Michele G. Sullivan

WASHINGTON — Methicillin-resistant strains of Staphylococcus aureus in both healthy and hospitalized children are increasing throughout the country, accompanied by small, but significant, increases in strains that are resistant to both methicillin and clindamycin, according to researchers at the annual meeting of the Pediatric Academic Societies.

Houston has seen ever-increasing rates of methicillin-resistant S. aureus (MRSA) since February 2000, when one-third of community-acquired S. aureus infections were already positive for MRSA, Sheldon Kaplan, M.D., of Texas Children's Hospital, Houston, told this newspaper.

During his poster presentation, Dr. Kaplan said that by November 2000, that rate had increased to 50% and has continued to increase every year. Recently, MRSA isolates that also are resistant to clindamycin have been identified.

His study tracked community-acquired S. aureus infections among pediatric inpatients and outpatients from August 2001 to July 2004. During the study period, 3,578 isolates were associated with community-acquired infections; 74% were MRSA.

In year 1, 72% of the community-acquired S. aureus isolates were MRSA (551 of 771); in year 2, 74% were MRSA (915 of 1,245); and in year 3, 77% were MRSA (1,193 of 1,562). Community-acquired MRSA (CA-MRSA) isolates increased by 2.2-fold, while the increase in community-acquired methicillin-susceptible S. aureus (CA-MSSA) isolates was 1.7-fold.

Of the CA-MRSA isolates, 2,542 (96%) were recovered from children with skin and soft-tissue infection; 62% of these children were admitted to the hospital. Most of the CA-MSSA isolates (92%) were also recovered from skin and soft-tissue infections, with 53% of these children admitted to the hospital.

Most of the CA-MRSA isolates (95%) and about half of CA-MSSA isolates were also resistant to erythromycin; the levels were steady throughout the study. Clindamycin resistance increased among both CA-MRSA and CA-MSSA, although the rates remained low: 2%–6% for MRSA; 3%–11% for MSSA.

This association appears to contradict the theory that the 7-valent pneumococcal conjugate vaccine is related to the increase in community-acquired S. aureus infections, Dr. Kaplan noted.

Although the Texas increase in CA-MRSA occurred in the same year as the PCV7 was licensed for use in children younger than 24 months, there was no significant increase in CA-MRSA infections in that age group during the 3 years of the study. “Our data would not support the idea that the use of PCV7 is associated with the increasing numbers of S. aureus infections we encountered,” Dr. Kaplan said at the meeting, which was sponsored by the American Pediatric Society, the Society for Pediatric Research, the Ambulatory Pediatric Association, and the American Academy of Pediatrics.

CA-MRSA was largely responsible for a dramatic increase in deep venous thrombosis among children hospitalized at the center, according to a poster presented by Blanca Gonzalez, M.D., also of Texas Children's Hospital.

” From 1999 to 2004, we identified 10 children who presented with or developed a venous thrombophlebitis during their hospitalization with an invasive S. aureus infection; nine of those occurred after 2001.”

Of the 10 cases, she said, 8 were associated with CA-MRSA infections and 2 with CA-MSSA infections. Eight of the isolates were positive for Panton-Valentine leukocidin (PVL), a cytotoxin that causes leukocyte destruction and tissue necrosis, and which is produced by most CA-MRSA strains.

“The current PVL-positive clone circulating in Houston appears to have an enhanced propensity to cause DVT in association with osteomyelitis,” Dr. Gonzalez said.

The children ranged in age from 9 months to 14 years. Although six had central catheterization lines, the youngest child was the only one whose DVT was clearly associated with a catheter. The most common site of thrombosis was the femoral vein (60%), and clots frequently extended into the popliteal veins. All of the patients had osteomyelitis and pyomyositis; in nine children, these infections were located adjacent to the site of the thrombosis.

Four patients had septic pulmonary embolisms and required inferior vena cava (IVC) filters. All the children were treated with anticoagulation therapy with either low-molecular-weight heparin or warfarin. Therapy was maintained for a mean of 3.7 months (2.5–7 months).

The thromboses completely resolved in eight patients by a mean of 10 weeks. One child was lost to follow-up and the last child remains on anticoagulation therapy, she said.

In Nashville, Tenn., nasal carriage rates of MRSA are increasing dramatically, said Clarence Buddy Creech, M.D. His study also identified clindamycin-resistant MRSA.

In 2004, Dr. Creech of Vanderbilt University in Nashville studied nasal carriage rates of S. aureus in 500 healthy children, and then compared the rates with a similar study of 500 other healthy children performed at the center in 2001.

In 2001, the nasal carriage rate of MSSA was 28% and the nasal carriage rate of MRSA was just 0.8%. “We had a small—but important—reservoir of MRSA in our community,” Dr. Creech said.

The 2004 follow-up study revealed a 10-fold increase in MRSA nasal carriage. Of the 500 children swabbed, 46 (9.2%) were colonized with MRSA.

Of the 46 MRSA isolates, 45 were susceptible to rifampin, gentamicin, and trimethoprim-sulfamethoxazole. However, 25 (54%) were resistant to erythromycin and 12 (26%) were resistant to clindamycin.

Of the erythromycin-resistant isolates, eight (32%) showed characteristics of inducible resistance by the disk diffusion test. Only 4 of the 46 isolates (8%) expressed constitutive resistance to clindamycin.

Ten of the 46 isolates (21%) were positive for the cytotoxin PVL.

WASHINGTON — Methicillin-resistant strains of Staphylococcus aureus in both healthy and hospitalized children are increasing throughout the country, accompanied by small, but significant, increases in strains that are resistant to both methicillin and clindamycin, according to researchers at the annual meeting of the Pediatric Academic Societies.

Houston has seen ever-increasing rates of methicillin-resistant S. aureus (MRSA) since February 2000, when one-third of community-acquired S. aureus infections were already positive for MRSA, Sheldon Kaplan, M.D., of Texas Children's Hospital, Houston, told this newspaper.

During his poster presentation, Dr. Kaplan said that by November 2000, that rate had increased to 50% and has continued to increase every year. Recently, MRSA isolates that also are resistant to clindamycin have been identified.

His study tracked community-acquired S. aureus infections among pediatric inpatients and outpatients from August 2001 to July 2004. During the study period, 3,578 isolates were associated with community-acquired infections; 74% were MRSA.

In year 1, 72% of the community-acquired S. aureus isolates were MRSA (551 of 771); in year 2, 74% were MRSA (915 of 1,245); and in year 3, 77% were MRSA (1,193 of 1,562). Community-acquired MRSA (CA-MRSA) isolates increased by 2.2-fold, while the increase in community-acquired methicillin-susceptible S. aureus (CA-MSSA) isolates was 1.7-fold.

Of the CA-MRSA isolates, 2,542 (96%) were recovered from children with skin and soft-tissue infection; 62% of these children were admitted to the hospital. Most of the CA-MSSA isolates (92%) were also recovered from skin and soft-tissue infections, with 53% of these children admitted to the hospital.

Most of the CA-MRSA isolates (95%) and about half of CA-MSSA isolates were also resistant to erythromycin; the levels were steady throughout the study. Clindamycin resistance increased among both CA-MRSA and CA-MSSA, although the rates remained low: 2%–6% for MRSA; 3%–11% for MSSA.

This association appears to contradict the theory that the 7-valent pneumococcal conjugate vaccine is related to the increase in community-acquired S. aureus infections, Dr. Kaplan noted.

Although the Texas increase in CA-MRSA occurred in the same year as the PCV7 was licensed for use in children younger than 24 months, there was no significant increase in CA-MRSA infections in that age group during the 3 years of the study. “Our data would not support the idea that the use of PCV7 is associated with the increasing numbers of S. aureus infections we encountered,” Dr. Kaplan said at the meeting, which was sponsored by the American Pediatric Society, the Society for Pediatric Research, the Ambulatory Pediatric Association, and the American Academy of Pediatrics.

CA-MRSA was largely responsible for a dramatic increase in deep venous thrombosis among children hospitalized at the center, according to a poster presented by Blanca Gonzalez, M.D., also of Texas Children's Hospital.

” From 1999 to 2004, we identified 10 children who presented with or developed a venous thrombophlebitis during their hospitalization with an invasive S. aureus infection; nine of those occurred after 2001.”

Of the 10 cases, she said, 8 were associated with CA-MRSA infections and 2 with CA-MSSA infections. Eight of the isolates were positive for Panton-Valentine leukocidin (PVL), a cytotoxin that causes leukocyte destruction and tissue necrosis, and which is produced by most CA-MRSA strains.

“The current PVL-positive clone circulating in Houston appears to have an enhanced propensity to cause DVT in association with osteomyelitis,” Dr. Gonzalez said.

The children ranged in age from 9 months to 14 years. Although six had central catheterization lines, the youngest child was the only one whose DVT was clearly associated with a catheter. The most common site of thrombosis was the femoral vein (60%), and clots frequently extended into the popliteal veins. All of the patients had osteomyelitis and pyomyositis; in nine children, these infections were located adjacent to the site of the thrombosis.

Four patients had septic pulmonary embolisms and required inferior vena cava (IVC) filters. All the children were treated with anticoagulation therapy with either low-molecular-weight heparin or warfarin. Therapy was maintained for a mean of 3.7 months (2.5–7 months).

The thromboses completely resolved in eight patients by a mean of 10 weeks. One child was lost to follow-up and the last child remains on anticoagulation therapy, she said.

In Nashville, Tenn., nasal carriage rates of MRSA are increasing dramatically, said Clarence Buddy Creech, M.D. His study also identified clindamycin-resistant MRSA.

In 2004, Dr. Creech of Vanderbilt University in Nashville studied nasal carriage rates of S. aureus in 500 healthy children, and then compared the rates with a similar study of 500 other healthy children performed at the center in 2001.

In 2001, the nasal carriage rate of MSSA was 28% and the nasal carriage rate of MRSA was just 0.8%. “We had a small—but important—reservoir of MRSA in our community,” Dr. Creech said.

The 2004 follow-up study revealed a 10-fold increase in MRSA nasal carriage. Of the 500 children swabbed, 46 (9.2%) were colonized with MRSA.

Of the 46 MRSA isolates, 45 were susceptible to rifampin, gentamicin, and trimethoprim-sulfamethoxazole. However, 25 (54%) were resistant to erythromycin and 12 (26%) were resistant to clindamycin.

Of the erythromycin-resistant isolates, eight (32%) showed characteristics of inducible resistance by the disk diffusion test. Only 4 of the 46 isolates (8%) expressed constitutive resistance to clindamycin.

Ten of the 46 isolates (21%) were positive for the cytotoxin PVL.

WASHINGTON — Methicillin-resistant strains of Staphylococcus aureus in both healthy and hospitalized children are increasing throughout the country, accompanied by small, but significant, increases in strains that are resistant to both methicillin and clindamycin, according to researchers at the annual meeting of the Pediatric Academic Societies.

Houston has seen ever-increasing rates of methicillin-resistant S. aureus (MRSA) since February 2000, when one-third of community-acquired S. aureus infections were already positive for MRSA, Sheldon Kaplan, M.D., of Texas Children's Hospital, Houston, told this newspaper.

During his poster presentation, Dr. Kaplan said that by November 2000, that rate had increased to 50% and has continued to increase every year. Recently, MRSA isolates that also are resistant to clindamycin have been identified.

His study tracked community-acquired S. aureus infections among pediatric inpatients and outpatients from August 2001 to July 2004. During the study period, 3,578 isolates were associated with community-acquired infections; 74% were MRSA.

In year 1, 72% of the community-acquired S. aureus isolates were MRSA (551 of 771); in year 2, 74% were MRSA (915 of 1,245); and in year 3, 77% were MRSA (1,193 of 1,562). Community-acquired MRSA (CA-MRSA) isolates increased by 2.2-fold, while the increase in community-acquired methicillin-susceptible S. aureus (CA-MSSA) isolates was 1.7-fold.

Of the CA-MRSA isolates, 2,542 (96%) were recovered from children with skin and soft-tissue infection; 62% of these children were admitted to the hospital. Most of the CA-MSSA isolates (92%) were also recovered from skin and soft-tissue infections, with 53% of these children admitted to the hospital.

Most of the CA-MRSA isolates (95%) and about half of CA-MSSA isolates were also resistant to erythromycin; the levels were steady throughout the study. Clindamycin resistance increased among both CA-MRSA and CA-MSSA, although the rates remained low: 2%–6% for MRSA; 3%–11% for MSSA.

This association appears to contradict the theory that the 7-valent pneumococcal conjugate vaccine is related to the increase in community-acquired S. aureus infections, Dr. Kaplan noted.

Although the Texas increase in CA-MRSA occurred in the same year as the PCV7 was licensed for use in children younger than 24 months, there was no significant increase in CA-MRSA infections in that age group during the 3 years of the study. “Our data would not support the idea that the use of PCV7 is associated with the increasing numbers of S. aureus infections we encountered,” Dr. Kaplan said at the meeting, which was sponsored by the American Pediatric Society, the Society for Pediatric Research, the Ambulatory Pediatric Association, and the American Academy of Pediatrics.

CA-MRSA was largely responsible for a dramatic increase in deep venous thrombosis among children hospitalized at the center, according to a poster presented by Blanca Gonzalez, M.D., also of Texas Children's Hospital.

” From 1999 to 2004, we identified 10 children who presented with or developed a venous thrombophlebitis during their hospitalization with an invasive S. aureus infection; nine of those occurred after 2001.”

Of the 10 cases, she said, 8 were associated with CA-MRSA infections and 2 with CA-MSSA infections. Eight of the isolates were positive for Panton-Valentine leukocidin (PVL), a cytotoxin that causes leukocyte destruction and tissue necrosis, and which is produced by most CA-MRSA strains.

“The current PVL-positive clone circulating in Houston appears to have an enhanced propensity to cause DVT in association with osteomyelitis,” Dr. Gonzalez said.

The children ranged in age from 9 months to 14 years. Although six had central catheterization lines, the youngest child was the only one whose DVT was clearly associated with a catheter. The most common site of thrombosis was the femoral vein (60%), and clots frequently extended into the popliteal veins. All of the patients had osteomyelitis and pyomyositis; in nine children, these infections were located adjacent to the site of the thrombosis.

Four patients had septic pulmonary embolisms and required inferior vena cava (IVC) filters. All the children were treated with anticoagulation therapy with either low-molecular-weight heparin or warfarin. Therapy was maintained for a mean of 3.7 months (2.5–7 months).

The thromboses completely resolved in eight patients by a mean of 10 weeks. One child was lost to follow-up and the last child remains on anticoagulation therapy, she said.

In Nashville, Tenn., nasal carriage rates of MRSA are increasing dramatically, said Clarence Buddy Creech, M.D. His study also identified clindamycin-resistant MRSA.

In 2004, Dr. Creech of Vanderbilt University in Nashville studied nasal carriage rates of S. aureus in 500 healthy children, and then compared the rates with a similar study of 500 other healthy children performed at the center in 2001.

In 2001, the nasal carriage rate of MSSA was 28% and the nasal carriage rate of MRSA was just 0.8%. “We had a small—but important—reservoir of MRSA in our community,” Dr. Creech said.

The 2004 follow-up study revealed a 10-fold increase in MRSA nasal carriage. Of the 500 children swabbed, 46 (9.2%) were colonized with MRSA.

Of the 46 MRSA isolates, 45 were susceptible to rifampin, gentamicin, and trimethoprim-sulfamethoxazole. However, 25 (54%) were resistant to erythromycin and 12 (26%) were resistant to clindamycin.

Of the erythromycin-resistant isolates, eight (32%) showed characteristics of inducible resistance by the disk diffusion test. Only 4 of the 46 isolates (8%) expressed constitutive resistance to clindamycin.

Ten of the 46 isolates (21%) were positive for the cytotoxin PVL.

MIAMI BEACH — Four different interferon-β products and dosing schedules appear equally effective as initial therapy for relapsing/remitting multiple sclerosis, Volker Limmroth, M.D., reported in a poster session at the annual meeting of the American Academy of Neurology.

However, all IFN-β products were significantly less effective when used as follow-up therapy, said Dr. Limmroth, of the University of Essen (Germany), and his colleagues.

“These results suggest that patients do not gain further benefit when switching from one IFN-β product to another,” according to Dr. Limmroth.

Dr. Limmroth presented the results of the global Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study which examined long-term outcomes in more than 7,000 patients from 11 countries who took different IFN-β products and dosing regimens. The study broke results down among those who took IFN-β as initial therapy and those who took it as follow-up therapy.

The patients' mean age was 36 years; about 70% were female. Their mean disease duration was about 5 years. Their mean treatment duration was about 40 months and mean Expanded Disability Status Scale (EDSS) was 2.4–2.9.

The therapies examined were intramuscular IFN-β-1a, 30 mcg once weekly; subcutaneous IFN-β-1b, 8 mIU every other day; subcutaneous IFN-β-1a, 22 mcg three times weekly; and subcutaneous IFN-β-1a, 44 mcg three times weekly. Patients had to have been on at least 2 years' uninterrupted therapy (either initial or follow-up). Overall, there were no significant differences on EDSS between the therapies at 1 or 2 years' follow-up. Some differences emerged, however, when the drugs were stratified as either initial or follow-up therapy.

All drugs were more effective as initial therapy than as follow-up therapy. Intramuscular IFN-β-1a resulted in the highest percentage of progression-free patients at 2 years (66%). For the other therapies, the percentage of progression-free patients was 62.2% for subcutaneous IFN-β-1a 44 mcg; 61% for subcutaneous IFN-β-1a 22 mcg; and 52.7% for IFN-β-1b.

Intramuscular IFN-β-1a also resulted in the highest percentage of relapse-free patients over 2 years (50.2%). The percentages for the other therapies were 42% for IFN-β-1b; 37% for subcutaneous IFN-β-1a 22 mcg; and 33.8% for subcutaneous IFN-β-1a 44 mcg.

There were no significant differences in the drugs' effectiveness when they were used as follow-up therapy.

The percentage of progression-free patients ranged from 51.7% for IFN-β-1b to 62% for subcutaneous IFN-β-1a 44 mcg. The percentage of relapse-free patients over 2 years ranged from 33.8% for subcutaneous IFN-β-1a 44 mcg to 42% for IFN-β-1b.

During the study, 18% (1,309 patients) changed therapy. The most frequent reason was perceived lack of efficacy. Switch rates were intramuscular IFN-β-1a, 45%; IFN-β-1b, 31%; subcutaneous IFN-β-1a 22 mcg, 38%; subcutaneous IFN-β-1a 44 mcg, 40%.

Dr. Limmroth is a paid investigator for Biogen Idec Inc. which sponsored the study.

MIAMI BEACH — Four different interferon-β products and dosing schedules appear equally effective as initial therapy for relapsing/remitting multiple sclerosis, Volker Limmroth, M.D., reported in a poster session at the annual meeting of the American Academy of Neurology.

However, all IFN-β products were significantly less effective when used as follow-up therapy, said Dr. Limmroth, of the University of Essen (Germany), and his colleagues.

“These results suggest that patients do not gain further benefit when switching from one IFN-β product to another,” according to Dr. Limmroth.

Dr. Limmroth presented the results of the global Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study which examined long-term outcomes in more than 7,000 patients from 11 countries who took different IFN-β products and dosing regimens. The study broke results down among those who took IFN-β as initial therapy and those who took it as follow-up therapy.

The patients' mean age was 36 years; about 70% were female. Their mean disease duration was about 5 years. Their mean treatment duration was about 40 months and mean Expanded Disability Status Scale (EDSS) was 2.4–2.9.

The therapies examined were intramuscular IFN-β-1a, 30 mcg once weekly; subcutaneous IFN-β-1b, 8 mIU every other day; subcutaneous IFN-β-1a, 22 mcg three times weekly; and subcutaneous IFN-β-1a, 44 mcg three times weekly. Patients had to have been on at least 2 years' uninterrupted therapy (either initial or follow-up). Overall, there were no significant differences on EDSS between the therapies at 1 or 2 years' follow-up. Some differences emerged, however, when the drugs were stratified as either initial or follow-up therapy.

All drugs were more effective as initial therapy than as follow-up therapy. Intramuscular IFN-β-1a resulted in the highest percentage of progression-free patients at 2 years (66%). For the other therapies, the percentage of progression-free patients was 62.2% for subcutaneous IFN-β-1a 44 mcg; 61% for subcutaneous IFN-β-1a 22 mcg; and 52.7% for IFN-β-1b.

Intramuscular IFN-β-1a also resulted in the highest percentage of relapse-free patients over 2 years (50.2%). The percentages for the other therapies were 42% for IFN-β-1b; 37% for subcutaneous IFN-β-1a 22 mcg; and 33.8% for subcutaneous IFN-β-1a 44 mcg.

There were no significant differences in the drugs' effectiveness when they were used as follow-up therapy.

The percentage of progression-free patients ranged from 51.7% for IFN-β-1b to 62% for subcutaneous IFN-β-1a 44 mcg. The percentage of relapse-free patients over 2 years ranged from 33.8% for subcutaneous IFN-β-1a 44 mcg to 42% for IFN-β-1b.

During the study, 18% (1,309 patients) changed therapy. The most frequent reason was perceived lack of efficacy. Switch rates were intramuscular IFN-β-1a, 45%; IFN-β-1b, 31%; subcutaneous IFN-β-1a 22 mcg, 38%; subcutaneous IFN-β-1a 44 mcg, 40%.

Dr. Limmroth is a paid investigator for Biogen Idec Inc. which sponsored the study.

MIAMI BEACH — Four different interferon-β products and dosing schedules appear equally effective as initial therapy for relapsing/remitting multiple sclerosis, Volker Limmroth, M.D., reported in a poster session at the annual meeting of the American Academy of Neurology.

However, all IFN-β products were significantly less effective when used as follow-up therapy, said Dr. Limmroth, of the University of Essen (Germany), and his colleagues.

“These results suggest that patients do not gain further benefit when switching from one IFN-β product to another,” according to Dr. Limmroth.

Dr. Limmroth presented the results of the global Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study which examined long-term outcomes in more than 7,000 patients from 11 countries who took different IFN-β products and dosing regimens. The study broke results down among those who took IFN-β as initial therapy and those who took it as follow-up therapy.

The patients' mean age was 36 years; about 70% were female. Their mean disease duration was about 5 years. Their mean treatment duration was about 40 months and mean Expanded Disability Status Scale (EDSS) was 2.4–2.9.

The therapies examined were intramuscular IFN-β-1a, 30 mcg once weekly; subcutaneous IFN-β-1b, 8 mIU every other day; subcutaneous IFN-β-1a, 22 mcg three times weekly; and subcutaneous IFN-β-1a, 44 mcg three times weekly. Patients had to have been on at least 2 years' uninterrupted therapy (either initial or follow-up). Overall, there were no significant differences on EDSS between the therapies at 1 or 2 years' follow-up. Some differences emerged, however, when the drugs were stratified as either initial or follow-up therapy.

All drugs were more effective as initial therapy than as follow-up therapy. Intramuscular IFN-β-1a resulted in the highest percentage of progression-free patients at 2 years (66%). For the other therapies, the percentage of progression-free patients was 62.2% for subcutaneous IFN-β-1a 44 mcg; 61% for subcutaneous IFN-β-1a 22 mcg; and 52.7% for IFN-β-1b.

Intramuscular IFN-β-1a also resulted in the highest percentage of relapse-free patients over 2 years (50.2%). The percentages for the other therapies were 42% for IFN-β-1b; 37% for subcutaneous IFN-β-1a 22 mcg; and 33.8% for subcutaneous IFN-β-1a 44 mcg.

There were no significant differences in the drugs' effectiveness when they were used as follow-up therapy.

The percentage of progression-free patients ranged from 51.7% for IFN-β-1b to 62% for subcutaneous IFN-β-1a 44 mcg. The percentage of relapse-free patients over 2 years ranged from 33.8% for subcutaneous IFN-β-1a 44 mcg to 42% for IFN-β-1b.

During the study, 18% (1,309 patients) changed therapy. The most frequent reason was perceived lack of efficacy. Switch rates were intramuscular IFN-β-1a, 45%; IFN-β-1b, 31%; subcutaneous IFN-β-1a 22 mcg, 38%; subcutaneous IFN-β-1a 44 mcg, 40%.

Dr. Limmroth is a paid investigator for Biogen Idec Inc. which sponsored the study.

NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.

“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”

Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.

All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.

At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.

Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.

This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.

Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.

Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).

Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.

The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.

Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.

Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.

All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.

NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.

“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”

Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.

All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.

At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.

Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.

This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.

Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.

Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).

Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.

The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.

Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.

Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.

All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.

NEW ORLEANS — Adalimumab appears to be an extremely effective treatment for both psoriasis and psoriatic arthritis, producing improvements of up to 80% in body surface area affected, Jennifer Cather, M.D., reported in a poster at the annual meeting of the American Academy of Dermatology.

“It is by far one of the best drugs we have tried for our refractory psoriasis patients,” Dr. Cather said in an interview. “We are still waiting for the long-term safety data, though, so we have only used it on patients who didn't respond to other therapies.”

Adalimumab is approved for refractory rheumatoid arthritis and marketed as Humira by Abbott Laboratories. Early trials of the usefulness of the tumor necrosis factor-α blocking agent in psoriasis were promising; several phase III studies are now underway. Dr. Cather of Baylor College of Medicine, Houston, participated in some of these trials, but presented data on her clinic's current experience with adalimumab in 24 psoriasis patients. “None of the people in this study were part of any clinical trials, because we did not want to bias the results by only including responders,” she said.

All patients had either psoriasis or psoriatic arthritis, and all had failed at least one therapy, including cyclosporine, PUVA, methotrexate, alefacept, acitretin, hydroxyurea, sulfasalazine, isotretinoin, narrowband UVB, etanercept, prednisone, bexarotene, and infliximab.

At baseline, every patient underwent testing for HIV virus and hepatitis B and C, and every patient got a tuberculin skin test. Other baseline studies included electrolytes, liver function, and complete blood count.

Twelve patients are on adalimumab monotherapy. Their average age is 44 years, and average body surface area (BSA) at baseline was 25%. Six began monotherapy with 40 mg/wk; one patient decreased dosing to 40 mg every 3 weeks as maintenance therapy. Six patients started with 40 mg every other week; two of them escalated to weekly dosing for optimal disease control and one went to 40 mg every 3 weeks as maintenance therapy.

This group has received adalimumab for an average of 30 weeks (9–48 weeks). Their current average BSA is 7%, a 72% reduction from baseline.

Twelve patients are on adalimumab combination therapy. Their average age is 50 years and average BSA at baseline was 22%.

Concomitant therapies include cyclosporine (6), methotrexate (4), narrowband UVB (10), methotrexate and cyclosporine (1), and acitretin and cyclosporine (1).

Nine patients began combination therapy with 40 mg/week adalimumab. One patient decreased dosing to every other week, and two patients failed to taper to every other week.

The two patients on triple combination therapy successfully transitioned to adalimumab as monotherapy for maintenance. One patient transitioned off cyclosporine to adalimumab as maintenance monotherapy. Three other patients started combination therapy with 40 mg adalimumab every other week; two escalated to weekly dosing for optimal disease control. One patient decreased dosing to every 3 weeks as maintenance therapy.

Combination therapy patients have received adalimumab for an average of 24 weeks (6–81 weeks). Their current average BSA is 3.6%—an 80% reduction from baseline.

Adalimumab appears most effective in patients who have not previously been heavily treated, especially with biologics, Dr. Cather noted.

All tumor necrosis factor-α antagonists are associated with an increased risk of lymphoma. However, Dr. Cather stressed, studies showing that association include a very high proportion of rheumatoid arthritis patients, among whom lymphoma occurs at a rate of up to 24 times that of the background population. Psoriasis patients also have an increased risk of lymphoma, but at a much lower rate—only 2–3 times that of the background population.

WASHINGTON — Children who received a combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type b vaccine experienced fever and injection site reactions at rates similar to, or less than, those seen in children who received the component vaccines, Arnd Herz, M.D., said in a poster presented at the annual meeting of the Pediatric Academic Societies.

Dr. Herz of the Kaiser Permanente Vaccine Study Center, Oakland, Calif., presented the combined results of three U.S. studies and one Canadian study at the meeting sponsored by the American Pediatric Society, the Society for Pediatric Research, Ambulatory Pediatric Association, and the American Academy of Pediatrics. These studies examined safety of the combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae (Hib) type b vaccine (Pentacel) in both the infant series and fourth dose of the toddler series, sponsored by Sanofi Pasteur Inc.

In the infant series, 4,198 infants received the combination vaccine, and 2,486 received control vaccines given separately. In the fourth dose studies, 5,033 children received the combination vaccine, and 1,157 received the control vaccines given separately.

All combination and control vaccines were given along with other recommended childhood vaccines.

The rate of fever was similar between groups in both series. In the infant series, fever occurred in 28% of the combination group and 31% of the control group. In the fourth dose studies, fever occurred in 11% of both groups.

Injection site reactions were similar among groups in both studies. In the infant series, 10% of the combination group experienced mild redness, 5% experienced swelling, and 60% experienced tenderness. Among the control group, 20% experienced redness, 10% experienced swelling, and 78% experienced tenderness.

One infant in the combination group had an immediate reaction of urticaria.

In the fourth dose studies, redness occurred in 20% of both groups. Swelling occurred in 10% of both groups, and tenderness occurred in 50% of the combination group and 60% of the control group.

Crying and fussiness in the 3 days after vaccination were similar in all groups. In the infant series, fussiness occurred in 80% of both groups and crying in 78% of both groups. In the fourth dose studies, crying occurred in 60% of both groups and fussiness in 40% of both groups.

The number of adverse events within 60 days of vaccination was similar between both groups in the infant series: 7.2% of combination group and 9.3% of the control group.

For the fourth dose studies, the rate was 2.4% in both groups

The most common adverse events in the infant series were injection site bruising, pain, and erythema; fever; somnolence; irritability; nonspecific pain; dermatitis; nasal congestion; decreased activity; and cough.

The most common adverse events in the fourth dose studies were nasopharyngitis, injection site bruising and erythema, rhinorrhea, dermatitis, fever, cough, and insomnia.

There were no serious vaccine-related adverse events in any of the studies.

WASHINGTON — Children who received a combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type b vaccine experienced fever and injection site reactions at rates similar to, or less than, those seen in children who received the component vaccines, Arnd Herz, M.D., said in a poster presented at the annual meeting of the Pediatric Academic Societies.

Dr. Herz of the Kaiser Permanente Vaccine Study Center, Oakland, Calif., presented the combined results of three U.S. studies and one Canadian study at the meeting sponsored by the American Pediatric Society, the Society for Pediatric Research, Ambulatory Pediatric Association, and the American Academy of Pediatrics. These studies examined safety of the combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae (Hib) type b vaccine (Pentacel) in both the infant series and fourth dose of the toddler series, sponsored by Sanofi Pasteur Inc.

In the infant series, 4,198 infants received the combination vaccine, and 2,486 received control vaccines given separately. In the fourth dose studies, 5,033 children received the combination vaccine, and 1,157 received the control vaccines given separately.

All combination and control vaccines were given along with other recommended childhood vaccines.

The rate of fever was similar between groups in both series. In the infant series, fever occurred in 28% of the combination group and 31% of the control group. In the fourth dose studies, fever occurred in 11% of both groups.

Injection site reactions were similar among groups in both studies. In the infant series, 10% of the combination group experienced mild redness, 5% experienced swelling, and 60% experienced tenderness. Among the control group, 20% experienced redness, 10% experienced swelling, and 78% experienced tenderness.

One infant in the combination group had an immediate reaction of urticaria.

In the fourth dose studies, redness occurred in 20% of both groups. Swelling occurred in 10% of both groups, and tenderness occurred in 50% of the combination group and 60% of the control group.

Crying and fussiness in the 3 days after vaccination were similar in all groups. In the infant series, fussiness occurred in 80% of both groups and crying in 78% of both groups. In the fourth dose studies, crying occurred in 60% of both groups and fussiness in 40% of both groups.

The number of adverse events within 60 days of vaccination was similar between both groups in the infant series: 7.2% of combination group and 9.3% of the control group.

For the fourth dose studies, the rate was 2.4% in both groups

The most common adverse events in the infant series were injection site bruising, pain, and erythema; fever; somnolence; irritability; nonspecific pain; dermatitis; nasal congestion; decreased activity; and cough.

The most common adverse events in the fourth dose studies were nasopharyngitis, injection site bruising and erythema, rhinorrhea, dermatitis, fever, cough, and insomnia.

There were no serious vaccine-related adverse events in any of the studies.

WASHINGTON — Children who received a combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type b vaccine experienced fever and injection site reactions at rates similar to, or less than, those seen in children who received the component vaccines, Arnd Herz, M.D., said in a poster presented at the annual meeting of the Pediatric Academic Societies.

Dr. Herz of the Kaiser Permanente Vaccine Study Center, Oakland, Calif., presented the combined results of three U.S. studies and one Canadian study at the meeting sponsored by the American Pediatric Society, the Society for Pediatric Research, Ambulatory Pediatric Association, and the American Academy of Pediatrics. These studies examined safety of the combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae (Hib) type b vaccine (Pentacel) in both the infant series and fourth dose of the toddler series, sponsored by Sanofi Pasteur Inc.

In the infant series, 4,198 infants received the combination vaccine, and 2,486 received control vaccines given separately. In the fourth dose studies, 5,033 children received the combination vaccine, and 1,157 received the control vaccines given separately.

All combination and control vaccines were given along with other recommended childhood vaccines.

The rate of fever was similar between groups in both series. In the infant series, fever occurred in 28% of the combination group and 31% of the control group. In the fourth dose studies, fever occurred in 11% of both groups.

Injection site reactions were similar among groups in both studies. In the infant series, 10% of the combination group experienced mild redness, 5% experienced swelling, and 60% experienced tenderness. Among the control group, 20% experienced redness, 10% experienced swelling, and 78% experienced tenderness.

One infant in the combination group had an immediate reaction of urticaria.

In the fourth dose studies, redness occurred in 20% of both groups. Swelling occurred in 10% of both groups, and tenderness occurred in 50% of the combination group and 60% of the control group.

Crying and fussiness in the 3 days after vaccination were similar in all groups. In the infant series, fussiness occurred in 80% of both groups and crying in 78% of both groups. In the fourth dose studies, crying occurred in 60% of both groups and fussiness in 40% of both groups.

The number of adverse events within 60 days of vaccination was similar between both groups in the infant series: 7.2% of combination group and 9.3% of the control group.

For the fourth dose studies, the rate was 2.4% in both groups

The most common adverse events in the infant series were injection site bruising, pain, and erythema; fever; somnolence; irritability; nonspecific pain; dermatitis; nasal congestion; decreased activity; and cough.

The most common adverse events in the fourth dose studies were nasopharyngitis, injection site bruising and erythema, rhinorrhea, dermatitis, fever, cough, and insomnia.

There were no serious vaccine-related adverse events in any of the studies.

MIAMI BEACH — The risk of Alzheimer's disease declines by almost half among postmenopausal nonsmokers who use estrogen therapy, but nearly doubles among those who both smoke and use estrogen therapy, Rosebud O. Roberts, M.B., said in a poster presented at the annual meeting of the American Academy of Neurology.

Dr. Roberts, of the Mayo Clinic, Rochester, Minn., also found that estrogen use at a young age might be a predictor for Alzheimer's in postmenopausal women; in contrast, estrogen therapy later in life appears to be protective. But these conclusions may have more to do with premenopausal estrogen levels than postmenopausal estrogen therapy, she said in an interview.

“What I suspect is that smoking may lead to lower estrogen levels premenopausally, which could lead to brain neurons that are less viable and more likely to die early. Those who initiate therapy earlier probably have less [endogenous] estrogen, and more symptoms, while those who initiate therapy at a later age—because they had fewer symptoms or less severe symptoms—probably had more premenopausal estrogen.” Dr. Roberts and her associates conducted a case-control study of 216 women with natural menopause who developed Alzheimer's disease during 1985–1989. They were compared with 210 cognitively intact controls who had similar ages at menarche and menopause. A similar percentage of women in both groups used estrogen therapy for at least 6 months (11.6% of cases, 14% of controls). Of the 54 women on estrogen, the 25 with Alzheimer's started estrogen therapy earlier than the 29 controls (50 years vs. 53 years), and had a shorter lag time between menopause and the initiation of estrogen therapy (1 year vs. 4 years). Estrogen users had a 20% reduced risk of Alzheimer's disease, but this was not statistically significant.

Smokers and nonsmokers differed significantly in the Alzheimer's risk, depending on their estrogen use. The odds ratio of Alzheimer's was 1.93 in smokers who used estrogen therapy and 0.54 in nonsmokers who used estrogen therapy. More than 3 years of estrogen had a protective effect in nonsmokers, reducing the risk of Alzheimer's by almost 70%.

MIAMI BEACH — The risk of Alzheimer's disease declines by almost half among postmenopausal nonsmokers who use estrogen therapy, but nearly doubles among those who both smoke and use estrogen therapy, Rosebud O. Roberts, M.B., said in a poster presented at the annual meeting of the American Academy of Neurology.

Dr. Roberts, of the Mayo Clinic, Rochester, Minn., also found that estrogen use at a young age might be a predictor for Alzheimer's in postmenopausal women; in contrast, estrogen therapy later in life appears to be protective. But these conclusions may have more to do with premenopausal estrogen levels than postmenopausal estrogen therapy, she said in an interview.

“What I suspect is that smoking may lead to lower estrogen levels premenopausally, which could lead to brain neurons that are less viable and more likely to die early. Those who initiate therapy earlier probably have less [endogenous] estrogen, and more symptoms, while those who initiate therapy at a later age—because they had fewer symptoms or less severe symptoms—probably had more premenopausal estrogen.” Dr. Roberts and her associates conducted a case-control study of 216 women with natural menopause who developed Alzheimer's disease during 1985–1989. They were compared with 210 cognitively intact controls who had similar ages at menarche and menopause. A similar percentage of women in both groups used estrogen therapy for at least 6 months (11.6% of cases, 14% of controls). Of the 54 women on estrogen, the 25 with Alzheimer's started estrogen therapy earlier than the 29 controls (50 years vs. 53 years), and had a shorter lag time between menopause and the initiation of estrogen therapy (1 year vs. 4 years). Estrogen users had a 20% reduced risk of Alzheimer's disease, but this was not statistically significant.

Smokers and nonsmokers differed significantly in the Alzheimer's risk, depending on their estrogen use. The odds ratio of Alzheimer's was 1.93 in smokers who used estrogen therapy and 0.54 in nonsmokers who used estrogen therapy. More than 3 years of estrogen had a protective effect in nonsmokers, reducing the risk of Alzheimer's by almost 70%.

MIAMI BEACH — The risk of Alzheimer's disease declines by almost half among postmenopausal nonsmokers who use estrogen therapy, but nearly doubles among those who both smoke and use estrogen therapy, Rosebud O. Roberts, M.B., said in a poster presented at the annual meeting of the American Academy of Neurology.

Dr. Roberts, of the Mayo Clinic, Rochester, Minn., also found that estrogen use at a young age might be a predictor for Alzheimer's in postmenopausal women; in contrast, estrogen therapy later in life appears to be protective. But these conclusions may have more to do with premenopausal estrogen levels than postmenopausal estrogen therapy, she said in an interview.

“What I suspect is that smoking may lead to lower estrogen levels premenopausally, which could lead to brain neurons that are less viable and more likely to die early. Those who initiate therapy earlier probably have less [endogenous] estrogen, and more symptoms, while those who initiate therapy at a later age—because they had fewer symptoms or less severe symptoms—probably had more premenopausal estrogen.” Dr. Roberts and her associates conducted a case-control study of 216 women with natural menopause who developed Alzheimer's disease during 1985–1989. They were compared with 210 cognitively intact controls who had similar ages at menarche and menopause. A similar percentage of women in both groups used estrogen therapy for at least 6 months (11.6% of cases, 14% of controls). Of the 54 women on estrogen, the 25 with Alzheimer's started estrogen therapy earlier than the 29 controls (50 years vs. 53 years), and had a shorter lag time between menopause and the initiation of estrogen therapy (1 year vs. 4 years). Estrogen users had a 20% reduced risk of Alzheimer's disease, but this was not statistically significant.

Smokers and nonsmokers differed significantly in the Alzheimer's risk, depending on their estrogen use. The odds ratio of Alzheimer's was 1.93 in smokers who used estrogen therapy and 0.54 in nonsmokers who used estrogen therapy. More than 3 years of estrogen had a protective effect in nonsmokers, reducing the risk of Alzheimer's by almost 70%.

A new group skills-training program is exploring the vital role of parents as part of the treatment team for adolescents with eating disorders.

“Most families have neither the skills nor the support to address eating disorders at home,” said Nancy Zucker, Ph.D., director of the eating disorders program at Duke University, Durham, N.C.

“Parents don't have the skills to reinforce behaviors consistently at each and every meal, and they don't have a lot of information, even on parenting in general or a forum to talk about what is happening to them and their children,” she said.

The need for a skills-building program has become even more apparent as reimbursement issues interfere with inpatient treatment for these adolescents. “Parents are now getting their children back at lower and lower weights, and the only validated treatment is renourishment,” she noted. But even after initial treatment, the task of renourishment is not an easy one for families.

Given the number of feedings necessary and the conflict they can arouse, it became increasingly obvious that families needed to be more involved in the child's recovery and “that parents needed a lot more support and guidance than they could get in a 1-hour therapy visit,” Dr. Zucker said.

Three years ago, she began meeting with some of her patients' parents in a structured, weekly group. The format was based on other successful parent-training models, such as those used with attention-deficit hyperactivity disorder, in which skills are taught in an atmosphere of support and accountability.

“We try to engage in a process-focused, rather than outcome-focused approach,” said Dr. Zucker, who directs the group. “It is without bias or judgment. That's the philosophy that underpins everything we do.”

Although there are dozens of support groups for parents whose children have eating disorders, Dr. Zucker's is one of the few with a set agenda of developing specific parenting skills aimed at helping modify eating behavior. “We teach what we call an 'off-the-cuff' approach to managing the behaviors of eating disorders,” she said.

Parents are asked not to enter into conflict with the child regarding eating, she explained: “These disorders are a metaphor for the child's emotional state. When they are at the peak of their anger, they can't hear anything. The parent needs to stay calm. Ninety-nine percent of the time, when they don't engage at the top of that emotional wave, the kids will come down, and the power struggle resolves.”

Parents in the group address three barriers that potentiate mealtime conflict: negative perfectionism, expressed negative emotion, and poor self-efficacy. Parents target negative perfectionism within themselves and learn how to create a home environment that doesn't foster that in them or in their children. They also work diligently on emotional regulation, learning to avoid the negative verbal communication that makes working with their children even more difficult.

Each session includes a three-part homework assignment. “They're assigned an eating disorder behavior to target, an adaptive skill in the child that they work on increasing by modeling a positive coping strategy, and a self-care assignment,” Dr. Zucker said. Parents are expected to present the results of that homework during the next group session, where they receive praise and advice from Dr. Zucker and their peers. Unconditional support is key. “It's a no-criticism environment, because our philosophy is, there are no mistakes.”

The group provides a critical stress-relief valve for parents up against a frightening and frustrating disorder, but the assignments aimed at improving parents' skills and their own sense of self-worth aren't easy, said Patty Hernandez, a group member.

Ms. Hernandez's 15-year-old daughter was diagnosed with anorexia nervosa after her weight dropped from 116 to 82 pounds in a 4-month period. The girl's primary care physician failed to recognize the problem, but her mother knew the signs all too well. “I'm anorexic, so I could see very early what was going on,” she said. “First, I saw her dropping out the after-school snacks that she really loved, and then one day I saw a piece of paper where she'd written, 'Nothing tastes as good as being thin.'”

After an unsuccessful hospitalization in a psychiatric ward and a protracted battle with an insurance company, Ms. Hernandez's daughter entered the Duke eating disorders program, and Ms. Hernandez and her husband entered the parent group. “It has been a savior for us,” she said. “It's so invaluable to listen to other parents every week going through the same thing and realize that you're not the only one, you're not crazy, you're not horrible parents,” she said.

Still, being in the group isn't easy, she said. Her own eating issues “became very loud” when she saw her daughter refusing to eat. “It's incredibly hard to remember that I have to take care of myself by getting my three meals and snacks in every day, in order to set a good example for my child.”

Ms. Hernandez isn't alone in expressing her positive experiences with the group. Dr. Zucker recently presented the results of the first of several studies on the group skills-training model. Fourteen caregivers and 10 adolescents were interviewed before and after the parents' 4 months of group work.

Among the patients, weight concern scores fell from 3.16 to 1.40, shape concern scores fell from 3.48 to 2.03, and restraint scores fell from 2.88 to 1.20. The patients' body mass indexes increased a mean of 2 kg/m

Among the parents, 91% strongly agreed that the group was essential for their children's improvement and 82% strongly agreed that their children would not be doing as well if they had not participated in the group.

Last spring, Dr. Zucker received a $10,000 grant from the National Eating Disorders Association (NEDA) for further research into the group model. Her ongoing studies compare the skills-training model to a parent education-only model, and she is investigating different methods of delivering the group content, perhaps via a Web-based program.

Dr. Zucker is now analyzing preliminary data from these studies, and the results will provide a key insight into the usefulness of her model in other practices, said James Mitchell, M.D., professor and chair of the department of neuroscience at the University of North Dakota and chairman of the NEDA grant awards committee that evaluated Dr. Zucker's program.

Sometimes, he said, group therapy models accomplish wonderful results under the hand of a particularly enthusiastic and inspiring leader, but those results turn out not to be reproducible with a different leader.

“Like everything else, initial results can look very good at the first pass, but sometimes don't stand up under scrutiny,” he said. “She needs to show that her results are due to the model itself and that others can use it just as well. Those questions need to be answered. But it looks like it has a lot of promise.”

The parent group model is just one facet of a comprehensive eating disorders treatment program that could include psychiatrists and other M.Ds., psychologists, dietitians, and exercise physiologists committed to working with both patient and family, Dr. Mitchell noted. “Research shows quite clearly that you have a better success rate if you involve the family of an adolescent. One question, however, is how to involve that family. Should it be included in the treatment as a unit, or should you work with the family separately? Dr. Zucker's program is one that's trying to answer that question.”

Dr. Zucker has applied her model's general tenets to two new pilot eating disorder programs: an intensive weekend parent training group for parents who live out of town and a prevention program aimed at high school freshmen. Presented as part of the school's health curriculum, the program focuses on building good mental health, including healthy attitudes about eating, within the family unit.

“We don't give information about eating disorders,” she said. “The key things we focus on are the importance of quality family interaction during consistent meals, separating the negative aspects of perfectionism from the positive, and taking the shame away from making mistakes. We try to help the kids look at mistakes as growth opportunities, instead.”

And she's not stopping with eating disorders—a group for parents with 8- to 10-year-olds at risk for overweight and obesity is in the works. That program, for which Dr. Zucker is recruiting right now, will be based on a similar parent-training format.

“I have lots of ideas—just not enough time,” she laughed.

A new group skills-training program is exploring the vital role of parents as part of the treatment team for adolescents with eating disorders.

“Most families have neither the skills nor the support to address eating disorders at home,” said Nancy Zucker, Ph.D., director of the eating disorders program at Duke University, Durham, N.C.

“Parents don't have the skills to reinforce behaviors consistently at each and every meal, and they don't have a lot of information, even on parenting in general or a forum to talk about what is happening to them and their children,” she said.

The need for a skills-building program has become even more apparent as reimbursement issues interfere with inpatient treatment for these adolescents. “Parents are now getting their children back at lower and lower weights, and the only validated treatment is renourishment,” she noted. But even after initial treatment, the task of renourishment is not an easy one for families.

Given the number of feedings necessary and the conflict they can arouse, it became increasingly obvious that families needed to be more involved in the child's recovery and “that parents needed a lot more support and guidance than they could get in a 1-hour therapy visit,” Dr. Zucker said.

Three years ago, she began meeting with some of her patients' parents in a structured, weekly group. The format was based on other successful parent-training models, such as those used with attention-deficit hyperactivity disorder, in which skills are taught in an atmosphere of support and accountability.

“We try to engage in a process-focused, rather than outcome-focused approach,” said Dr. Zucker, who directs the group. “It is without bias or judgment. That's the philosophy that underpins everything we do.”

Although there are dozens of support groups for parents whose children have eating disorders, Dr. Zucker's is one of the few with a set agenda of developing specific parenting skills aimed at helping modify eating behavior. “We teach what we call an 'off-the-cuff' approach to managing the behaviors of eating disorders,” she said.

Parents are asked not to enter into conflict with the child regarding eating, she explained: “These disorders are a metaphor for the child's emotional state. When they are at the peak of their anger, they can't hear anything. The parent needs to stay calm. Ninety-nine percent of the time, when they don't engage at the top of that emotional wave, the kids will come down, and the power struggle resolves.”

Parents in the group address three barriers that potentiate mealtime conflict: negative perfectionism, expressed negative emotion, and poor self-efficacy. Parents target negative perfectionism within themselves and learn how to create a home environment that doesn't foster that in them or in their children. They also work diligently on emotional regulation, learning to avoid the negative verbal communication that makes working with their children even more difficult.

Each session includes a three-part homework assignment. “They're assigned an eating disorder behavior to target, an adaptive skill in the child that they work on increasing by modeling a positive coping strategy, and a self-care assignment,” Dr. Zucker said. Parents are expected to present the results of that homework during the next group session, where they receive praise and advice from Dr. Zucker and their peers. Unconditional support is key. “It's a no-criticism environment, because our philosophy is, there are no mistakes.”

The group provides a critical stress-relief valve for parents up against a frightening and frustrating disorder, but the assignments aimed at improving parents' skills and their own sense of self-worth aren't easy, said Patty Hernandez, a group member.

Ms. Hernandez's 15-year-old daughter was diagnosed with anorexia nervosa after her weight dropped from 116 to 82 pounds in a 4-month period. The girl's primary care physician failed to recognize the problem, but her mother knew the signs all too well. “I'm anorexic, so I could see very early what was going on,” she said. “First, I saw her dropping out the after-school snacks that she really loved, and then one day I saw a piece of paper where she'd written, 'Nothing tastes as good as being thin.'”

After an unsuccessful hospitalization in a psychiatric ward and a protracted battle with an insurance company, Ms. Hernandez's daughter entered the Duke eating disorders program, and Ms. Hernandez and her husband entered the parent group. “It has been a savior for us,” she said. “It's so invaluable to listen to other parents every week going through the same thing and realize that you're not the only one, you're not crazy, you're not horrible parents,” she said.

Still, being in the group isn't easy, she said. Her own eating issues “became very loud” when she saw her daughter refusing to eat. “It's incredibly hard to remember that I have to take care of myself by getting my three meals and snacks in every day, in order to set a good example for my child.”

Ms. Hernandez isn't alone in expressing her positive experiences with the group. Dr. Zucker recently presented the results of the first of several studies on the group skills-training model. Fourteen caregivers and 10 adolescents were interviewed before and after the parents' 4 months of group work.

Among the patients, weight concern scores fell from 3.16 to 1.40, shape concern scores fell from 3.48 to 2.03, and restraint scores fell from 2.88 to 1.20. The patients' body mass indexes increased a mean of 2 kg/m

Among the parents, 91% strongly agreed that the group was essential for their children's improvement and 82% strongly agreed that their children would not be doing as well if they had not participated in the group.

Last spring, Dr. Zucker received a $10,000 grant from the National Eating Disorders Association (NEDA) for further research into the group model. Her ongoing studies compare the skills-training model to a parent education-only model, and she is investigating different methods of delivering the group content, perhaps via a Web-based program.

Dr. Zucker is now analyzing preliminary data from these studies, and the results will provide a key insight into the usefulness of her model in other practices, said James Mitchell, M.D., professor and chair of the department of neuroscience at the University of North Dakota and chairman of the NEDA grant awards committee that evaluated Dr. Zucker's program.

Sometimes, he said, group therapy models accomplish wonderful results under the hand of a particularly enthusiastic and inspiring leader, but those results turn out not to be reproducible with a different leader.

“Like everything else, initial results can look very good at the first pass, but sometimes don't stand up under scrutiny,” he said. “She needs to show that her results are due to the model itself and that others can use it just as well. Those questions need to be answered. But it looks like it has a lot of promise.”

The parent group model is just one facet of a comprehensive eating disorders treatment program that could include psychiatrists and other M.Ds., psychologists, dietitians, and exercise physiologists committed to working with both patient and family, Dr. Mitchell noted. “Research shows quite clearly that you have a better success rate if you involve the family of an adolescent. One question, however, is how to involve that family. Should it be included in the treatment as a unit, or should you work with the family separately? Dr. Zucker's program is one that's trying to answer that question.”

Dr. Zucker has applied her model's general tenets to two new pilot eating disorder programs: an intensive weekend parent training group for parents who live out of town and a prevention program aimed at high school freshmen. Presented as part of the school's health curriculum, the program focuses on building good mental health, including healthy attitudes about eating, within the family unit.

“We don't give information about eating disorders,” she said. “The key things we focus on are the importance of quality family interaction during consistent meals, separating the negative aspects of perfectionism from the positive, and taking the shame away from making mistakes. We try to help the kids look at mistakes as growth opportunities, instead.”

And she's not stopping with eating disorders—a group for parents with 8- to 10-year-olds at risk for overweight and obesity is in the works. That program, for which Dr. Zucker is recruiting right now, will be based on a similar parent-training format.

“I have lots of ideas—just not enough time,” she laughed.

A new group skills-training program is exploring the vital role of parents as part of the treatment team for adolescents with eating disorders.

“Most families have neither the skills nor the support to address eating disorders at home,” said Nancy Zucker, Ph.D., director of the eating disorders program at Duke University, Durham, N.C.

“Parents don't have the skills to reinforce behaviors consistently at each and every meal, and they don't have a lot of information, even on parenting in general or a forum to talk about what is happening to them and their children,” she said.

The need for a skills-building program has become even more apparent as reimbursement issues interfere with inpatient treatment for these adolescents. “Parents are now getting their children back at lower and lower weights, and the only validated treatment is renourishment,” she noted. But even after initial treatment, the task of renourishment is not an easy one for families.

Given the number of feedings necessary and the conflict they can arouse, it became increasingly obvious that families needed to be more involved in the child's recovery and “that parents needed a lot more support and guidance than they could get in a 1-hour therapy visit,” Dr. Zucker said.

Three years ago, she began meeting with some of her patients' parents in a structured, weekly group. The format was based on other successful parent-training models, such as those used with attention-deficit hyperactivity disorder, in which skills are taught in an atmosphere of support and accountability.

“We try to engage in a process-focused, rather than outcome-focused approach,” said Dr. Zucker, who directs the group. “It is without bias or judgment. That's the philosophy that underpins everything we do.”

Although there are dozens of support groups for parents whose children have eating disorders, Dr. Zucker's is one of the few with a set agenda of developing specific parenting skills aimed at helping modify eating behavior. “We teach what we call an 'off-the-cuff' approach to managing the behaviors of eating disorders,” she said.

Parents are asked not to enter into conflict with the child regarding eating, she explained: “These disorders are a metaphor for the child's emotional state. When they are at the peak of their anger, they can't hear anything. The parent needs to stay calm. Ninety-nine percent of the time, when they don't engage at the top of that emotional wave, the kids will come down, and the power struggle resolves.”

Parents in the group address three barriers that potentiate mealtime conflict: negative perfectionism, expressed negative emotion, and poor self-efficacy. Parents target negative perfectionism within themselves and learn how to create a home environment that doesn't foster that in them or in their children. They also work diligently on emotional regulation, learning to avoid the negative verbal communication that makes working with their children even more difficult.

Each session includes a three-part homework assignment. “They're assigned an eating disorder behavior to target, an adaptive skill in the child that they work on increasing by modeling a positive coping strategy, and a self-care assignment,” Dr. Zucker said. Parents are expected to present the results of that homework during the next group session, where they receive praise and advice from Dr. Zucker and their peers. Unconditional support is key. “It's a no-criticism environment, because our philosophy is, there are no mistakes.”

The group provides a critical stress-relief valve for parents up against a frightening and frustrating disorder, but the assignments aimed at improving parents' skills and their own sense of self-worth aren't easy, said Patty Hernandez, a group member.

Ms. Hernandez's 15-year-old daughter was diagnosed with anorexia nervosa after her weight dropped from 116 to 82 pounds in a 4-month period. The girl's primary care physician failed to recognize the problem, but her mother knew the signs all too well. “I'm anorexic, so I could see very early what was going on,” she said. “First, I saw her dropping out the after-school snacks that she really loved, and then one day I saw a piece of paper where she'd written, 'Nothing tastes as good as being thin.'”

After an unsuccessful hospitalization in a psychiatric ward and a protracted battle with an insurance company, Ms. Hernandez's daughter entered the Duke eating disorders program, and Ms. Hernandez and her husband entered the parent group. “It has been a savior for us,” she said. “It's so invaluable to listen to other parents every week going through the same thing and realize that you're not the only one, you're not crazy, you're not horrible parents,” she said.

Still, being in the group isn't easy, she said. Her own eating issues “became very loud” when she saw her daughter refusing to eat. “It's incredibly hard to remember that I have to take care of myself by getting my three meals and snacks in every day, in order to set a good example for my child.”

Ms. Hernandez isn't alone in expressing her positive experiences with the group. Dr. Zucker recently presented the results of the first of several studies on the group skills-training model. Fourteen caregivers and 10 adolescents were interviewed before and after the parents' 4 months of group work.

Among the patients, weight concern scores fell from 3.16 to 1.40, shape concern scores fell from 3.48 to 2.03, and restraint scores fell from 2.88 to 1.20. The patients' body mass indexes increased a mean of 2 kg/m

Among the parents, 91% strongly agreed that the group was essential for their children's improvement and 82% strongly agreed that their children would not be doing as well if they had not participated in the group.

Last spring, Dr. Zucker received a $10,000 grant from the National Eating Disorders Association (NEDA) for further research into the group model. Her ongoing studies compare the skills-training model to a parent education-only model, and she is investigating different methods of delivering the group content, perhaps via a Web-based program.

Dr. Zucker is now analyzing preliminary data from these studies, and the results will provide a key insight into the usefulness of her model in other practices, said James Mitchell, M.D., professor and chair of the department of neuroscience at the University of North Dakota and chairman of the NEDA grant awards committee that evaluated Dr. Zucker's program.

Sometimes, he said, group therapy models accomplish wonderful results under the hand of a particularly enthusiastic and inspiring leader, but those results turn out not to be reproducible with a different leader.

“Like everything else, initial results can look very good at the first pass, but sometimes don't stand up under scrutiny,” he said. “She needs to show that her results are due to the model itself and that others can use it just as well. Those questions need to be answered. But it looks like it has a lot of promise.”

The parent group model is just one facet of a comprehensive eating disorders treatment program that could include psychiatrists and other M.Ds., psychologists, dietitians, and exercise physiologists committed to working with both patient and family, Dr. Mitchell noted. “Research shows quite clearly that you have a better success rate if you involve the family of an adolescent. One question, however, is how to involve that family. Should it be included in the treatment as a unit, or should you work with the family separately? Dr. Zucker's program is one that's trying to answer that question.”

Dr. Zucker has applied her model's general tenets to two new pilot eating disorder programs: an intensive weekend parent training group for parents who live out of town and a prevention program aimed at high school freshmen. Presented as part of the school's health curriculum, the program focuses on building good mental health, including healthy attitudes about eating, within the family unit.

“We don't give information about eating disorders,” she said. “The key things we focus on are the importance of quality family interaction during consistent meals, separating the negative aspects of perfectionism from the positive, and taking the shame away from making mistakes. We try to help the kids look at mistakes as growth opportunities, instead.”

And she's not stopping with eating disorders—a group for parents with 8- to 10-year-olds at risk for overweight and obesity is in the works. That program, for which Dr. Zucker is recruiting right now, will be based on a similar parent-training format.

“I have lots of ideas—just not enough time,” she laughed.

NEW ORLEANS — Sunless tanning preparations are linked with a decrease in the use of tanning beds and a slight increase in the use of sunscreens, Daniel Sheehan, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

Although Dr. Sheehan's survey of 121 people who used such a product indicated that most didn't change their outdoor sun exposure, the reported decrease in tanning bed exposure could have a positive effect on skin health.

“Traditional ultraviolet light tanning bed use has been linked to melanoma and nonmelanoma skin cancers by recent case-control studies,” commented Dr. Sheehan in an interview.

He also said, given this prevalence, physicians “should advocate the use of sunless tanning to their patients and their community as a means of decreasing traditional [ultraviolet light] tanning bed use and UVL exposure.”

Dr. Sheehan, of the Medical College of Georgia, Augusta, administered surveys to 121 sunless tanning patrons at two salons.

The subjects ranged in age from 14 to 58 years. The survey group was composed of 78 first-time users and 43 repeat users.

About one-quarter of patrons (26%) said sunless tanning decreased their outdoor sun exposure, but most (64%) said it had no effect. Almost one-quarter (23%) said sunless tanning increased their use of sunscreen.

The largest effect was seen in decreased use of tanning beds; 70% said sunless tanning decreased their use of tanning beds.

The trend toward decreased outdoor sun exposure and increased sunscreen use may represent additional health benefits of sunless tanning, in addition to the statistically significant decrease in tanning bed use, Dr. Sheehan noted.

The spray-on tanning offered at the salon isn't cheap: It's at least $20 per session, he said. But there are many over-the-counter preparations that offer similar results at a lower cost.

It's important to remember, however, that patients counseled to use those products should also be counseled to use sunscreen, he added.

NEW ORLEANS — Sunless tanning preparations are linked with a decrease in the use of tanning beds and a slight increase in the use of sunscreens, Daniel Sheehan, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

Although Dr. Sheehan's survey of 121 people who used such a product indicated that most didn't change their outdoor sun exposure, the reported decrease in tanning bed exposure could have a positive effect on skin health.

“Traditional ultraviolet light tanning bed use has been linked to melanoma and nonmelanoma skin cancers by recent case-control studies,” commented Dr. Sheehan in an interview.

He also said, given this prevalence, physicians “should advocate the use of sunless tanning to their patients and their community as a means of decreasing traditional [ultraviolet light] tanning bed use and UVL exposure.”

Dr. Sheehan, of the Medical College of Georgia, Augusta, administered surveys to 121 sunless tanning patrons at two salons.

The subjects ranged in age from 14 to 58 years. The survey group was composed of 78 first-time users and 43 repeat users.

About one-quarter of patrons (26%) said sunless tanning decreased their outdoor sun exposure, but most (64%) said it had no effect. Almost one-quarter (23%) said sunless tanning increased their use of sunscreen.

The largest effect was seen in decreased use of tanning beds; 70% said sunless tanning decreased their use of tanning beds.

The trend toward decreased outdoor sun exposure and increased sunscreen use may represent additional health benefits of sunless tanning, in addition to the statistically significant decrease in tanning bed use, Dr. Sheehan noted.

The spray-on tanning offered at the salon isn't cheap: It's at least $20 per session, he said. But there are many over-the-counter preparations that offer similar results at a lower cost.

It's important to remember, however, that patients counseled to use those products should also be counseled to use sunscreen, he added.

NEW ORLEANS — Sunless tanning preparations are linked with a decrease in the use of tanning beds and a slight increase in the use of sunscreens, Daniel Sheehan, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

Although Dr. Sheehan's survey of 121 people who used such a product indicated that most didn't change their outdoor sun exposure, the reported decrease in tanning bed exposure could have a positive effect on skin health.

“Traditional ultraviolet light tanning bed use has been linked to melanoma and nonmelanoma skin cancers by recent case-control studies,” commented Dr. Sheehan in an interview.

He also said, given this prevalence, physicians “should advocate the use of sunless tanning to their patients and their community as a means of decreasing traditional [ultraviolet light] tanning bed use and UVL exposure.”

Dr. Sheehan, of the Medical College of Georgia, Augusta, administered surveys to 121 sunless tanning patrons at two salons.

The subjects ranged in age from 14 to 58 years. The survey group was composed of 78 first-time users and 43 repeat users.

About one-quarter of patrons (26%) said sunless tanning decreased their outdoor sun exposure, but most (64%) said it had no effect. Almost one-quarter (23%) said sunless tanning increased their use of sunscreen.

The largest effect was seen in decreased use of tanning beds; 70% said sunless tanning decreased their use of tanning beds.

The trend toward decreased outdoor sun exposure and increased sunscreen use may represent additional health benefits of sunless tanning, in addition to the statistically significant decrease in tanning bed use, Dr. Sheehan noted.

The spray-on tanning offered at the salon isn't cheap: It's at least $20 per session, he said. But there are many over-the-counter preparations that offer similar results at a lower cost.

It's important to remember, however, that patients counseled to use those products should also be counseled to use sunscreen, he added.

ST. LOUIS — An investigational ointment containing extract of green tea successfully clears genital warts in about 60% of patients, Karl Beutner, M.D., said at the annual meeting of the Society for Investigative Dermatology.

The ointment, polyphenon E, is being developed by MediGene AG, Martinsried, Germany. The active ingredient is 80% tea polyphenols.

The main catechin in the extract is (-)-epigallocatechin gallate (EGCG), which has been shown to induce apoptosis in human carcinoma cell lines.

“It's a strong antioxidant that inhibits a number of different enzymes,” said Dr. Beutner, chief medical officer at Dow Pharmaceutical Sciences, Petaluma, Calif., and associate clinical professor of dermatology at the University of California, San Francisco. “Unpublished reports indicate that it induces a pro-Th1 cytokine profile not dissimilar to that of imiquimod.”

The three-armed, placebo-controlled trial randomized 502 patients to either an active ointment of 10% or 15% concentration, or the vehicle, which contains isopropyl myristate. Patients had an average of eight anogenital warts (2–30), which covered an average area of 95 mm

Patients applied the ointment three times a day for up to 16 weeks, or until clearance of all warts. Those who cleared completely were enrolled in a 12-week follow-up trial to assess recurrence rates.

“The primary end point was clearance of all warts—the baseline warts and any warts that developed during treatment,” Dr. Beutner said. “This is an important distinction because other trials report the response in terms of only clearing the baseline warts. This was a stringent end point. They had to be clear of all warts,” he said.

At the end 16 weeks of treatment, about 59% of patients in both active groups had complete clearance of their baseline warts, compared with about 34% of vehicle patients. Complete clearance of all warts occurred in 56% of the 10% group, 57% of the 15% group, and almost 34% of the vehicle group. Average time to response was 11 weeks.

About 80% of those in both active groups had more than 50% clearance. Less than 10% of those in either active group failed to respond. Women responded better than men, with about 65% of women and 50% of men in both active groups achieving complete clearance.

During the 12-week follow-up period, 8.8% of those in the vehicle group experienced recurrence of baseline warts, compared with 6.5% of the group receiving the 15% formulation and 8.3% of the group receiving the 10% formulation. No new warts appeared in the vehicle group; however, new warts did appear in 8% of the group receiving the 10% formulation and in 3.7% of the group receiving the 15% formulation.

About 87% of the active patients and 72% of the vehicle patients experienced at least one adverse event; events peaked at 2 weeks and then declined throughout the trial. Most were mild to moderate and included erythema, erosion, excoriation/flaking, edema, and induration. Only 1% of the patients discontinued use because of an adverse event. About 20% of the vehicle patients also experienced a mild to moderate local reaction.

The only serious adverse events related to the study drug were two cases of vulvovaginitis, which were judged to be application site reactions. Clinical trials for the ointment have been completed for the genital warts indication, Dr. Beutner said. MediGene AG also is conducting a phase II trial of the ointment for the treatment of actinic keratosis. Dr. Beutner is a consultant for the company.

ST. LOUIS — An investigational ointment containing extract of green tea successfully clears genital warts in about 60% of patients, Karl Beutner, M.D., said at the annual meeting of the Society for Investigative Dermatology.

The ointment, polyphenon E, is being developed by MediGene AG, Martinsried, Germany. The active ingredient is 80% tea polyphenols.

The main catechin in the extract is (-)-epigallocatechin gallate (EGCG), which has been shown to induce apoptosis in human carcinoma cell lines.

“It's a strong antioxidant that inhibits a number of different enzymes,” said Dr. Beutner, chief medical officer at Dow Pharmaceutical Sciences, Petaluma, Calif., and associate clinical professor of dermatology at the University of California, San Francisco. “Unpublished reports indicate that it induces a pro-Th1 cytokine profile not dissimilar to that of imiquimod.”

The three-armed, placebo-controlled trial randomized 502 patients to either an active ointment of 10% or 15% concentration, or the vehicle, which contains isopropyl myristate. Patients had an average of eight anogenital warts (2–30), which covered an average area of 95 mm

Patients applied the ointment three times a day for up to 16 weeks, or until clearance of all warts. Those who cleared completely were enrolled in a 12-week follow-up trial to assess recurrence rates.

“The primary end point was clearance of all warts—the baseline warts and any warts that developed during treatment,” Dr. Beutner said. “This is an important distinction because other trials report the response in terms of only clearing the baseline warts. This was a stringent end point. They had to be clear of all warts,” he said.

At the end 16 weeks of treatment, about 59% of patients in both active groups had complete clearance of their baseline warts, compared with about 34% of vehicle patients. Complete clearance of all warts occurred in 56% of the 10% group, 57% of the 15% group, and almost 34% of the vehicle group. Average time to response was 11 weeks.

About 80% of those in both active groups had more than 50% clearance. Less than 10% of those in either active group failed to respond. Women responded better than men, with about 65% of women and 50% of men in both active groups achieving complete clearance.

During the 12-week follow-up period, 8.8% of those in the vehicle group experienced recurrence of baseline warts, compared with 6.5% of the group receiving the 15% formulation and 8.3% of the group receiving the 10% formulation. No new warts appeared in the vehicle group; however, new warts did appear in 8% of the group receiving the 10% formulation and in 3.7% of the group receiving the 15% formulation.

About 87% of the active patients and 72% of the vehicle patients experienced at least one adverse event; events peaked at 2 weeks and then declined throughout the trial. Most were mild to moderate and included erythema, erosion, excoriation/flaking, edema, and induration. Only 1% of the patients discontinued use because of an adverse event. About 20% of the vehicle patients also experienced a mild to moderate local reaction.

The only serious adverse events related to the study drug were two cases of vulvovaginitis, which were judged to be application site reactions. Clinical trials for the ointment have been completed for the genital warts indication, Dr. Beutner said. MediGene AG also is conducting a phase II trial of the ointment for the treatment of actinic keratosis. Dr. Beutner is a consultant for the company.

ST. LOUIS — An investigational ointment containing extract of green tea successfully clears genital warts in about 60% of patients, Karl Beutner, M.D., said at the annual meeting of the Society for Investigative Dermatology.

The ointment, polyphenon E, is being developed by MediGene AG, Martinsried, Germany. The active ingredient is 80% tea polyphenols.

The main catechin in the extract is (-)-epigallocatechin gallate (EGCG), which has been shown to induce apoptosis in human carcinoma cell lines.

“It's a strong antioxidant that inhibits a number of different enzymes,” said Dr. Beutner, chief medical officer at Dow Pharmaceutical Sciences, Petaluma, Calif., and associate clinical professor of dermatology at the University of California, San Francisco. “Unpublished reports indicate that it induces a pro-Th1 cytokine profile not dissimilar to that of imiquimod.”

The three-armed, placebo-controlled trial randomized 502 patients to either an active ointment of 10% or 15% concentration, or the vehicle, which contains isopropyl myristate. Patients had an average of eight anogenital warts (2–30), which covered an average area of 95 mm

Patients applied the ointment three times a day for up to 16 weeks, or until clearance of all warts. Those who cleared completely were enrolled in a 12-week follow-up trial to assess recurrence rates.

“The primary end point was clearance of all warts—the baseline warts and any warts that developed during treatment,” Dr. Beutner said. “This is an important distinction because other trials report the response in terms of only clearing the baseline warts. This was a stringent end point. They had to be clear of all warts,” he said.

At the end 16 weeks of treatment, about 59% of patients in both active groups had complete clearance of their baseline warts, compared with about 34% of vehicle patients. Complete clearance of all warts occurred in 56% of the 10% group, 57% of the 15% group, and almost 34% of the vehicle group. Average time to response was 11 weeks.

About 80% of those in both active groups had more than 50% clearance. Less than 10% of those in either active group failed to respond. Women responded better than men, with about 65% of women and 50% of men in both active groups achieving complete clearance.

During the 12-week follow-up period, 8.8% of those in the vehicle group experienced recurrence of baseline warts, compared with 6.5% of the group receiving the 15% formulation and 8.3% of the group receiving the 10% formulation. No new warts appeared in the vehicle group; however, new warts did appear in 8% of the group receiving the 10% formulation and in 3.7% of the group receiving the 15% formulation.

About 87% of the active patients and 72% of the vehicle patients experienced at least one adverse event; events peaked at 2 weeks and then declined throughout the trial. Most were mild to moderate and included erythema, erosion, excoriation/flaking, edema, and induration. Only 1% of the patients discontinued use because of an adverse event. About 20% of the vehicle patients also experienced a mild to moderate local reaction.

The only serious adverse events related to the study drug were two cases of vulvovaginitis, which were judged to be application site reactions. Clinical trials for the ointment have been completed for the genital warts indication, Dr. Beutner said. MediGene AG also is conducting a phase II trial of the ointment for the treatment of actinic keratosis. Dr. Beutner is a consultant for the company.

Bacterial vaginosis, high-density group B streptococcus colonization, and the use of hormonal contraceptives are all independently associated with increased risk of genital tract shedding of herpes simplex virus type 2, Thomas L. Cherpes, M.D., and his colleagues at the University of Pittsburgh reported.

These increased risks could be key factors in HSV-2 transmission.

“Because hormonal contraceptives are used by more than 100 million women worldwide, and because bacterial vaginosis and vaginal GBS colonization are two of the most common genital tract conditions present among women of reproductive age, even modest associations between these variables and genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus,” they reported (Clin. Infect. Dis. 2005;40:1422–8).

The researchers followed 330 HSV-2-positive women for a year. The women were aged 18–30 years; 65% were black. Every 4 months, the investigators collected behavioral data, vaginal swabs and smears, and a blood sample from each woman.

In the multivariate analysis, genital tract shedding was associated with recent HSV-2 seroconversion (odds ratio [OR] of 3), high-density group B streptococcus colonization (OR 2.2), bacterial vaginosis (OR 1.9), and the use of either depomedroxyprogesterone acetate or oral contraceptives (OR 1.8).

Genital tract shedding was not associated with vaginal intercourse, having a new sex partner, or douching.

The associations with bacterial vaginosis and high-density GBS colonization were somewhat of a surprise, the researchers said. “A number of recent studies have demonstrated that [bacterial vaginosis] is associated with significant alterations in the concentrations of several immunomodulatory cytokines, compared with the concentrations of these cytokines associated with normal vaginal flora.”

Oral contraceptives may influence shedding by different means, the researchers said. Suppression of estrogen and progesterone may alter the T cell-mediated immune response, and thereby increase shedding.

Additionally, women who use oral contraceptives can have larger areas of cervical ectopy. “This extension of the single-layered columnar epithelium onto the ectocervix may facilitate genital tract shedding.”

However, since the increased risk was the same for both oral and injectable hormonal contraceptives, and cervical ectopy is more commonly associated with the oral form, it may not be the predominate mechanism responsible for increased viral shedding, they said.

Previous studies on the subject have reached varying conclusions, Katherine LaGuardia, M.D., medical affairs director for Ortho Women's Health, Ortho-McNeil Pharmaceutical, Inc., said in an interview.

“This study really doesn't shed any new light on this issue,” she said. “The definitive study, which would control for both sexual behavior and hormonal contraception, has yet to be done.”

However, it's important to continue emphasizing to women that no hormonal contraceptive method protects against sexually transmitted infection, Dr. LaGuardia said.

“Although safe and effective when used as labeled, these methods don't protect against infection,” she added. “Using a condom along with hormonal methods offers the best protection against both pregnancy and STIs, including HIV,” Dr. LaGuardia explained.

Bacterial vaginosis, high-density group B streptococcus colonization, and the use of hormonal contraceptives are all independently associated with increased risk of genital tract shedding of herpes simplex virus type 2, Thomas L. Cherpes, M.D., and his colleagues at the University of Pittsburgh reported.

These increased risks could be key factors in HSV-2 transmission.

“Because hormonal contraceptives are used by more than 100 million women worldwide, and because bacterial vaginosis and vaginal GBS colonization are two of the most common genital tract conditions present among women of reproductive age, even modest associations between these variables and genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus,” they reported (Clin. Infect. Dis. 2005;40:1422–8).

The researchers followed 330 HSV-2-positive women for a year. The women were aged 18–30 years; 65% were black. Every 4 months, the investigators collected behavioral data, vaginal swabs and smears, and a blood sample from each woman.

In the multivariate analysis, genital tract shedding was associated with recent HSV-2 seroconversion (odds ratio [OR] of 3), high-density group B streptococcus colonization (OR 2.2), bacterial vaginosis (OR 1.9), and the use of either depomedroxyprogesterone acetate or oral contraceptives (OR 1.8).

Genital tract shedding was not associated with vaginal intercourse, having a new sex partner, or douching.

The associations with bacterial vaginosis and high-density GBS colonization were somewhat of a surprise, the researchers said. “A number of recent studies have demonstrated that [bacterial vaginosis] is associated with significant alterations in the concentrations of several immunomodulatory cytokines, compared with the concentrations of these cytokines associated with normal vaginal flora.”

Oral contraceptives may influence shedding by different means, the researchers said. Suppression of estrogen and progesterone may alter the T cell-mediated immune response, and thereby increase shedding.

Additionally, women who use oral contraceptives can have larger areas of cervical ectopy. “This extension of the single-layered columnar epithelium onto the ectocervix may facilitate genital tract shedding.”

However, since the increased risk was the same for both oral and injectable hormonal contraceptives, and cervical ectopy is more commonly associated with the oral form, it may not be the predominate mechanism responsible for increased viral shedding, they said.

Previous studies on the subject have reached varying conclusions, Katherine LaGuardia, M.D., medical affairs director for Ortho Women's Health, Ortho-McNeil Pharmaceutical, Inc., said in an interview.

“This study really doesn't shed any new light on this issue,” she said. “The definitive study, which would control for both sexual behavior and hormonal contraception, has yet to be done.”

However, it's important to continue emphasizing to women that no hormonal contraceptive method protects against sexually transmitted infection, Dr. LaGuardia said.

“Although safe and effective when used as labeled, these methods don't protect against infection,” she added. “Using a condom along with hormonal methods offers the best protection against both pregnancy and STIs, including HIV,” Dr. LaGuardia explained.

Bacterial vaginosis, high-density group B streptococcus colonization, and the use of hormonal contraceptives are all independently associated with increased risk of genital tract shedding of herpes simplex virus type 2, Thomas L. Cherpes, M.D., and his colleagues at the University of Pittsburgh reported.

These increased risks could be key factors in HSV-2 transmission.

“Because hormonal contraceptives are used by more than 100 million women worldwide, and because bacterial vaginosis and vaginal GBS colonization are two of the most common genital tract conditions present among women of reproductive age, even modest associations between these variables and genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus,” they reported (Clin. Infect. Dis. 2005;40:1422–8).

The researchers followed 330 HSV-2-positive women for a year. The women were aged 18–30 years; 65% were black. Every 4 months, the investigators collected behavioral data, vaginal swabs and smears, and a blood sample from each woman.

In the multivariate analysis, genital tract shedding was associated with recent HSV-2 seroconversion (odds ratio [OR] of 3), high-density group B streptococcus colonization (OR 2.2), bacterial vaginosis (OR 1.9), and the use of either depomedroxyprogesterone acetate or oral contraceptives (OR 1.8).

Genital tract shedding was not associated with vaginal intercourse, having a new sex partner, or douching.

The associations with bacterial vaginosis and high-density GBS colonization were somewhat of a surprise, the researchers said. “A number of recent studies have demonstrated that [bacterial vaginosis] is associated with significant alterations in the concentrations of several immunomodulatory cytokines, compared with the concentrations of these cytokines associated with normal vaginal flora.”

Oral contraceptives may influence shedding by different means, the researchers said. Suppression of estrogen and progesterone may alter the T cell-mediated immune response, and thereby increase shedding.

Additionally, women who use oral contraceptives can have larger areas of cervical ectopy. “This extension of the single-layered columnar epithelium onto the ectocervix may facilitate genital tract shedding.”

However, since the increased risk was the same for both oral and injectable hormonal contraceptives, and cervical ectopy is more commonly associated with the oral form, it may not be the predominate mechanism responsible for increased viral shedding, they said.

Previous studies on the subject have reached varying conclusions, Katherine LaGuardia, M.D., medical affairs director for Ortho Women's Health, Ortho-McNeil Pharmaceutical, Inc., said in an interview.

“This study really doesn't shed any new light on this issue,” she said. “The definitive study, which would control for both sexual behavior and hormonal contraception, has yet to be done.”

However, it's important to continue emphasizing to women that no hormonal contraceptive method protects against sexually transmitted infection, Dr. LaGuardia said.

“Although safe and effective when used as labeled, these methods don't protect against infection,” she added. “Using a condom along with hormonal methods offers the best protection against both pregnancy and STIs, including HIV,” Dr. LaGuardia explained.

ST. LOUIS — Patients previously vaccinated for smallpox will, with revaccination, experience a smaller erythematous response, a quicker time to pustulation, and a fourfold increase in antibody titers, compared with vaccine-naive patients.

“This provides important clinical evidence of retained immunity to smallpox, even in individuals vaccinated more than 30 years ago,” Eric Simpson, M.D., said at the annual meeting of the Society of Investigational Dermatology.

Also, said Dr. Simpson of Oregon Health and Science University, Portland, povidone ointment is effective for controlling viral shedding at the vaccination site. Within 2 hours, it decreases shedding to 0, and it has no effect on antibody titers.

Two recent studies have challenged the long-held theory that smallpox immunity lasts less than 10 years after vaccination, he said. A 2002 study showed that previously vaccinated individuals retained humoral immunity up to 75 years after vaccination. A 2003 study showed that previously vaccinated individuals could be successfully revaccinated with diluted vaccine, because of their more robust immune response.

In Dr. Simpson's study, 26 healthy adult volunteers were vaccinated; 17 of them had been vaccinated an average of 33 years earlier (range 2–50 years). The rest were vaccine naive. He used a standard vaccination protocol, with the previously vaccinated subjects receiving 15 pokes with a bifurcated needle, while the vaccine-naive group received 3 pokes.

Measurements included maximum erythema at the vaccine site and maximum time to pustulation. Dr. Simpson also studied the effect of povidone ointment on viral shedding, when applied starting day 7.

The previously vaccinated subjects had a significantly smaller maximum diameter of erythema around the vaccination site, compared with the naive group (1.9 cm vs. 3.9 cm). The previously vaccinated group developed an erythematous reaction more quickly, beginning at day 3, compared with day 6 for the naive group. Erythema for both groups peaked around day 10.

It's important that physicians be familiar with the differences in vaccination site reactions, he said.

Maximum time to pustulation was significantly shorter in the previously vaccinated group than in the naive group (about 7 days vs. 9.6 days).

The previously vaccinated group developed four times the antibody titers of the naive group, he said. “This explains the earlier finding that you can successfully vaccinate these patients with diluted vaccine.”

To study the effect of povidone ointment on viral shedding, Dr. Simpson applied the ointment to the vaccination site every 2–3 days, beginning at day 7. Viral shedding was measured 1 hour after the ointment was applied. “The shedding dropped to 0 within 1–2 hours and stayed that way throughout the entire vaccine response,” he said. “In the untreated group, viral shedding continued to occur until approximately day 20, which is around the time the eschar was shed.”

Smallpox vaccination site reaction is shown in a previously vaccinated patient.

Vaccination site reaction is shown in a smallpox vaccine-naive patient. Photos courtesy Dr. Eric Simpson

ST. LOUIS — Patients previously vaccinated for smallpox will, with revaccination, experience a smaller erythematous response, a quicker time to pustulation, and a fourfold increase in antibody titers, compared with vaccine-naive patients.

“This provides important clinical evidence of retained immunity to smallpox, even in individuals vaccinated more than 30 years ago,” Eric Simpson, M.D., said at the annual meeting of the Society of Investigational Dermatology.

Also, said Dr. Simpson of Oregon Health and Science University, Portland, povidone ointment is effective for controlling viral shedding at the vaccination site. Within 2 hours, it decreases shedding to 0, and it has no effect on antibody titers.

Two recent studies have challenged the long-held theory that smallpox immunity lasts less than 10 years after vaccination, he said. A 2002 study showed that previously vaccinated individuals retained humoral immunity up to 75 years after vaccination. A 2003 study showed that previously vaccinated individuals could be successfully revaccinated with diluted vaccine, because of their more robust immune response.

In Dr. Simpson's study, 26 healthy adult volunteers were vaccinated; 17 of them had been vaccinated an average of 33 years earlier (range 2–50 years). The rest were vaccine naive. He used a standard vaccination protocol, with the previously vaccinated subjects receiving 15 pokes with a bifurcated needle, while the vaccine-naive group received 3 pokes.

Measurements included maximum erythema at the vaccine site and maximum time to pustulation. Dr. Simpson also studied the effect of povidone ointment on viral shedding, when applied starting day 7.

The previously vaccinated subjects had a significantly smaller maximum diameter of erythema around the vaccination site, compared with the naive group (1.9 cm vs. 3.9 cm). The previously vaccinated group developed an erythematous reaction more quickly, beginning at day 3, compared with day 6 for the naive group. Erythema for both groups peaked around day 10.

It's important that physicians be familiar with the differences in vaccination site reactions, he said.

Maximum time to pustulation was significantly shorter in the previously vaccinated group than in the naive group (about 7 days vs. 9.6 days).

The previously vaccinated group developed four times the antibody titers of the naive group, he said. “This explains the earlier finding that you can successfully vaccinate these patients with diluted vaccine.”

To study the effect of povidone ointment on viral shedding, Dr. Simpson applied the ointment to the vaccination site every 2–3 days, beginning at day 7. Viral shedding was measured 1 hour after the ointment was applied. “The shedding dropped to 0 within 1–2 hours and stayed that way throughout the entire vaccine response,” he said. “In the untreated group, viral shedding continued to occur until approximately day 20, which is around the time the eschar was shed.”

Smallpox vaccination site reaction is shown in a previously vaccinated patient.

Vaccination site reaction is shown in a smallpox vaccine-naive patient. Photos courtesy Dr. Eric Simpson

ST. LOUIS — Patients previously vaccinated for smallpox will, with revaccination, experience a smaller erythematous response, a quicker time to pustulation, and a fourfold increase in antibody titers, compared with vaccine-naive patients.

“This provides important clinical evidence of retained immunity to smallpox, even in individuals vaccinated more than 30 years ago,” Eric Simpson, M.D., said at the annual meeting of the Society of Investigational Dermatology.

Also, said Dr. Simpson of Oregon Health and Science University, Portland, povidone ointment is effective for controlling viral shedding at the vaccination site. Within 2 hours, it decreases shedding to 0, and it has no effect on antibody titers.

Two recent studies have challenged the long-held theory that smallpox immunity lasts less than 10 years after vaccination, he said. A 2002 study showed that previously vaccinated individuals retained humoral immunity up to 75 years after vaccination. A 2003 study showed that previously vaccinated individuals could be successfully revaccinated with diluted vaccine, because of their more robust immune response.

In Dr. Simpson's study, 26 healthy adult volunteers were vaccinated; 17 of them had been vaccinated an average of 33 years earlier (range 2–50 years). The rest were vaccine naive. He used a standard vaccination protocol, with the previously vaccinated subjects receiving 15 pokes with a bifurcated needle, while the vaccine-naive group received 3 pokes.

Measurements included maximum erythema at the vaccine site and maximum time to pustulation. Dr. Simpson also studied the effect of povidone ointment on viral shedding, when applied starting day 7.

The previously vaccinated subjects had a significantly smaller maximum diameter of erythema around the vaccination site, compared with the naive group (1.9 cm vs. 3.9 cm). The previously vaccinated group developed an erythematous reaction more quickly, beginning at day 3, compared with day 6 for the naive group. Erythema for both groups peaked around day 10.

It's important that physicians be familiar with the differences in vaccination site reactions, he said.

Maximum time to pustulation was significantly shorter in the previously vaccinated group than in the naive group (about 7 days vs. 9.6 days).

The previously vaccinated group developed four times the antibody titers of the naive group, he said. “This explains the earlier finding that you can successfully vaccinate these patients with diluted vaccine.”

To study the effect of povidone ointment on viral shedding, Dr. Simpson applied the ointment to the vaccination site every 2–3 days, beginning at day 7. Viral shedding was measured 1 hour after the ointment was applied. “The shedding dropped to 0 within 1–2 hours and stayed that way throughout the entire vaccine response,” he said. “In the untreated group, viral shedding continued to occur until approximately day 20, which is around the time the eschar was shed.”

Smallpox vaccination site reaction is shown in a previously vaccinated patient.

Vaccination site reaction is shown in a smallpox vaccine-naive patient. Photos courtesy Dr. Eric Simpson