham, N.C. Tests were considered valid with at least a 3-mm wheal from the histamine control.

All patients then were given the full, age-appropriate vaccine dose in one injection and were observed in the clinic for 30 minutes. Two reactions were reported 24 hours after vaccination. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Patients who had tolerated vaccination were told to get booster doses from their primary care physicians, but could get the booster doses in the university's allergy/immunology clinic if they preferred. In all, the children received 211 vaccine doses, Dr. Boden reported.

The mean age of the cohort was 4 years (range, 7 months to 18 years). Wheals from egg skin prick testing averaged 9 mm in diameter (range, 1–28 mm). The mean egg-specific IgE level was 21 kU/L, with a range of less than 0.35 to more than 100 kU/L.

The Centers for Disease Control and Prevention recommend yearly influenza vaccination for all children older than 6 months. Current recommendations from the American Academy of Pediatrics say that children with severe egg allergy generally should not be given influenza vaccine because of the risk of reaction and other reasons, Dr. Boden said. Published schedules for giving influenza vaccine to some severely egg-allergic patients recommend skin prick testing, intradermal testing, and graded vaccine injection (J. Pediatr. 1985;106:931-3).

Had any of the patients in the current study had a positive skin prick test result, the patient would have received the vaccine split into 10% of the age-appropriate dose in the first injection followed 30 minutes later by the remaining 90% of the dose.

Major Finding: After testing negative to skin prick tests with influenza vaccine, the children were given the full, age-appropriate vaccine dose in one injection. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Data Source: Prospective case series of 101 patients followed at Duke University's allergy/immunology clinic.

Disclosures: Dr. Boden said he had no relevant financial disclosures. Dr. Boden is sponsored by the U.S. Air Force. The views expressed are his and do not necessarily reflect the official policy of the Air Force, the Department of Defense, or the U.S. government.

SAN FRANCISCO – Influenza vaccine was safely administered to 101 children with severe egg allergy who had negative skin prick test results with the vaccine, a study has shown.

All patients had been strictly avoiding egg in their diet because of allergy confirmed by a history of reaction to egg, skin prick testing, and/or egg-specific IgE. Among 50 children who had a history of systemic reactions to egg, 24 developed urticaria, 22 had a gastroenterologic reaction, and 4 had respiratory reactions. Thirty-one children had a history of eczema after ingesting egg, and 20 had no history of ingestion at the time of diagnosis.

All underwent skin prick testing with the full-strength influenza vaccine along with saline and histamine controls. The tests used vaccine for seasonal or novel H1N1 influenza virus or both.

The vaccines came from three different manufacturers, with the majority from a manufacturer who had been known to produce several vaccine lots with ovalbumin content greater than 1.2 mcg/mL, Dr. Stephen R. Boden said in a poster presentation at the meeting.

None of the children developed a wheal at the vaccine skin prick site that was at least 3 mm larger than the wheal from the saline control, so all had negative skin prick test results, said Dr. Boden, an allergy fellow at Duke University, Durham, N.C. Tests were considered valid with at least a 3-mm wheal from the histamine control.

All patients then were given the full, age-appropriate vaccine dose in one injection and were observed in the clinic for 30 minutes. Two reactions were reported 24 hours after vaccination. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Patients who had tolerated vaccination were told to get booster doses from their primary care physicians, but could get the booster doses in the university's allergy/immunology clinic if they preferred. In all, the children received 211 vaccine doses, Dr. Boden reported.

The mean age of the cohort was 4 years (range, 7 months to 18 years). Wheals from egg skin prick testing averaged 9 mm in diameter (range, 1–28 mm). The mean egg-specific IgE level was 21 kU/L, with a range of less than 0.35 to more than 100 kU/L.

The Centers for Disease Control and Prevention recommend yearly influenza vaccination for all children older than 6 months. Current recommendations from the American Academy of Pediatrics say that children with severe egg allergy generally should not be given influenza vaccine because of the risk of reaction and other reasons, Dr. Boden said. Published schedules for giving influenza vaccine to some severely egg-allergic patients recommend skin prick testing, intradermal testing, and graded vaccine injection (J. Pediatr. 1985;106:931-3).

Had any of the patients in the current study had a positive skin prick test result, the patient would have received the vaccine split into 10% of the age-appropriate dose in the first injection followed 30 minutes later by the remaining 90% of the dose.

Major Finding: After testing negative to skin prick tests with influenza vaccine, the children were given the full, age-appropriate vaccine dose in one injection. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Data Source: Prospective case series of 101 patients followed at Duke University's allergy/immunology clinic.

Disclosures: Dr. Boden said he had no relevant financial disclosures. Dr. Boden is sponsored by the U.S. Air Force. The views expressed are his and do not necessarily reflect the official policy of the Air Force, the Department of Defense, or the U.S. government.

SAN FRANCISCO – Influenza vaccine was safely administered to 101 children with severe egg allergy who had negative skin prick test results with the vaccine, a study has shown.

All patients had been strictly avoiding egg in their diet because of allergy confirmed by a history of reaction to egg, skin prick testing, and/or egg-specific IgE. Among 50 children who had a history of systemic reactions to egg, 24 developed urticaria, 22 had a gastroenterologic reaction, and 4 had respiratory reactions. Thirty-one children had a history of eczema after ingesting egg, and 20 had no history of ingestion at the time of diagnosis.

All underwent skin prick testing with the full-strength influenza vaccine along with saline and histamine controls. The tests used vaccine for seasonal or novel H1N1 influenza virus or both.

The vaccines came from three different manufacturers, with the majority from a manufacturer who had been known to produce several vaccine lots with ovalbumin content greater than 1.2 mcg/mL, Dr. Stephen R. Boden said in a poster presentation at the meeting.

None of the children developed a wheal at the vaccine skin prick site that was at least 3 mm larger than the wheal from the saline control, so all had negative skin prick test results, said Dr. Boden, an allergy fellow at Duke University, Durham, N.C. Tests were considered valid with at least a 3-mm wheal from the histamine control.

All patients then were given the full, age-appropriate vaccine dose in one injection and were observed in the clinic for 30 minutes. Two reactions were reported 24 hours after vaccination. One patient had a large local reaction, and another developed cellulitis at the injection site. There were no systemic reactions.

Patients who had tolerated vaccination were told to get booster doses from their primary care physicians, but could get the booster doses in the university's allergy/immunology clinic if they preferred. In all, the children received 211 vaccine doses, Dr. Boden reported.

The mean age of the cohort was 4 years (range, 7 months to 18 years). Wheals from egg skin prick testing averaged 9 mm in diameter (range, 1–28 mm). The mean egg-specific IgE level was 21 kU/L, with a range of less than 0.35 to more than 100 kU/L.

The Centers for Disease Control and Prevention recommend yearly influenza vaccination for all children older than 6 months. Current recommendations from the American Academy of Pediatrics say that children with severe egg allergy generally should not be given influenza vaccine because of the risk of reaction and other reasons, Dr. Boden said. Published schedules for giving influenza vaccine to some severely egg-allergic patients recommend skin prick testing, intradermal testing, and graded vaccine injection (J. Pediatr. 1985;106:931-3).

Had any of the patients in the current study had a positive skin prick test result, the patient would have received the vaccine split into 10% of the age-appropriate dose in the first injection followed 30 minutes later by the remaining 90% of the dose.

LAS VEGAS – Most patients taking etanercept or adalimumab for psoriasis can interrupt therapy and restart when needed, but not all of them will get as good a response the second time around.

With either biologic agent, response rates are slightly higher in patients on continuous therapy than in patients who stop and restart therapy, separate speakers said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

But for a patient who plans to travel and doesn’t want to take along a case of syringes for etanercept injections, a physician can advise that the psoriasis probably won’t return for a few months after stopping the drug, and that restarting etanercept probably will produce a fairly good response, said Dr. Francisco A. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Phase III trials of both drugs included arms that allowed withdrawal from therapy and the possibility of retreatment. "This is what happens in real life," he said. "Patients lose their insurance, or they don’t take their medicine, or they have some kind of surgery. Surgeons won’t operate unless the patients discontinue the drug."

On any dosage of etanercept, patients who discontinued the drug lost about half of the improvement they had gained on therapy at approximately 3 months after stopping treatment.

"Do patients flare faster than this in real life? Yes, but in the studies at least we have some data to suggest that it takes a while for patients’ psoriasis to come back," Dr. Kerdel said. Patients who restarted treatment and again discontinued etanercept had similar responses.

A separate randomized, open-label study comparing continuous versus interrupted etanercept therapy in more than 2,500 psoriasis patients showed there was a better response rate after 24 weeks in the continuous-treatment group (71%) than with interrupted therapy (60%), he said (J. Am. Acad. Dermatol. 2007;56:598-603).

"While you can stop and restart, it’s probably not a good idea," Dr. Kerdel said. "I don’t think you should treat psoriasis like you do a light switch and turn it on and off."

Several long-term safety studies that have followed hundreds of patients out to 3 years suggest that continuous etanercept remains efficacious and there is no cumulative toxicity.

Three-year data on adalimumab also suggest that response rates stabilize over time and that no new toxicities emerge, but for both biologic drugs these may be factors of patient selection, Dr. Kenneth B. Gordon said in a separate presentation.

"I would argue that with every medication there is some lost effect over time," said Dr. Gordon of the University of Chicago. Response rates are more variable initially but tend to stabilize over time, because the patients who stay on treatment tend to be the ones who are doing well on it. "You develop a high responding population that’s going to be able to maintain that response over time," he said.

This means, though, that you can tell patients that "if you get them through the first year, the likelihood is that the drug is going to keep on working," Dr. Gordon said.

An unpublished subanalysis by other investigators of phase III trial data on adalimumab looked at patients with a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 33 weeks of adalimumab therapy. Among 227 patients who stopped and restarted adalimumab, retreatment recaptured the therapeutic effects, but never quite to the levels seen in 233 patients on continuous treatment. At week 108, 73% on retreatment and 75% on continuous treatment had a PASI 75.

"It’s important to tell patients that when you stop medication, you can restart and there’s a real good chance that you will recapture response, but it’s not in 100% of patients," Dr. Gordon said.

A separate subanalysis of the same data suggests that patients whose psoriasis returns most vigorously after stopping adalimumab are the least likely to recapture their previous response to treatment fully after restarting the drug. Among 70 whose PASI scores fell below 60 before restarting adalimumab, 58% had a PASI 75 at week 108. In 55 patients with a PASI score of 60-74 when restarting adalimumab, 81% achieved a PASI 75 at week 108. In 102 patients with a PASI score of 75-100 when restarting the drug, 86% had a PASI 75 at week 108, he said.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel and Dr. Gordon have been speakers or consultants for, or have received grants from, Amgen (which markets etanercept), Abbott (which markets adalimumab), Centocor, and Merck. Dr. Kerdel also has had associations with Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth. Dr. Gordon has had associations with Lilly, Pfizer, Celgene, and Medicis.

LAS VEGAS – Most patients taking etanercept or adalimumab for psoriasis can interrupt therapy and restart when needed, but not all of them will get as good a response the second time around.

With either biologic agent, response rates are slightly higher in patients on continuous therapy than in patients who stop and restart therapy, separate speakers said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

But for a patient who plans to travel and doesn’t want to take along a case of syringes for etanercept injections, a physician can advise that the psoriasis probably won’t return for a few months after stopping the drug, and that restarting etanercept probably will produce a fairly good response, said Dr. Francisco A. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Phase III trials of both drugs included arms that allowed withdrawal from therapy and the possibility of retreatment. "This is what happens in real life," he said. "Patients lose their insurance, or they don’t take their medicine, or they have some kind of surgery. Surgeons won’t operate unless the patients discontinue the drug."

On any dosage of etanercept, patients who discontinued the drug lost about half of the improvement they had gained on therapy at approximately 3 months after stopping treatment.

"Do patients flare faster than this in real life? Yes, but in the studies at least we have some data to suggest that it takes a while for patients’ psoriasis to come back," Dr. Kerdel said. Patients who restarted treatment and again discontinued etanercept had similar responses.

A separate randomized, open-label study comparing continuous versus interrupted etanercept therapy in more than 2,500 psoriasis patients showed there was a better response rate after 24 weeks in the continuous-treatment group (71%) than with interrupted therapy (60%), he said (J. Am. Acad. Dermatol. 2007;56:598-603).

"While you can stop and restart, it’s probably not a good idea," Dr. Kerdel said. "I don’t think you should treat psoriasis like you do a light switch and turn it on and off."

Several long-term safety studies that have followed hundreds of patients out to 3 years suggest that continuous etanercept remains efficacious and there is no cumulative toxicity.

Three-year data on adalimumab also suggest that response rates stabilize over time and that no new toxicities emerge, but for both biologic drugs these may be factors of patient selection, Dr. Kenneth B. Gordon said in a separate presentation.

"I would argue that with every medication there is some lost effect over time," said Dr. Gordon of the University of Chicago. Response rates are more variable initially but tend to stabilize over time, because the patients who stay on treatment tend to be the ones who are doing well on it. "You develop a high responding population that’s going to be able to maintain that response over time," he said.

This means, though, that you can tell patients that "if you get them through the first year, the likelihood is that the drug is going to keep on working," Dr. Gordon said.

An unpublished subanalysis by other investigators of phase III trial data on adalimumab looked at patients with a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 33 weeks of adalimumab therapy. Among 227 patients who stopped and restarted adalimumab, retreatment recaptured the therapeutic effects, but never quite to the levels seen in 233 patients on continuous treatment. At week 108, 73% on retreatment and 75% on continuous treatment had a PASI 75.

"It’s important to tell patients that when you stop medication, you can restart and there’s a real good chance that you will recapture response, but it’s not in 100% of patients," Dr. Gordon said.

A separate subanalysis of the same data suggests that patients whose psoriasis returns most vigorously after stopping adalimumab are the least likely to recapture their previous response to treatment fully after restarting the drug. Among 70 whose PASI scores fell below 60 before restarting adalimumab, 58% had a PASI 75 at week 108. In 55 patients with a PASI score of 60-74 when restarting adalimumab, 81% achieved a PASI 75 at week 108. In 102 patients with a PASI score of 75-100 when restarting the drug, 86% had a PASI 75 at week 108, he said.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel and Dr. Gordon have been speakers or consultants for, or have received grants from, Amgen (which markets etanercept), Abbott (which markets adalimumab), Centocor, and Merck. Dr. Kerdel also has had associations with Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth. Dr. Gordon has had associations with Lilly, Pfizer, Celgene, and Medicis.

LAS VEGAS – Most patients taking etanercept or adalimumab for psoriasis can interrupt therapy and restart when needed, but not all of them will get as good a response the second time around.

With either biologic agent, response rates are slightly higher in patients on continuous therapy than in patients who stop and restart therapy, separate speakers said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

But for a patient who plans to travel and doesn’t want to take along a case of syringes for etanercept injections, a physician can advise that the psoriasis probably won’t return for a few months after stopping the drug, and that restarting etanercept probably will produce a fairly good response, said Dr. Francisco A. Kerdel, director of the dermatology inpatient service at University of Miami Hospital.

Phase III trials of both drugs included arms that allowed withdrawal from therapy and the possibility of retreatment. "This is what happens in real life," he said. "Patients lose their insurance, or they don’t take their medicine, or they have some kind of surgery. Surgeons won’t operate unless the patients discontinue the drug."

On any dosage of etanercept, patients who discontinued the drug lost about half of the improvement they had gained on therapy at approximately 3 months after stopping treatment.

"Do patients flare faster than this in real life? Yes, but in the studies at least we have some data to suggest that it takes a while for patients’ psoriasis to come back," Dr. Kerdel said. Patients who restarted treatment and again discontinued etanercept had similar responses.

A separate randomized, open-label study comparing continuous versus interrupted etanercept therapy in more than 2,500 psoriasis patients showed there was a better response rate after 24 weeks in the continuous-treatment group (71%) than with interrupted therapy (60%), he said (J. Am. Acad. Dermatol. 2007;56:598-603).

"While you can stop and restart, it’s probably not a good idea," Dr. Kerdel said. "I don’t think you should treat psoriasis like you do a light switch and turn it on and off."

Several long-term safety studies that have followed hundreds of patients out to 3 years suggest that continuous etanercept remains efficacious and there is no cumulative toxicity.

Three-year data on adalimumab also suggest that response rates stabilize over time and that no new toxicities emerge, but for both biologic drugs these may be factors of patient selection, Dr. Kenneth B. Gordon said in a separate presentation.

"I would argue that with every medication there is some lost effect over time," said Dr. Gordon of the University of Chicago. Response rates are more variable initially but tend to stabilize over time, because the patients who stay on treatment tend to be the ones who are doing well on it. "You develop a high responding population that’s going to be able to maintain that response over time," he said.

This means, though, that you can tell patients that "if you get them through the first year, the likelihood is that the drug is going to keep on working," Dr. Gordon said.

An unpublished subanalysis by other investigators of phase III trial data on adalimumab looked at patients with a 75% improvement in Psoriasis Area and Severity Index (PASI 75) score after 33 weeks of adalimumab therapy. Among 227 patients who stopped and restarted adalimumab, retreatment recaptured the therapeutic effects, but never quite to the levels seen in 233 patients on continuous treatment. At week 108, 73% on retreatment and 75% on continuous treatment had a PASI 75.

"It’s important to tell patients that when you stop medication, you can restart and there’s a real good chance that you will recapture response, but it’s not in 100% of patients," Dr. Gordon said.

A separate subanalysis of the same data suggests that patients whose psoriasis returns most vigorously after stopping adalimumab are the least likely to recapture their previous response to treatment fully after restarting the drug. Among 70 whose PASI scores fell below 60 before restarting adalimumab, 58% had a PASI 75 at week 108. In 55 patients with a PASI score of 60-74 when restarting adalimumab, 81% achieved a PASI 75 at week 108. In 102 patients with a PASI score of 75-100 when restarting the drug, 86% had a PASI 75 at week 108, he said.

SDEF and this news organization are owned by Elsevier. Dr. Kerdel and Dr. Gordon have been speakers or consultants for, or have received grants from, Amgen (which markets etanercept), Abbott (which markets adalimumab), Centocor, and Merck. Dr. Kerdel also has had associations with Eisai, Astellas, Genentech, Stiefel, Novartis, and Wyeth. Dr. Gordon has had associations with Lilly, Pfizer, Celgene, and Medicis.

SAN FRANCISCO - Off-label pretreatment with the biologic drug omalizumab enabled relatively rapid oral desensitization to milk allergy in a pilot study of 11 children.

One patient who dropped out of the study after 1 day of desensitization was later diagnosed as having abdominal migraines. Among the remaining 10 patients, 9 tolerated desensitization to a dose of 2,000 mg/day of powdered milk within 7-10 weeks. These nine children then passed a double-blind, placebo-controlled food challenge at weeks 24-27 and have since been consuming 8-12 ounces of milk in their daily diets at home, Dr. Kari C. Nadeau said at the meeting.

Responses to desensitization were seen within 7-11 weeks, compared with 15-16 weeks in previous studies of protocols for oral desensitization to food allergy, reported Dr. Nadeau of Stanford (Calif.) University, and her associates.

The study recruited patients at Stanford and at Children's Hospital, Boston, who had a history of acute reactions to cooked and uncooked milk, mean wheal sizes of 22 mm after skin testing, mean milk-specific IgE measurements of 98 kU/L, and mean total IgE measurements of 701 kU/L. Patients averaged 10 years in age.

For 9 weeks they took omalizumab (Xolair), an anti-IgE monoclonal antibody drug that is approved to treat patients 12 years or older with moderate-to-severe persistent allergic asthma that is insufficiently controlled by inhaled corticosteroids.

Then, in 1 day they underwent a "rush" desensitization to oral doses of 1,000 mg of milk powder, to a cumulative dose of 2,000 mg. Seven patients passed the 1-day desensitization.

From weeks 9 to 16, they continued on omalizumab and the dose of powdered milk was increased weekly under supervision in the medical centers.

Patients stopped taking omalizumab at week 16 but continued taking a maintenance dose of 2,000 mg/day of powdered milk at home, with regular clinic visits for assessments.

Nine of the remaining 10 patients reached an oral daily dose of 2,000 mg of powdered milk (the primary end point) by week 20, and the 10th patient tolerated a dose of 1,200 mg/day.

Nine patients passed a double-blind, placebo-controlled food challenge to up to 3,000 mg of milk and a cumulative dose of 7,200 mg at weeks 24-27. The day after passing the double-blind food challenge, the nine patients began tolerating 8-12 ounces of milk per day in their diet, including ice cream, pizza, and yogurt, Dr. Nadeau said.

Dr. Dale T. Umetsu of Harvard Medical School, Boston, who was the principal investigator in the study, said in an interview that the combination of omalizumab and oral desensitization "allowed us to move relatively quickly in increasing the dose of milk from a very small dose to a very large maintenance dose of milk."

At some point during the study, each of the 11 patients developed a reaction to the milk, and most had 10-11 reactions over the course of the study. Patients have been followed for up to 52 weeks.

The children received a mean of 209 milk doses each. Among the 2,301 total doses, 41 (2%) generated reactions, most of which were mild. Epinephrine was administered for three of the reactions. Most reactions consisted of pruritus, urticaria, or abdominal pain, all of which were treatable, Dr. Nadeau said.

Among 29 reactions with mild symptoms, 14 occurred on the rush-desensitization day, 10 occurred during the weekly dose-escalation phase, and 5 happened during the maintenance phase.

Among eight reactions with moderate symptoms, five occurred on the rush desensitization day, one occurred during the weekly dose-escalation phase, and two occurred during the maintenance phase.

The four reactions with severe symptoms included one patient with tongue swelling and another with disseminated urticaria on the rush-desensitization day, one patient with severe abdominal pain during the weekly dose-escalation phase, and one patient with vomiting during the maintenance phase.

The results of this pilot study need to be confirmed in larger, placebo-controlled, phase II trials that also should identify the optimal dose of omalizumab and subsets of patients with food allergies who might be most likely to benefit from this approach, Dr. Nadeau said. "I don't think this is ready for prime time," she said. "This is a wonderful potential cure for food allergies, but it takes a lot of potential work to get there."

There are no approved treatments for food allergy other than avoiding the offending foods and keeping self-injectable epinephrine handy to treat reactions.

This study appears to be the first to combine omalizumab with oral desensitization for food allergy. Previous studies of oral desensitization regimens have reported success rates of 37%-47%, she said.   

SAN FRANCISCO - Off-label pretreatment with the biologic drug omalizumab enabled relatively rapid oral desensitization to milk allergy in a pilot study of 11 children.

One patient who dropped out of the study after 1 day of desensitization was later diagnosed as having abdominal migraines. Among the remaining 10 patients, 9 tolerated desensitization to a dose of 2,000 mg/day of powdered milk within 7-10 weeks. These nine children then passed a double-blind, placebo-controlled food challenge at weeks 24-27 and have since been consuming 8-12 ounces of milk in their daily diets at home, Dr. Kari C. Nadeau said at the meeting.

Responses to desensitization were seen within 7-11 weeks, compared with 15-16 weeks in previous studies of protocols for oral desensitization to food allergy, reported Dr. Nadeau of Stanford (Calif.) University, and her associates.

The study recruited patients at Stanford and at Children's Hospital, Boston, who had a history of acute reactions to cooked and uncooked milk, mean wheal sizes of 22 mm after skin testing, mean milk-specific IgE measurements of 98 kU/L, and mean total IgE measurements of 701 kU/L. Patients averaged 10 years in age.

For 9 weeks they took omalizumab (Xolair), an anti-IgE monoclonal antibody drug that is approved to treat patients 12 years or older with moderate-to-severe persistent allergic asthma that is insufficiently controlled by inhaled corticosteroids.

Then, in 1 day they underwent a "rush" desensitization to oral doses of 1,000 mg of milk powder, to a cumulative dose of 2,000 mg. Seven patients passed the 1-day desensitization.

From weeks 9 to 16, they continued on omalizumab and the dose of powdered milk was increased weekly under supervision in the medical centers.

Patients stopped taking omalizumab at week 16 but continued taking a maintenance dose of 2,000 mg/day of powdered milk at home, with regular clinic visits for assessments.

Nine of the remaining 10 patients reached an oral daily dose of 2,000 mg of powdered milk (the primary end point) by week 20, and the 10th patient tolerated a dose of 1,200 mg/day.

Nine patients passed a double-blind, placebo-controlled food challenge to up to 3,000 mg of milk and a cumulative dose of 7,200 mg at weeks 24-27. The day after passing the double-blind food challenge, the nine patients began tolerating 8-12 ounces of milk per day in their diet, including ice cream, pizza, and yogurt, Dr. Nadeau said.

Dr. Dale T. Umetsu of Harvard Medical School, Boston, who was the principal investigator in the study, said in an interview that the combination of omalizumab and oral desensitization "allowed us to move relatively quickly in increasing the dose of milk from a very small dose to a very large maintenance dose of milk."

At some point during the study, each of the 11 patients developed a reaction to the milk, and most had 10-11 reactions over the course of the study. Patients have been followed for up to 52 weeks.

The children received a mean of 209 milk doses each. Among the 2,301 total doses, 41 (2%) generated reactions, most of which were mild. Epinephrine was administered for three of the reactions. Most reactions consisted of pruritus, urticaria, or abdominal pain, all of which were treatable, Dr. Nadeau said.

Among 29 reactions with mild symptoms, 14 occurred on the rush-desensitization day, 10 occurred during the weekly dose-escalation phase, and 5 happened during the maintenance phase.

Among eight reactions with moderate symptoms, five occurred on the rush desensitization day, one occurred during the weekly dose-escalation phase, and two occurred during the maintenance phase.

The four reactions with severe symptoms included one patient with tongue swelling and another with disseminated urticaria on the rush-desensitization day, one patient with severe abdominal pain during the weekly dose-escalation phase, and one patient with vomiting during the maintenance phase.

The results of this pilot study need to be confirmed in larger, placebo-controlled, phase II trials that also should identify the optimal dose of omalizumab and subsets of patients with food allergies who might be most likely to benefit from this approach, Dr. Nadeau said. "I don't think this is ready for prime time," she said. "This is a wonderful potential cure for food allergies, but it takes a lot of potential work to get there."

There are no approved treatments for food allergy other than avoiding the offending foods and keeping self-injectable epinephrine handy to treat reactions.

This study appears to be the first to combine omalizumab with oral desensitization for food allergy. Previous studies of oral desensitization regimens have reported success rates of 37%-47%, she said.   

SAN FRANCISCO - Off-label pretreatment with the biologic drug omalizumab enabled relatively rapid oral desensitization to milk allergy in a pilot study of 11 children.

One patient who dropped out of the study after 1 day of desensitization was later diagnosed as having abdominal migraines. Among the remaining 10 patients, 9 tolerated desensitization to a dose of 2,000 mg/day of powdered milk within 7-10 weeks. These nine children then passed a double-blind, placebo-controlled food challenge at weeks 24-27 and have since been consuming 8-12 ounces of milk in their daily diets at home, Dr. Kari C. Nadeau said at the meeting.

Responses to desensitization were seen within 7-11 weeks, compared with 15-16 weeks in previous studies of protocols for oral desensitization to food allergy, reported Dr. Nadeau of Stanford (Calif.) University, and her associates.

The study recruited patients at Stanford and at Children's Hospital, Boston, who had a history of acute reactions to cooked and uncooked milk, mean wheal sizes of 22 mm after skin testing, mean milk-specific IgE measurements of 98 kU/L, and mean total IgE measurements of 701 kU/L. Patients averaged 10 years in age.

For 9 weeks they took omalizumab (Xolair), an anti-IgE monoclonal antibody drug that is approved to treat patients 12 years or older with moderate-to-severe persistent allergic asthma that is insufficiently controlled by inhaled corticosteroids.

Then, in 1 day they underwent a "rush" desensitization to oral doses of 1,000 mg of milk powder, to a cumulative dose of 2,000 mg. Seven patients passed the 1-day desensitization.

From weeks 9 to 16, they continued on omalizumab and the dose of powdered milk was increased weekly under supervision in the medical centers.

Patients stopped taking omalizumab at week 16 but continued taking a maintenance dose of 2,000 mg/day of powdered milk at home, with regular clinic visits for assessments.

Nine of the remaining 10 patients reached an oral daily dose of 2,000 mg of powdered milk (the primary end point) by week 20, and the 10th patient tolerated a dose of 1,200 mg/day.

Nine patients passed a double-blind, placebo-controlled food challenge to up to 3,000 mg of milk and a cumulative dose of 7,200 mg at weeks 24-27. The day after passing the double-blind food challenge, the nine patients began tolerating 8-12 ounces of milk per day in their diet, including ice cream, pizza, and yogurt, Dr. Nadeau said.

Dr. Dale T. Umetsu of Harvard Medical School, Boston, who was the principal investigator in the study, said in an interview that the combination of omalizumab and oral desensitization "allowed us to move relatively quickly in increasing the dose of milk from a very small dose to a very large maintenance dose of milk."

At some point during the study, each of the 11 patients developed a reaction to the milk, and most had 10-11 reactions over the course of the study. Patients have been followed for up to 52 weeks.

The children received a mean of 209 milk doses each. Among the 2,301 total doses, 41 (2%) generated reactions, most of which were mild. Epinephrine was administered for three of the reactions. Most reactions consisted of pruritus, urticaria, or abdominal pain, all of which were treatable, Dr. Nadeau said.

Among 29 reactions with mild symptoms, 14 occurred on the rush-desensitization day, 10 occurred during the weekly dose-escalation phase, and 5 happened during the maintenance phase.

Among eight reactions with moderate symptoms, five occurred on the rush desensitization day, one occurred during the weekly dose-escalation phase, and two occurred during the maintenance phase.

The four reactions with severe symptoms included one patient with tongue swelling and another with disseminated urticaria on the rush-desensitization day, one patient with severe abdominal pain during the weekly dose-escalation phase, and one patient with vomiting during the maintenance phase.

The results of this pilot study need to be confirmed in larger, placebo-controlled, phase II trials that also should identify the optimal dose of omalizumab and subsets of patients with food allergies who might be most likely to benefit from this approach, Dr. Nadeau said. "I don't think this is ready for prime time," she said. "This is a wonderful potential cure for food allergies, but it takes a lot of potential work to get there."

There are no approved treatments for food allergy other than avoiding the offending foods and keeping self-injectable epinephrine handy to treat reactions.

This study appears to be the first to combine omalizumab with oral desensitization for food allergy. Previous studies of oral desensitization regimens have reported success rates of 37%-47%, she said.   

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.

LAS VEGAS – The use of Mohs surgery in Medicare beneficiaries increased steeply in the past decade, mainly for nonmelanoma skin cancers on the face and with great variation in treatment practices, two new studies show.

The majority of physicians who billed Medicare for Mohs surgeries do relatively few of the procedures per year, raising questions about the optimal volume of Mohs surgeries to ensure good outcomes and cost-effectiveness, one of the studies suggested.

The United States is experiencing an epidemic of nonmelanoma skin cancer, which has grown in numbers from approximately 1 million in 1994 to approximately 4 million per year today, Dr. Matthew Donaldson said at the annual meeting of the American College of Mohs Surgery.

The rate of Mohs surgery per 1,000 Medicare beneficiaries increased by 236% between 1999 and 2009, while excisions and destructions of lesions increased by approximately 20%, said Dr. Donaldson, who is training in Mohs surgery under Dr. Brett Coldiron at the skin cancer center of TriHealth Good Samaritan Hospital, Cincinnati.

He and his associates analyzed the Medicare claims database for 2009 to examine who is doing Mohs surgery, and why. They utilized both the Physician/Supplier Procedure Summary Master File (which contains data on all claims for procedures) and a random sample of 5% of claims called the Medicare Limited Data Set Standard Analytic File.

For CPT code 17311 (Mohs surgery on the head, neck, hands, feet, genitalia, or any location directly involving muscles, cartilage, bone, tendon, major nerves, or vessels), Florida and Arizona had more than twice the rate of claims, compared with the national average of 14 claims per 1,000 Medicare beneficiaries.

For CPT code 17313 (Mohs surgery on the trunk, arms or legs), Florida and Arizona had three times the national average of two claims per 1,000 Medicare beneficiaries.

Only 0.1% of CPT 17311 claims and 0.4% of CPT 17313 claims were for malignant melanoma. Carcinoma in situ made up 1% of CPT 17311 claims and 2% of CPT 17313 claims. The rest were for malignant neoplasms, "predominantly for basal cell and squamous cell" carcinomas, he said.

Of the 1,777 medical providers who billed for Mohs surgery in 2009, 97% were dermatologists, accounting for approximately 18% of all practicing dermatologists in the United States.

Dr. Donaldson and his associates used the data to estimate how many Mohs cases each claimant performed. Approximately 44% of physicians who billed Medicare for Mohs surgery did fewer than 200 cases that year, approximately 35% did 300-1,000 cases, and only 5% did more than 1,000 cases, he predicted.

"A full 27% of surgeons in the country are doing, on average, 47 cases in Medicare" beneficiaries, "and probably 100 cases overall for the entire year," Dr. Donaldson said. "Is that a sufficient number to really maximize" cure rates, cosmetic outcomes, and cost-effectiveness?

The physicians who did large volumes of Mohs surgeries in Medicare beneficiaries were more likely to take additional stages beyond the initial surgery, and were more likely to repair defects themselves, compared with low-volume surgeons, he said.

Dr. Kate V. Viola reported in a separate presentation that a minority of nonmelanoma skin cancers in the Medicare population is treated with Mohs, but the use of Mohs for these cancers is increasing at a much faster rate than the use of excisions.

She and her associates looked at a 5% sample of Medicare claims from 2001-2006 in the SEER (Surveillance, Epidemiology and End Results) database representing 26% of the U.S. population in 16 registries.

Of the 26,931 Medicare beneficiaries who were treated for nonmelanoma skin cancers, 36% were treated with Mohs surgery and 64% were treated with wide local excision or simple excision.

The rate of Mohs surgery for nonmelanoma skin cancer "doubled – yes, doubled – by 2006," increasing from 0.7 per 100 beneficiaries in 2001 to 1.5 per 100 beneficiaries, said Dr. Viola of Albert Einstein College of Medicine, New York. During that period, the rate of excisions for nonmelanoma skin cancers increased only slightly, from 1.8 to 2.1 per 100 beneficiaries.

Mohs surgery was more likely than excisional surgery on the face and less likely elsewhere. Mohs surgery was used to treat 47% of facial lesions and 15% of lesions on the rest of the body, she said.

Patient age, race, and geographic region were significantly associated with the likelihood of Mohs surgery. The use of Mohs for these cancers decreased with patient age (from 41% of patients aged 67-69 years to 34% of patients 85 years or older). Mohs was used in 37% of white patients, 23% of black patients, and 29% of patients of other races.

The SEER data did not include some states such as Florida and New York, but among the regions that were represented, the areas with high densities of Mohs surgeons were likely to have higher rates of Mohs surgery for nonmelanoma skin cancers. These areas included San Jose, San Francisco, and Oakland, Calif.

The opposite, however, was not true. Some areas with low densities of Mohs surgeons still had high rates of Mohs utilization, such as in Los Angeles and Detroit.

"There was wide variation in regional Mohs micrographic surgery utilization and geographical disparity that warrants further investigation," Dr. Viola said.

For instance, the density of Mohs surgeons in the Washington, D.C. area was so high – more than six times greater than the next-highest density – that the D.C. region had to be excluded from the analysis as an outlier, she noted.

Mohs surgeries in the Medicare population account for approximately half of all Mohs surgeries in the United States, Dr. Donaldson said.

Dr. Donaldson and Dr. Viola said they have no relevant conflicts of interest.