Jane Salodof MacNeil

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.

ASPEN, COLO.—Rapid antigen detection tests have a high false-negative rate, and cannot be relied upon to diagnosis strep throat without a confirmatory throat culture, according to S. Michael Marcy, M.D.

“Many people are using antigen detection tests alone. This is not what is recommended yet,” he said, urging caution in adopting the new tests at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

Throat culture is still the preferred method, advised Dr. Marcy of the University of Southern California and the University of California, Los Angeles.

In nearly all cases, he said antibiotics should not be prescribed until group A streptococcal infection is confirmed. One exception would be a very sick child presenting with doughnut-like papules that have white centers. “These are diagnostic,” he said.

The Centers for Disease Control and Prevention and the American Academy of Pediatrics say antibiotics may be prescribed without a culture if an antigen detection test is positive, according to Dr. Marcy.

If it is negative, both recommend the results be confirmed by a throat culture.

“The problem with antigen detection tests, in my opinion, is unless you get the answer immediately, you don't have a huge advantage,” he said.

In practices where tests are processed in a batch, Dr. Marcy said the results typically arrive after the parent has taken the child home. Then the family has to be called back for the confirmatory culture or sent to the pharmacy.

In his own practice at Kaiser Foundation Hospital in Panorama City, Calif., Dr. Marcy said he does not bother with the rapid test. Instead, he does a culture if strep is suspected and the clinical signs do not strongly suggest a viral etiology.

While waiting for the results, he prescribes acetaminophen to prevent fever and pain. “I tell parents about preventing rather than chasing the symptoms,” he said, calling acetaminophen “as good as penicillin” during the wait.

He also posts a chart published that illustrates how long cold and flu symptoms, including sore throat, persist. The chart tells parents that these are viral illnesses for which antibiotics will not work.

“Parents look at it and say, 'I don't need to see you,' “he recounted, calling the graphic “very useful.”

Only about 20% of throat cultures are positive for strep, according to Dr. Marcy. He cited a Finnish study that found a viral infection in 42% of children with febrile exudative pharyngitis; no pathogen was detected in 37%. While 37% had bacterial infections, just 12% of pathogens were group A streptococci (Pediatrics 1987;80:6–12). Coinfections brought the total above 100%.

Current recommendations call for throat cultures to be done with two swabs, Dr. Marcy noted.

He warned that samples must be taken from the right and left tonsils. “If you only touch one side, you will get a false negative 30% of the time. Three separate papers show that. You must touch them both.”

If group A strep is confirmed, amoxicillin is the treatment of choice, Dr. Marcy said. He recommended prescribing 750 mg once a day for 10 days. “Compliance is better” than it is with the twice-a-day option, he said, dismissing controversy over the efficacy of cephalosporin vs. penicillin as dated.

“What needs to be done at this time is [a trial comparing] cephalosporin vs. amoxicillin. This has to be done,” he said.

ASPEN, COLO.—Rapid antigen detection tests have a high false-negative rate, and cannot be relied upon to diagnosis strep throat without a confirmatory throat culture, according to S. Michael Marcy, M.D.

“Many people are using antigen detection tests alone. This is not what is recommended yet,” he said, urging caution in adopting the new tests at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

Throat culture is still the preferred method, advised Dr. Marcy of the University of Southern California and the University of California, Los Angeles.

In nearly all cases, he said antibiotics should not be prescribed until group A streptococcal infection is confirmed. One exception would be a very sick child presenting with doughnut-like papules that have white centers. “These are diagnostic,” he said.

The Centers for Disease Control and Prevention and the American Academy of Pediatrics say antibiotics may be prescribed without a culture if an antigen detection test is positive, according to Dr. Marcy.

If it is negative, both recommend the results be confirmed by a throat culture.

“The problem with antigen detection tests, in my opinion, is unless you get the answer immediately, you don't have a huge advantage,” he said.

In practices where tests are processed in a batch, Dr. Marcy said the results typically arrive after the parent has taken the child home. Then the family has to be called back for the confirmatory culture or sent to the pharmacy.

In his own practice at Kaiser Foundation Hospital in Panorama City, Calif., Dr. Marcy said he does not bother with the rapid test. Instead, he does a culture if strep is suspected and the clinical signs do not strongly suggest a viral etiology.

While waiting for the results, he prescribes acetaminophen to prevent fever and pain. “I tell parents about preventing rather than chasing the symptoms,” he said, calling acetaminophen “as good as penicillin” during the wait.

He also posts a chart published that illustrates how long cold and flu symptoms, including sore throat, persist. The chart tells parents that these are viral illnesses for which antibiotics will not work.

“Parents look at it and say, 'I don't need to see you,' “he recounted, calling the graphic “very useful.”

Only about 20% of throat cultures are positive for strep, according to Dr. Marcy. He cited a Finnish study that found a viral infection in 42% of children with febrile exudative pharyngitis; no pathogen was detected in 37%. While 37% had bacterial infections, just 12% of pathogens were group A streptococci (Pediatrics 1987;80:6–12). Coinfections brought the total above 100%.

Current recommendations call for throat cultures to be done with two swabs, Dr. Marcy noted.

He warned that samples must be taken from the right and left tonsils. “If you only touch one side, you will get a false negative 30% of the time. Three separate papers show that. You must touch them both.”

If group A strep is confirmed, amoxicillin is the treatment of choice, Dr. Marcy said. He recommended prescribing 750 mg once a day for 10 days. “Compliance is better” than it is with the twice-a-day option, he said, dismissing controversy over the efficacy of cephalosporin vs. penicillin as dated.

“What needs to be done at this time is [a trial comparing] cephalosporin vs. amoxicillin. This has to be done,” he said.

ASPEN, COLO.—Rapid antigen detection tests have a high false-negative rate, and cannot be relied upon to diagnosis strep throat without a confirmatory throat culture, according to S. Michael Marcy, M.D.

“Many people are using antigen detection tests alone. This is not what is recommended yet,” he said, urging caution in adopting the new tests at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

Throat culture is still the preferred method, advised Dr. Marcy of the University of Southern California and the University of California, Los Angeles.

In nearly all cases, he said antibiotics should not be prescribed until group A streptococcal infection is confirmed. One exception would be a very sick child presenting with doughnut-like papules that have white centers. “These are diagnostic,” he said.

The Centers for Disease Control and Prevention and the American Academy of Pediatrics say antibiotics may be prescribed without a culture if an antigen detection test is positive, according to Dr. Marcy.

If it is negative, both recommend the results be confirmed by a throat culture.

“The problem with antigen detection tests, in my opinion, is unless you get the answer immediately, you don't have a huge advantage,” he said.

In practices where tests are processed in a batch, Dr. Marcy said the results typically arrive after the parent has taken the child home. Then the family has to be called back for the confirmatory culture or sent to the pharmacy.

In his own practice at Kaiser Foundation Hospital in Panorama City, Calif., Dr. Marcy said he does not bother with the rapid test. Instead, he does a culture if strep is suspected and the clinical signs do not strongly suggest a viral etiology.

While waiting for the results, he prescribes acetaminophen to prevent fever and pain. “I tell parents about preventing rather than chasing the symptoms,” he said, calling acetaminophen “as good as penicillin” during the wait.

He also posts a chart published that illustrates how long cold and flu symptoms, including sore throat, persist. The chart tells parents that these are viral illnesses for which antibiotics will not work.

“Parents look at it and say, 'I don't need to see you,' “he recounted, calling the graphic “very useful.”

Only about 20% of throat cultures are positive for strep, according to Dr. Marcy. He cited a Finnish study that found a viral infection in 42% of children with febrile exudative pharyngitis; no pathogen was detected in 37%. While 37% had bacterial infections, just 12% of pathogens were group A streptococci (Pediatrics 1987;80:6–12). Coinfections brought the total above 100%.

Current recommendations call for throat cultures to be done with two swabs, Dr. Marcy noted.

He warned that samples must be taken from the right and left tonsils. “If you only touch one side, you will get a false negative 30% of the time. Three separate papers show that. You must touch them both.”

If group A strep is confirmed, amoxicillin is the treatment of choice, Dr. Marcy said. He recommended prescribing 750 mg once a day for 10 days. “Compliance is better” than it is with the twice-a-day option, he said, dismissing controversy over the efficacy of cephalosporin vs. penicillin as dated.

“What needs to be done at this time is [a trial comparing] cephalosporin vs. amoxicillin. This has to be done,” he said.

ORLANDO — Intriguing data from a prospective colon cancer trial suggest that aspirin and exercise might help protect survivors from recurrence of the disease.

Only 75 patients (8.9%) in the 846-patient trial reported regular aspirin use; the dosages ranged from 81 mg to 325 mg per day. At an average follow-up of 2.7 years after completion of treatment, their risk of recurrence and death was reduced by more than 50%, compared with patients who were occasional users.

A second analysis from the same trial found that the equivalent of walking an hour a day, 6 days a week, was associated with a 40%–50% reduction in risk over the same time period. “The [disease-free survival] hazard ratio of 0.55 is as strong an effect as seen for adjuvant chemotherapy as compared to observation,” the investigators noted.

Based on these findings, Jeffrey A. Meyerhardt, M.D., Ph.D., and his coinvestigators are urging further study of the potential of lifestyle changes to improve outcomes in colorectal cancer.

“Primary care doctors are going to see increasing numbers of cancer survivors, and we need to understand, we all need to understand, other things people can do once they are through with their treatment,” Dr. Meyerhardt said in an interview at the annual meeting of the American Society of Clinical Oncology.

Dr. Meyerhardt, an oncologist at the Dana-Farber Cancer Institute in Boston, presented two posters reporting the data on behalf of investigators from the multicenter Cancer and Leukemia Group B (CALGB) trial.

The prospective study assessed postoperative adjuvant chemotherapy regimens in stage 3 colon cancer patients.

Charles Fuchs, M.D., a professor of medicine at Dana-Farber, led the aspirin analysis, which was based on surveys conducted midway through and 6 months after adjuvant chemotherapy. About 830 patients completed both surveys.

The investigators also found a trend toward lower risk of recurrence in patients who reported using cyclooxygenase-2 inhibitors. Just 41 patients (4.7%) used rofecoxib or celecoxib. No benefit was documented for patients taking acetaminophen.

The physical activity data came from the survey conducted 6 months after completion of adjuvant chemotherapy. It excluded patients who had a recurrence or died within 3 months of the physical activity measurement.

The 832-patient physical activity study involved collection of information on a range of activities, which were assigned metabolic equivalent (MET) conversion scores for every hour reported. For example, walking at a normal pace for an hour was scored at 3. Bicycling for the same time period received 7 points.

The investigators concluded that the “protective effect was most apparent in patients engaging in at least 18 total MET-hours per week,” which they interpreted as the equivalent of walking 1 hour per day, 6 days a week.

Stratification by age, gender, baseline performance status, body mass index, and number of positive nodes did not alter the consistency of the results.

ORLANDO — Intriguing data from a prospective colon cancer trial suggest that aspirin and exercise might help protect survivors from recurrence of the disease.

Only 75 patients (8.9%) in the 846-patient trial reported regular aspirin use; the dosages ranged from 81 mg to 325 mg per day. At an average follow-up of 2.7 years after completion of treatment, their risk of recurrence and death was reduced by more than 50%, compared with patients who were occasional users.

A second analysis from the same trial found that the equivalent of walking an hour a day, 6 days a week, was associated with a 40%–50% reduction in risk over the same time period. “The [disease-free survival] hazard ratio of 0.55 is as strong an effect as seen for adjuvant chemotherapy as compared to observation,” the investigators noted.

Based on these findings, Jeffrey A. Meyerhardt, M.D., Ph.D., and his coinvestigators are urging further study of the potential of lifestyle changes to improve outcomes in colorectal cancer.

“Primary care doctors are going to see increasing numbers of cancer survivors, and we need to understand, we all need to understand, other things people can do once they are through with their treatment,” Dr. Meyerhardt said in an interview at the annual meeting of the American Society of Clinical Oncology.

Dr. Meyerhardt, an oncologist at the Dana-Farber Cancer Institute in Boston, presented two posters reporting the data on behalf of investigators from the multicenter Cancer and Leukemia Group B (CALGB) trial.

The prospective study assessed postoperative adjuvant chemotherapy regimens in stage 3 colon cancer patients.

Charles Fuchs, M.D., a professor of medicine at Dana-Farber, led the aspirin analysis, which was based on surveys conducted midway through and 6 months after adjuvant chemotherapy. About 830 patients completed both surveys.

The investigators also found a trend toward lower risk of recurrence in patients who reported using cyclooxygenase-2 inhibitors. Just 41 patients (4.7%) used rofecoxib or celecoxib. No benefit was documented for patients taking acetaminophen.

The physical activity data came from the survey conducted 6 months after completion of adjuvant chemotherapy. It excluded patients who had a recurrence or died within 3 months of the physical activity measurement.

The 832-patient physical activity study involved collection of information on a range of activities, which were assigned metabolic equivalent (MET) conversion scores for every hour reported. For example, walking at a normal pace for an hour was scored at 3. Bicycling for the same time period received 7 points.

The investigators concluded that the “protective effect was most apparent in patients engaging in at least 18 total MET-hours per week,” which they interpreted as the equivalent of walking 1 hour per day, 6 days a week.

Stratification by age, gender, baseline performance status, body mass index, and number of positive nodes did not alter the consistency of the results.

ORLANDO — Intriguing data from a prospective colon cancer trial suggest that aspirin and exercise might help protect survivors from recurrence of the disease.

Only 75 patients (8.9%) in the 846-patient trial reported regular aspirin use; the dosages ranged from 81 mg to 325 mg per day. At an average follow-up of 2.7 years after completion of treatment, their risk of recurrence and death was reduced by more than 50%, compared with patients who were occasional users.

A second analysis from the same trial found that the equivalent of walking an hour a day, 6 days a week, was associated with a 40%–50% reduction in risk over the same time period. “The [disease-free survival] hazard ratio of 0.55 is as strong an effect as seen for adjuvant chemotherapy as compared to observation,” the investigators noted.

Based on these findings, Jeffrey A. Meyerhardt, M.D., Ph.D., and his coinvestigators are urging further study of the potential of lifestyle changes to improve outcomes in colorectal cancer.

“Primary care doctors are going to see increasing numbers of cancer survivors, and we need to understand, we all need to understand, other things people can do once they are through with their treatment,” Dr. Meyerhardt said in an interview at the annual meeting of the American Society of Clinical Oncology.

Dr. Meyerhardt, an oncologist at the Dana-Farber Cancer Institute in Boston, presented two posters reporting the data on behalf of investigators from the multicenter Cancer and Leukemia Group B (CALGB) trial.

The prospective study assessed postoperative adjuvant chemotherapy regimens in stage 3 colon cancer patients.

Charles Fuchs, M.D., a professor of medicine at Dana-Farber, led the aspirin analysis, which was based on surveys conducted midway through and 6 months after adjuvant chemotherapy. About 830 patients completed both surveys.

The investigators also found a trend toward lower risk of recurrence in patients who reported using cyclooxygenase-2 inhibitors. Just 41 patients (4.7%) used rofecoxib or celecoxib. No benefit was documented for patients taking acetaminophen.

The physical activity data came from the survey conducted 6 months after completion of adjuvant chemotherapy. It excluded patients who had a recurrence or died within 3 months of the physical activity measurement.

The 832-patient physical activity study involved collection of information on a range of activities, which were assigned metabolic equivalent (MET) conversion scores for every hour reported. For example, walking at a normal pace for an hour was scored at 3. Bicycling for the same time period received 7 points.

The investigators concluded that the “protective effect was most apparent in patients engaging in at least 18 total MET-hours per week,” which they interpreted as the equivalent of walking 1 hour per day, 6 days a week.

Stratification by age, gender, baseline performance status, body mass index, and number of positive nodes did not alter the consistency of the results.

VERSAILLES, FRANCE — Custom-made foot orthoses produced immediate and significant benefits for juvenile idiopathic arthritis patients, according to the results of a study conducted in Stockholm.

Youngsters with cavovarus foot position showed the most pronounced improvements when they began wearing the device, investigator Marie André reported in a poster at the 12th European Pediatric Rheumatology Congress.

Children with oligoarthritis and polyarthritis had better results than those with enthesitis-related arthritis, according to Ms. André of Astrid Lindgren Children's Hospital at Karolinska University Hospital, and her colleagues.

“We know children need to be physically active,” she said in an interview at the meeting. “If you give them orthoses, there may be pain relief and … improvements in balance, and then maybe they can be more physically active.”

The youngsters, aged 8–17 years, performed five standardized capacity tests with and without orthoses: standing, jumping, running, climbing stairs, and walking 200 meters at their own pace. The researchers recorded walking and running times, and assessed balance capacity. With each test, the children rated their pain on a visual analog scale.

The most pronounced improvements were in balance and in pain scores while running. For each measure, 34 children had better results with their orthoses while 5 saw no change, and 9 fared worse.

Many children did significantly better on the timed walking test (31 improved, 3 unchanged, 14 worse). Pain scores were significantly improved when the children were standing (26 better, 14 unchanged, 8 worse), and climbing stairs (27 better, 10 unchanged, 11 worse).

The differences in pain while jumping and walking were not significant, however. Likewise, while 19 children had better running times with orthoses, 16 saw no change, and 13 performed worse.

“In this study we looked at improvement in immediate effects, but orthoses are a long-term treatment, and we are planning a long-term study, too,” she said.

VERSAILLES, FRANCE — Custom-made foot orthoses produced immediate and significant benefits for juvenile idiopathic arthritis patients, according to the results of a study conducted in Stockholm.

Youngsters with cavovarus foot position showed the most pronounced improvements when they began wearing the device, investigator Marie André reported in a poster at the 12th European Pediatric Rheumatology Congress.

Children with oligoarthritis and polyarthritis had better results than those with enthesitis-related arthritis, according to Ms. André of Astrid Lindgren Children's Hospital at Karolinska University Hospital, and her colleagues.

“We know children need to be physically active,” she said in an interview at the meeting. “If you give them orthoses, there may be pain relief and … improvements in balance, and then maybe they can be more physically active.”

The youngsters, aged 8–17 years, performed five standardized capacity tests with and without orthoses: standing, jumping, running, climbing stairs, and walking 200 meters at their own pace. The researchers recorded walking and running times, and assessed balance capacity. With each test, the children rated their pain on a visual analog scale.

The most pronounced improvements were in balance and in pain scores while running. For each measure, 34 children had better results with their orthoses while 5 saw no change, and 9 fared worse.

Many children did significantly better on the timed walking test (31 improved, 3 unchanged, 14 worse). Pain scores were significantly improved when the children were standing (26 better, 14 unchanged, 8 worse), and climbing stairs (27 better, 10 unchanged, 11 worse).

The differences in pain while jumping and walking were not significant, however. Likewise, while 19 children had better running times with orthoses, 16 saw no change, and 13 performed worse.

“In this study we looked at improvement in immediate effects, but orthoses are a long-term treatment, and we are planning a long-term study, too,” she said.

VERSAILLES, FRANCE — Custom-made foot orthoses produced immediate and significant benefits for juvenile idiopathic arthritis patients, according to the results of a study conducted in Stockholm.

Youngsters with cavovarus foot position showed the most pronounced improvements when they began wearing the device, investigator Marie André reported in a poster at the 12th European Pediatric Rheumatology Congress.

Children with oligoarthritis and polyarthritis had better results than those with enthesitis-related arthritis, according to Ms. André of Astrid Lindgren Children's Hospital at Karolinska University Hospital, and her colleagues.

“We know children need to be physically active,” she said in an interview at the meeting. “If you give them orthoses, there may be pain relief and … improvements in balance, and then maybe they can be more physically active.”

The youngsters, aged 8–17 years, performed five standardized capacity tests with and without orthoses: standing, jumping, running, climbing stairs, and walking 200 meters at their own pace. The researchers recorded walking and running times, and assessed balance capacity. With each test, the children rated their pain on a visual analog scale.

The most pronounced improvements were in balance and in pain scores while running. For each measure, 34 children had better results with their orthoses while 5 saw no change, and 9 fared worse.

Many children did significantly better on the timed walking test (31 improved, 3 unchanged, 14 worse). Pain scores were significantly improved when the children were standing (26 better, 14 unchanged, 8 worse), and climbing stairs (27 better, 10 unchanged, 11 worse).

The differences in pain while jumping and walking were not significant, however. Likewise, while 19 children had better running times with orthoses, 16 saw no change, and 13 performed worse.

“In this study we looked at improvement in immediate effects, but orthoses are a long-term treatment, and we are planning a long-term study, too,” she said.

VERSAILLES, FRANCE — A Dutch study of 21 adolescents with juvenile idiopathic arthritis found significant impairment in anaerobic fitness when the youngsters were asked to ride a bicycle as fast as they could.

At peak power, girls reached only 53% of the anaerobic fitness predicted for their weight, while boys did only slightly better, at 71%. Both genders also showed moderate impairment in aerobic fitness at peak power: The girls performed at 78% of predicted levels, and the boys performed at 83%.

“Their fitness is about 20% reduced, compared to normal children. … They don't feel at ease with exercise,” researcher Otto Lelieveld, a physical therapist, said in an interview at the annual scientific meeting of the European Pediatric Rheumatology Congress, where he presented the results in a poster.

Nine boys and 12 girls, aged 16–18, took part in the study. On average, 7.6 years had elapsed since the boys were diagnosed, and 8.9 years had elapsed for the girls.

The teenagers were required to perform the Wingate sprint test. Mr. Lelieveld of University Medical Center Groningen (the Netherlands) described this as 5 minutes of steady bicycle riding at low speed, followed by a 30-second sprint at peak power.

Study participants did slightly better in measurements of mean power, both aerobic and anaerobic, during the first part of the test, but still showed moderate impairment. In the measurement of muscle endurance, the boys achieved 78% of the mean anaerobic fitness predicted for their weight; the girls achieved 68%. Mean aerobic fitness reached 83% of prediction for the boys and 78% for the girls.

Based on these results, Mr. Lelieveld and his coinvestigators called for the development of exercise programs with more anaerobic and aerobic training for children with juvenile idiopathic arthritis.

“We know now from adult rheumatology that physical therapists are training at too low a level,” he said.

The children also are afraid to train themselves, he added. “When they are in remission they can have more pain than in the period when they are acute,” he said. “When they start functioning at a higher level, they put more strain on their joints. It is like a vicious circle.”

VERSAILLES, FRANCE — A Dutch study of 21 adolescents with juvenile idiopathic arthritis found significant impairment in anaerobic fitness when the youngsters were asked to ride a bicycle as fast as they could.

At peak power, girls reached only 53% of the anaerobic fitness predicted for their weight, while boys did only slightly better, at 71%. Both genders also showed moderate impairment in aerobic fitness at peak power: The girls performed at 78% of predicted levels, and the boys performed at 83%.

“Their fitness is about 20% reduced, compared to normal children. … They don't feel at ease with exercise,” researcher Otto Lelieveld, a physical therapist, said in an interview at the annual scientific meeting of the European Pediatric Rheumatology Congress, where he presented the results in a poster.

Nine boys and 12 girls, aged 16–18, took part in the study. On average, 7.6 years had elapsed since the boys were diagnosed, and 8.9 years had elapsed for the girls.

The teenagers were required to perform the Wingate sprint test. Mr. Lelieveld of University Medical Center Groningen (the Netherlands) described this as 5 minutes of steady bicycle riding at low speed, followed by a 30-second sprint at peak power.

Study participants did slightly better in measurements of mean power, both aerobic and anaerobic, during the first part of the test, but still showed moderate impairment. In the measurement of muscle endurance, the boys achieved 78% of the mean anaerobic fitness predicted for their weight; the girls achieved 68%. Mean aerobic fitness reached 83% of prediction for the boys and 78% for the girls.

Based on these results, Mr. Lelieveld and his coinvestigators called for the development of exercise programs with more anaerobic and aerobic training for children with juvenile idiopathic arthritis.

“We know now from adult rheumatology that physical therapists are training at too low a level,” he said.

The children also are afraid to train themselves, he added. “When they are in remission they can have more pain than in the period when they are acute,” he said. “When they start functioning at a higher level, they put more strain on their joints. It is like a vicious circle.”

VERSAILLES, FRANCE — A Dutch study of 21 adolescents with juvenile idiopathic arthritis found significant impairment in anaerobic fitness when the youngsters were asked to ride a bicycle as fast as they could.

At peak power, girls reached only 53% of the anaerobic fitness predicted for their weight, while boys did only slightly better, at 71%. Both genders also showed moderate impairment in aerobic fitness at peak power: The girls performed at 78% of predicted levels, and the boys performed at 83%.

“Their fitness is about 20% reduced, compared to normal children. … They don't feel at ease with exercise,” researcher Otto Lelieveld, a physical therapist, said in an interview at the annual scientific meeting of the European Pediatric Rheumatology Congress, where he presented the results in a poster.

Nine boys and 12 girls, aged 16–18, took part in the study. On average, 7.6 years had elapsed since the boys were diagnosed, and 8.9 years had elapsed for the girls.

The teenagers were required to perform the Wingate sprint test. Mr. Lelieveld of University Medical Center Groningen (the Netherlands) described this as 5 minutes of steady bicycle riding at low speed, followed by a 30-second sprint at peak power.

Study participants did slightly better in measurements of mean power, both aerobic and anaerobic, during the first part of the test, but still showed moderate impairment. In the measurement of muscle endurance, the boys achieved 78% of the mean anaerobic fitness predicted for their weight; the girls achieved 68%. Mean aerobic fitness reached 83% of prediction for the boys and 78% for the girls.

Based on these results, Mr. Lelieveld and his coinvestigators called for the development of exercise programs with more anaerobic and aerobic training for children with juvenile idiopathic arthritis.

“We know now from adult rheumatology that physical therapists are training at too low a level,” he said.

The children also are afraid to train themselves, he added. “When they are in remission they can have more pain than in the period when they are acute,” he said. “When they start functioning at a higher level, they put more strain on their joints. It is like a vicious circle.”

VERSAILLES, FRANCE — Investigators at the Baylor Institute for Immunology Research in Dallas have identified 12 genes that can distinguish systemic-onset juvenile idiopathic arthritis from other inflammatory conditions as well as from healthy controls.

The genes are part of a newly discovered 88-gene signature for systemic-onset juvenile idiopathic arthritis (SOJIA), Virginia Pascual, M.D., reported in a presentation at the 12th European Pediatric Rheumatology Congress.

“Most of them are genes that have not been characterized. I wish I could tell you more. It is not that I want to hide them,” she told audience members who sought more information.

Dr. Pascual, who is also affiliated with the Texas Scottish Rite Hospital for Children in Dallas, said the researchers initially identified 50 genes associated with the disease by comparing 873 genes in microarrays from 44 SOJIA patients.

Among the SOJIA patients, 16 (group 1) presented with fever and arthritis. Nine (group 2) had recovered from fever but still had arthritis. Nineteen intermittent patients were in remission (group 3) and did not have fever or arthritis.

Distinguishing microarrays of the SOJIA patients from those of healthy controls turned out to be easy, according to Dr. Pascual. She reported that the investigators were able to identify group 1 with 100% accuracy, group 2 with 96% accuracy, and the patients in remission with 86% accuracy.

The “diagnostic challenge” was not to distinguish SOJIA patients from healthy children, she continued, but from those with other inflammatory conditions. When investigators looked at arrays from children with Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, influenza A, and systemic lupus erythematosus, it became apparent that many of the same genes were overexpressed in these other conditions as well as in SOJIA.

“Many genes that we find are shared by all these conditions, so we have to dig deeper, and we have done it,” she said.

To find genes more specific to SOJIA, the researchers screened 4,311 genes, which they eventually refined to the 88-gene signature. Among these, Dr. Pascual reported 12 appeared to be enough to distinguish SOJIA patients not only from healthy controls but also from those with the other infectious diseases; lupus; and pyogenic arthritis, pyoderma gangrenosum, and acne (PAPA) syndrome. The genes in the signature “seem to be specific so far. They are very stable,” she said.

Among patients with active disease, those with a full clinical response to treatment also had a significant change in the signature, according to Dr. Pascual. Meanwhile, patients with weaker clinical responses showed lesser changes in the genetic signature.

“We are very interested in following these patients,” Dr. Pascual said of the ongoing investigation. “It is going to be very important to find markers that can predict response to therapy.”

VERSAILLES, FRANCE — Investigators at the Baylor Institute for Immunology Research in Dallas have identified 12 genes that can distinguish systemic-onset juvenile idiopathic arthritis from other inflammatory conditions as well as from healthy controls.

The genes are part of a newly discovered 88-gene signature for systemic-onset juvenile idiopathic arthritis (SOJIA), Virginia Pascual, M.D., reported in a presentation at the 12th European Pediatric Rheumatology Congress.

“Most of them are genes that have not been characterized. I wish I could tell you more. It is not that I want to hide them,” she told audience members who sought more information.

Dr. Pascual, who is also affiliated with the Texas Scottish Rite Hospital for Children in Dallas, said the researchers initially identified 50 genes associated with the disease by comparing 873 genes in microarrays from 44 SOJIA patients.

Among the SOJIA patients, 16 (group 1) presented with fever and arthritis. Nine (group 2) had recovered from fever but still had arthritis. Nineteen intermittent patients were in remission (group 3) and did not have fever or arthritis.

Distinguishing microarrays of the SOJIA patients from those of healthy controls turned out to be easy, according to Dr. Pascual. She reported that the investigators were able to identify group 1 with 100% accuracy, group 2 with 96% accuracy, and the patients in remission with 86% accuracy.

The “diagnostic challenge” was not to distinguish SOJIA patients from healthy children, she continued, but from those with other inflammatory conditions. When investigators looked at arrays from children with Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, influenza A, and systemic lupus erythematosus, it became apparent that many of the same genes were overexpressed in these other conditions as well as in SOJIA.

“Many genes that we find are shared by all these conditions, so we have to dig deeper, and we have done it,” she said.

To find genes more specific to SOJIA, the researchers screened 4,311 genes, which they eventually refined to the 88-gene signature. Among these, Dr. Pascual reported 12 appeared to be enough to distinguish SOJIA patients not only from healthy controls but also from those with the other infectious diseases; lupus; and pyogenic arthritis, pyoderma gangrenosum, and acne (PAPA) syndrome. The genes in the signature “seem to be specific so far. They are very stable,” she said.

Among patients with active disease, those with a full clinical response to treatment also had a significant change in the signature, according to Dr. Pascual. Meanwhile, patients with weaker clinical responses showed lesser changes in the genetic signature.

“We are very interested in following these patients,” Dr. Pascual said of the ongoing investigation. “It is going to be very important to find markers that can predict response to therapy.”

VERSAILLES, FRANCE — Investigators at the Baylor Institute for Immunology Research in Dallas have identified 12 genes that can distinguish systemic-onset juvenile idiopathic arthritis from other inflammatory conditions as well as from healthy controls.

The genes are part of a newly discovered 88-gene signature for systemic-onset juvenile idiopathic arthritis (SOJIA), Virginia Pascual, M.D., reported in a presentation at the 12th European Pediatric Rheumatology Congress.

“Most of them are genes that have not been characterized. I wish I could tell you more. It is not that I want to hide them,” she told audience members who sought more information.

Dr. Pascual, who is also affiliated with the Texas Scottish Rite Hospital for Children in Dallas, said the researchers initially identified 50 genes associated with the disease by comparing 873 genes in microarrays from 44 SOJIA patients.

Among the SOJIA patients, 16 (group 1) presented with fever and arthritis. Nine (group 2) had recovered from fever but still had arthritis. Nineteen intermittent patients were in remission (group 3) and did not have fever or arthritis.

Distinguishing microarrays of the SOJIA patients from those of healthy controls turned out to be easy, according to Dr. Pascual. She reported that the investigators were able to identify group 1 with 100% accuracy, group 2 with 96% accuracy, and the patients in remission with 86% accuracy.

The “diagnostic challenge” was not to distinguish SOJIA patients from healthy children, she continued, but from those with other inflammatory conditions. When investigators looked at arrays from children with Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, influenza A, and systemic lupus erythematosus, it became apparent that many of the same genes were overexpressed in these other conditions as well as in SOJIA.

“Many genes that we find are shared by all these conditions, so we have to dig deeper, and we have done it,” she said.

To find genes more specific to SOJIA, the researchers screened 4,311 genes, which they eventually refined to the 88-gene signature. Among these, Dr. Pascual reported 12 appeared to be enough to distinguish SOJIA patients not only from healthy controls but also from those with the other infectious diseases; lupus; and pyogenic arthritis, pyoderma gangrenosum, and acne (PAPA) syndrome. The genes in the signature “seem to be specific so far. They are very stable,” she said.

Among patients with active disease, those with a full clinical response to treatment also had a significant change in the signature, according to Dr. Pascual. Meanwhile, patients with weaker clinical responses showed lesser changes in the genetic signature.

“We are very interested in following these patients,” Dr. Pascual said of the ongoing investigation. “It is going to be very important to find markers that can predict response to therapy.”

VERSAILLES, FRANCE — Anakinra (Kineret) is effective against systemic-onset juvenile idiopathic arthritis, Marilynn Punaro, M.D., reported at the annual scientific meeting of the European Pediatric Rheumatology Congress.

Twelve of 13 children treated at Texas Scottish Rite Hospital for Children in Dallas responded to anakinra, an interleukin-1 receptor antagonist, according to a retrospective chart review presented by Dr. Punaro of the University of Texas Southwestern Medical School at Dallas.

Fever resolved immediately in most cases. Arthritis symptoms improved more slowly, but Dr. Punaro reported they had largely abated at an average follow-up of 14 months.

Eight children had complete sustained responses, she said. Two children, described as “substantially improved,” had partial sustained responses. Dr. Punaro noted that one went from active involvement of 34 joints to just two active joints.

Two others, who had complete transient responses, flared after infections. Only one child, described as “the most persistently active patient,” did not benefit and has been taken off drug for lack of efficacy.

The children, nine girls and four boys, ranged in age from 2 to 17 years when they started on anakinra. Their average duration of disease was 44 months, with a range of 1–142 months. Four were having flares at the initiation of anakinra, according to Dr. Punaro.

Before anakinra therapy, most patients were taking other agents, including corticosteroid, intravenous methylprednisone and/or methotrexate. Two children discontinued infliximab when they started on anakinra.

After anakinra, none of the children continued intravenous methylprednisone, according to Dr. Punaro. Physicians were able to taper the doses of all 11 children on corticosteroids.

While injection site complaints were common, she said infections were a major problem. These include three cases of upper respiratory tract infections, two of influenza, and one each of gastroenteritis, staphylococcus skin infection, and possible sepsis. Dr. Punaro noted that most patients continued on anakinra during infections against medical advice.

She said side effects did not increase with dose increases in children who did not respond initially. “The real question here is, what is the dose?” she said. “Nobody knows the answer to that.”

Microarray analyses showed a direct correlation between degree of clinical and genetic responses, Dr. Punaro added. She showed microarrays for three complete responders in which a genetic signature for systemic-onset juvenile idiopathic arthritis was virtually suppressed. Changes in gene expression were less dramatic by comparison in children with lesser responses.

“These are very preliminary data, but they suggest that [anakinra] may be useful,” she said.

VERSAILLES, FRANCE — Anakinra (Kineret) is effective against systemic-onset juvenile idiopathic arthritis, Marilynn Punaro, M.D., reported at the annual scientific meeting of the European Pediatric Rheumatology Congress.

Twelve of 13 children treated at Texas Scottish Rite Hospital for Children in Dallas responded to anakinra, an interleukin-1 receptor antagonist, according to a retrospective chart review presented by Dr. Punaro of the University of Texas Southwestern Medical School at Dallas.

Fever resolved immediately in most cases. Arthritis symptoms improved more slowly, but Dr. Punaro reported they had largely abated at an average follow-up of 14 months.

Eight children had complete sustained responses, she said. Two children, described as “substantially improved,” had partial sustained responses. Dr. Punaro noted that one went from active involvement of 34 joints to just two active joints.

Two others, who had complete transient responses, flared after infections. Only one child, described as “the most persistently active patient,” did not benefit and has been taken off drug for lack of efficacy.

The children, nine girls and four boys, ranged in age from 2 to 17 years when they started on anakinra. Their average duration of disease was 44 months, with a range of 1–142 months. Four were having flares at the initiation of anakinra, according to Dr. Punaro.

Before anakinra therapy, most patients were taking other agents, including corticosteroid, intravenous methylprednisone and/or methotrexate. Two children discontinued infliximab when they started on anakinra.

After anakinra, none of the children continued intravenous methylprednisone, according to Dr. Punaro. Physicians were able to taper the doses of all 11 children on corticosteroids.

While injection site complaints were common, she said infections were a major problem. These include three cases of upper respiratory tract infections, two of influenza, and one each of gastroenteritis, staphylococcus skin infection, and possible sepsis. Dr. Punaro noted that most patients continued on anakinra during infections against medical advice.

She said side effects did not increase with dose increases in children who did not respond initially. “The real question here is, what is the dose?” she said. “Nobody knows the answer to that.”

Microarray analyses showed a direct correlation between degree of clinical and genetic responses, Dr. Punaro added. She showed microarrays for three complete responders in which a genetic signature for systemic-onset juvenile idiopathic arthritis was virtually suppressed. Changes in gene expression were less dramatic by comparison in children with lesser responses.

“These are very preliminary data, but they suggest that [anakinra] may be useful,” she said.

VERSAILLES, FRANCE — Anakinra (Kineret) is effective against systemic-onset juvenile idiopathic arthritis, Marilynn Punaro, M.D., reported at the annual scientific meeting of the European Pediatric Rheumatology Congress.

Twelve of 13 children treated at Texas Scottish Rite Hospital for Children in Dallas responded to anakinra, an interleukin-1 receptor antagonist, according to a retrospective chart review presented by Dr. Punaro of the University of Texas Southwestern Medical School at Dallas.

Fever resolved immediately in most cases. Arthritis symptoms improved more slowly, but Dr. Punaro reported they had largely abated at an average follow-up of 14 months.

Eight children had complete sustained responses, she said. Two children, described as “substantially improved,” had partial sustained responses. Dr. Punaro noted that one went from active involvement of 34 joints to just two active joints.

Two others, who had complete transient responses, flared after infections. Only one child, described as “the most persistently active patient,” did not benefit and has been taken off drug for lack of efficacy.

The children, nine girls and four boys, ranged in age from 2 to 17 years when they started on anakinra. Their average duration of disease was 44 months, with a range of 1–142 months. Four were having flares at the initiation of anakinra, according to Dr. Punaro.

Before anakinra therapy, most patients were taking other agents, including corticosteroid, intravenous methylprednisone and/or methotrexate. Two children discontinued infliximab when they started on anakinra.

After anakinra, none of the children continued intravenous methylprednisone, according to Dr. Punaro. Physicians were able to taper the doses of all 11 children on corticosteroids.

While injection site complaints were common, she said infections were a major problem. These include three cases of upper respiratory tract infections, two of influenza, and one each of gastroenteritis, staphylococcus skin infection, and possible sepsis. Dr. Punaro noted that most patients continued on anakinra during infections against medical advice.

She said side effects did not increase with dose increases in children who did not respond initially. “The real question here is, what is the dose?” she said. “Nobody knows the answer to that.”

Microarray analyses showed a direct correlation between degree of clinical and genetic responses, Dr. Punaro added. She showed microarrays for three complete responders in which a genetic signature for systemic-onset juvenile idiopathic arthritis was virtually suppressed. Changes in gene expression were less dramatic by comparison in children with lesser responses.

“These are very preliminary data, but they suggest that [anakinra] may be useful,” she said.

ASPEN, COLO. — Two groups of immunocompromised children present special challenges in community-based practices, Elizabeth J. McFarland, M.D., said at a conference on pediatric infectious diseases, sponsored by Children's Hospital, Denver.

Weakened immune systems can make some vaccinations worrisome for youngsters taking high-dose steroids to control asthma or rheumatic diseases and can make other vaccinations vital for children without a spleen, said Dr. McFarland, director of the hospital's immunodeficiency clinic.

Even more serious, she warned, is the risk of sepsis, with high mortality rates from postsplenectomy sepsis. One-half of sepsis cases occur within 2 years of spleen removal, but 3% have been documented 20 years afterward (Br. J. Surg. 1991;78:1031–8).

Steroid Concerns

Dr. McFarland acknowledged that steroids are “important drugs” for controlling inflammation. The problem is that by interfering with cytokine production and lessening immune cell activity, steroids reduce the body's “ability to mount immune response or react to vaccine.”

According to Dr. McFarland, the American Academy of Pediatrics supports giving inactivated virus vaccines to children who are prescribed steroids, but she cautions that immunogenicity is uncertain. Live virus vaccines should be delayed until high-dose steroids are stopped.

If children take a high-dose steroid daily or on alternate days for more than 14 days, doctors should wait 1 month after stopping steroid use before giving vaccines, Dr. McFarland said. She also said that if the dosage period is less than 14 days, live virus vaccines can be given after stopping, but some experts recommend waiting 2 weeks.

AAP recommends inactivated influenza vaccine for patients with asthma. Dr. McFarland said studies have shown similar antibody responses to the influenza vaccine in patients receiving inhaled steroids and short-course oral steroids, when compared with patients not receiving steroids at the time of immunization.

The live varicella zoster virus (VZV) vaccine is not recommended during high-dose steroid use, because vaccine safety is not established in this population. However, Dr. McFarland said a health maintenance organization study found that inhaled steroids given 3 months prior to VZV vaccination were not associated with increased risk of breakthrough disease (Pediatrics 2003; 112:e98-e113), but the study did find increased breakthrough disease after VZV vaccination when oral steroids were given in the 3 months prior.

Postsplenectomy Issues

European studies have shown that about a quarter of physicians do not comply with guidelines for postsplenectomy care, Dr. McFarland said. She could not find any similar studies in the United States.

Although splenectomies in children may be necessary after trauma, she said the operation is being done less often owing to greater recognition of the spleen's importance to immune defense and to newer splenic salvage techniques.

Dr. McFarland urged pneumococcal vaccination for postsplenectomy patients. About two-thirds of sepsis cases have been traced to Streptococcus pneumoniae in this population.

If the regular pneumococcal conjugate vaccine (PCV) series was not given before age 24 months, doctors should give two doses of PCV, she said. She recommended one dose of pneumococcal polysaccharide vaccine 6–8 weeks after PCV, and a second dose 3–5 years afterward.

Postsplenectomy patients also should be vaccinated against meningococcus, according to Dr. McFarland. The new meningococcal conjugate vaccine (MCV4) is preferred for patients aged 11–55; only meningococcal polysaccharide vaccine (MPSV4) is approved for patients aged 2–11. Optimally, vaccinations for the encapsulated bacteria should be given prior to a planned splenectomy.

She suggested giving an extra dose of Haemophilus influenzae type b (Hib) vaccine prior to splenectomy, if possible. Afterward, these children also should receive annual influenza shots, she said.

Daily antibiotic prophylaxis is recommended, especially in the first 2 years after splenectomy.

However, Dr. McFarland said the randomized studies supporting its use were performed in young sickle cell anemia patients with functional asplenia.

Determining when to discontinue daily prophylaxis is difficult, she said, as there are no direct data for children with splenectomies. Physicians should discuss the risks and benefits with their patients. The recommended dosages are 125 mg of penicillin V twice daily in children under age 5 and 250 mg twice daily in children over age 5; some experts use amoxicillin (20 mg/kg daily).

Empiric therapy is another option, often used if daily prophylaxis is discontinued. At the first sign of a fever, the parents administer a dose of oral antibiotics and then bring in the child “pronto” for further evaluation. Dr. McFarland recommended 50 mg/kg of amoxicillin/clavulanate potassium (Augmentin) divided into 2–3 dosages daily or an alternative, possibly a cephalosporin, if the child is allergic to penicillin.

Pneumococcal resistance to penicillin is a concern, she said, and she urged physicians to find out the rate in their community. For sepsis cases, however, she recommended starting with vancomycin and a cephalosporin.

Without a spleen, patients also are at high risk for malaria and other insect-borne infections. Physicians should ask about mosquito and tick exposure and teach parents travel precautions.

Indeed, family education is a priority when caring for a child who has lost a spleen. “You need to give them something written, as you want them to understand the risk of infection,” she said. “And you want to do it more than once.”

Teach Parents About Zoonoses

Many physicians—Dr. McFarland among them—do not have the heart to banish all pets from the home of an immunocompromised child.

“The better you can take care of your animal … the less likely your pet will get sick,” is the message she urged physicians to give to parents of immunocompromised patients. Keeping the animal healthy will help the child stay well.

Dr. McFarland said the U.S. Public Health Service has identified five zoonoses of particular concern that immunocompromised children can pick up from animals: salmonellosis, campylobacteriosis, bacillary angiomatosis (Bartonella henselae, or cat scratch disease), cryptosporidiosis, and toxoplasmosis.

She also summarized the benefits of pet ownership, including decreased loneliness and increased feeling of intimacy and constancy.

The first principle of pet safety, she said, is to buy or adopt a healthy animal, preferably an adult. Young animals are more vulnerable to pathogens. No animal with diarrhea should be handled by the child.

Second, keep the animal healthy by preventing exposure to pathogens. Don't let cats or dogs roam. Fleas and ticks are a concern, as well as exposure to other animals and their feces, and anything else the pet might eat off the street.

Keep the animal inside, and keep the toilet seat down so the pet does not use the fixture as a fountain. Feed the animal well, and make sure it does not get into the garbage.

Third, avoid all contact with feces.

Dr. McFarland offered additional recommendations for patients, including children, who undergo hematopoietic stem cell transplants (MMWR 2000;49[RR10]:1–128). Parents should be advised of the risks, but children don't need to be forced to part with their pets.

Animals should be fed high-quality commercial pet food, according to Dr. McFarland, and at the first suspicion of a pet's illness, the animal should be taken to the vet.

Even with these precautions, some animals are prohibited as pets. She listed all reptiles (with a warning against reptile fomites), ducklings or chicks, and exotic pets, including nonhuman primates.

For more information, including brochures to download, Dr. McFarland recommended referring parents to

www.cdc.gov/healthypets

ASPEN, COLO. — Two groups of immunocompromised children present special challenges in community-based practices, Elizabeth J. McFarland, M.D., said at a conference on pediatric infectious diseases, sponsored by Children's Hospital, Denver.

Weakened immune systems can make some vaccinations worrisome for youngsters taking high-dose steroids to control asthma or rheumatic diseases and can make other vaccinations vital for children without a spleen, said Dr. McFarland, director of the hospital's immunodeficiency clinic.

Even more serious, she warned, is the risk of sepsis, with high mortality rates from postsplenectomy sepsis. One-half of sepsis cases occur within 2 years of spleen removal, but 3% have been documented 20 years afterward (Br. J. Surg. 1991;78:1031–8).

Steroid Concerns

Dr. McFarland acknowledged that steroids are “important drugs” for controlling inflammation. The problem is that by interfering with cytokine production and lessening immune cell activity, steroids reduce the body's “ability to mount immune response or react to vaccine.”

According to Dr. McFarland, the American Academy of Pediatrics supports giving inactivated virus vaccines to children who are prescribed steroids, but she cautions that immunogenicity is uncertain. Live virus vaccines should be delayed until high-dose steroids are stopped.

If children take a high-dose steroid daily or on alternate days for more than 14 days, doctors should wait 1 month after stopping steroid use before giving vaccines, Dr. McFarland said. She also said that if the dosage period is less than 14 days, live virus vaccines can be given after stopping, but some experts recommend waiting 2 weeks.

AAP recommends inactivated influenza vaccine for patients with asthma. Dr. McFarland said studies have shown similar antibody responses to the influenza vaccine in patients receiving inhaled steroids and short-course oral steroids, when compared with patients not receiving steroids at the time of immunization.

The live varicella zoster virus (VZV) vaccine is not recommended during high-dose steroid use, because vaccine safety is not established in this population. However, Dr. McFarland said a health maintenance organization study found that inhaled steroids given 3 months prior to VZV vaccination were not associated with increased risk of breakthrough disease (Pediatrics 2003; 112:e98-e113), but the study did find increased breakthrough disease after VZV vaccination when oral steroids were given in the 3 months prior.

Postsplenectomy Issues

European studies have shown that about a quarter of physicians do not comply with guidelines for postsplenectomy care, Dr. McFarland said. She could not find any similar studies in the United States.

Although splenectomies in children may be necessary after trauma, she said the operation is being done less often owing to greater recognition of the spleen's importance to immune defense and to newer splenic salvage techniques.

Dr. McFarland urged pneumococcal vaccination for postsplenectomy patients. About two-thirds of sepsis cases have been traced to Streptococcus pneumoniae in this population.

If the regular pneumococcal conjugate vaccine (PCV) series was not given before age 24 months, doctors should give two doses of PCV, she said. She recommended one dose of pneumococcal polysaccharide vaccine 6–8 weeks after PCV, and a second dose 3–5 years afterward.

Postsplenectomy patients also should be vaccinated against meningococcus, according to Dr. McFarland. The new meningococcal conjugate vaccine (MCV4) is preferred for patients aged 11–55; only meningococcal polysaccharide vaccine (MPSV4) is approved for patients aged 2–11. Optimally, vaccinations for the encapsulated bacteria should be given prior to a planned splenectomy.

She suggested giving an extra dose of Haemophilus influenzae type b (Hib) vaccine prior to splenectomy, if possible. Afterward, these children also should receive annual influenza shots, she said.

Daily antibiotic prophylaxis is recommended, especially in the first 2 years after splenectomy.

However, Dr. McFarland said the randomized studies supporting its use were performed in young sickle cell anemia patients with functional asplenia.

Determining when to discontinue daily prophylaxis is difficult, she said, as there are no direct data for children with splenectomies. Physicians should discuss the risks and benefits with their patients. The recommended dosages are 125 mg of penicillin V twice daily in children under age 5 and 250 mg twice daily in children over age 5; some experts use amoxicillin (20 mg/kg daily).

Empiric therapy is another option, often used if daily prophylaxis is discontinued. At the first sign of a fever, the parents administer a dose of oral antibiotics and then bring in the child “pronto” for further evaluation. Dr. McFarland recommended 50 mg/kg of amoxicillin/clavulanate potassium (Augmentin) divided into 2–3 dosages daily or an alternative, possibly a cephalosporin, if the child is allergic to penicillin.

Pneumococcal resistance to penicillin is a concern, she said, and she urged physicians to find out the rate in their community. For sepsis cases, however, she recommended starting with vancomycin and a cephalosporin.

Without a spleen, patients also are at high risk for malaria and other insect-borne infections. Physicians should ask about mosquito and tick exposure and teach parents travel precautions.

Indeed, family education is a priority when caring for a child who has lost a spleen. “You need to give them something written, as you want them to understand the risk of infection,” she said. “And you want to do it more than once.”

Teach Parents About Zoonoses

Many physicians—Dr. McFarland among them—do not have the heart to banish all pets from the home of an immunocompromised child.

“The better you can take care of your animal … the less likely your pet will get sick,” is the message she urged physicians to give to parents of immunocompromised patients. Keeping the animal healthy will help the child stay well.

Dr. McFarland said the U.S. Public Health Service has identified five zoonoses of particular concern that immunocompromised children can pick up from animals: salmonellosis, campylobacteriosis, bacillary angiomatosis (Bartonella henselae, or cat scratch disease), cryptosporidiosis, and toxoplasmosis.

She also summarized the benefits of pet ownership, including decreased loneliness and increased feeling of intimacy and constancy.

The first principle of pet safety, she said, is to buy or adopt a healthy animal, preferably an adult. Young animals are more vulnerable to pathogens. No animal with diarrhea should be handled by the child.

Second, keep the animal healthy by preventing exposure to pathogens. Don't let cats or dogs roam. Fleas and ticks are a concern, as well as exposure to other animals and their feces, and anything else the pet might eat off the street.

Keep the animal inside, and keep the toilet seat down so the pet does not use the fixture as a fountain. Feed the animal well, and make sure it does not get into the garbage.

Third, avoid all contact with feces.

Dr. McFarland offered additional recommendations for patients, including children, who undergo hematopoietic stem cell transplants (MMWR 2000;49[RR10]:1–128). Parents should be advised of the risks, but children don't need to be forced to part with their pets.

Animals should be fed high-quality commercial pet food, according to Dr. McFarland, and at the first suspicion of a pet's illness, the animal should be taken to the vet.

Even with these precautions, some animals are prohibited as pets. She listed all reptiles (with a warning against reptile fomites), ducklings or chicks, and exotic pets, including nonhuman primates.

For more information, including brochures to download, Dr. McFarland recommended referring parents to

www.cdc.gov/healthypets

ASPEN, COLO. — Two groups of immunocompromised children present special challenges in community-based practices, Elizabeth J. McFarland, M.D., said at a conference on pediatric infectious diseases, sponsored by Children's Hospital, Denver.

Weakened immune systems can make some vaccinations worrisome for youngsters taking high-dose steroids to control asthma or rheumatic diseases and can make other vaccinations vital for children without a spleen, said Dr. McFarland, director of the hospital's immunodeficiency clinic.

Even more serious, she warned, is the risk of sepsis, with high mortality rates from postsplenectomy sepsis. One-half of sepsis cases occur within 2 years of spleen removal, but 3% have been documented 20 years afterward (Br. J. Surg. 1991;78:1031–8).

Steroid Concerns

Dr. McFarland acknowledged that steroids are “important drugs” for controlling inflammation. The problem is that by interfering with cytokine production and lessening immune cell activity, steroids reduce the body's “ability to mount immune response or react to vaccine.”

According to Dr. McFarland, the American Academy of Pediatrics supports giving inactivated virus vaccines to children who are prescribed steroids, but she cautions that immunogenicity is uncertain. Live virus vaccines should be delayed until high-dose steroids are stopped.

If children take a high-dose steroid daily or on alternate days for more than 14 days, doctors should wait 1 month after stopping steroid use before giving vaccines, Dr. McFarland said. She also said that if the dosage period is less than 14 days, live virus vaccines can be given after stopping, but some experts recommend waiting 2 weeks.

AAP recommends inactivated influenza vaccine for patients with asthma. Dr. McFarland said studies have shown similar antibody responses to the influenza vaccine in patients receiving inhaled steroids and short-course oral steroids, when compared with patients not receiving steroids at the time of immunization.

The live varicella zoster virus (VZV) vaccine is not recommended during high-dose steroid use, because vaccine safety is not established in this population. However, Dr. McFarland said a health maintenance organization study found that inhaled steroids given 3 months prior to VZV vaccination were not associated with increased risk of breakthrough disease (Pediatrics 2003; 112:e98-e113), but the study did find increased breakthrough disease after VZV vaccination when oral steroids were given in the 3 months prior.

Postsplenectomy Issues

European studies have shown that about a quarter of physicians do not comply with guidelines for postsplenectomy care, Dr. McFarland said. She could not find any similar studies in the United States.

Although splenectomies in children may be necessary after trauma, she said the operation is being done less often owing to greater recognition of the spleen's importance to immune defense and to newer splenic salvage techniques.

Dr. McFarland urged pneumococcal vaccination for postsplenectomy patients. About two-thirds of sepsis cases have been traced to Streptococcus pneumoniae in this population.

If the regular pneumococcal conjugate vaccine (PCV) series was not given before age 24 months, doctors should give two doses of PCV, she said. She recommended one dose of pneumococcal polysaccharide vaccine 6–8 weeks after PCV, and a second dose 3–5 years afterward.

Postsplenectomy patients also should be vaccinated against meningococcus, according to Dr. McFarland. The new meningococcal conjugate vaccine (MCV4) is preferred for patients aged 11–55; only meningococcal polysaccharide vaccine (MPSV4) is approved for patients aged 2–11. Optimally, vaccinations for the encapsulated bacteria should be given prior to a planned splenectomy.

She suggested giving an extra dose of Haemophilus influenzae type b (Hib) vaccine prior to splenectomy, if possible. Afterward, these children also should receive annual influenza shots, she said.

Daily antibiotic prophylaxis is recommended, especially in the first 2 years after splenectomy.

However, Dr. McFarland said the randomized studies supporting its use were performed in young sickle cell anemia patients with functional asplenia.

Determining when to discontinue daily prophylaxis is difficult, she said, as there are no direct data for children with splenectomies. Physicians should discuss the risks and benefits with their patients. The recommended dosages are 125 mg of penicillin V twice daily in children under age 5 and 250 mg twice daily in children over age 5; some experts use amoxicillin (20 mg/kg daily).

Empiric therapy is another option, often used if daily prophylaxis is discontinued. At the first sign of a fever, the parents administer a dose of oral antibiotics and then bring in the child “pronto” for further evaluation. Dr. McFarland recommended 50 mg/kg of amoxicillin/clavulanate potassium (Augmentin) divided into 2–3 dosages daily or an alternative, possibly a cephalosporin, if the child is allergic to penicillin.

Pneumococcal resistance to penicillin is a concern, she said, and she urged physicians to find out the rate in their community. For sepsis cases, however, she recommended starting with vancomycin and a cephalosporin.

Without a spleen, patients also are at high risk for malaria and other insect-borne infections. Physicians should ask about mosquito and tick exposure and teach parents travel precautions.

Indeed, family education is a priority when caring for a child who has lost a spleen. “You need to give them something written, as you want them to understand the risk of infection,” she said. “And you want to do it more than once.”

Teach Parents About Zoonoses

Many physicians—Dr. McFarland among them—do not have the heart to banish all pets from the home of an immunocompromised child.

“The better you can take care of your animal … the less likely your pet will get sick,” is the message she urged physicians to give to parents of immunocompromised patients. Keeping the animal healthy will help the child stay well.

Dr. McFarland said the U.S. Public Health Service has identified five zoonoses of particular concern that immunocompromised children can pick up from animals: salmonellosis, campylobacteriosis, bacillary angiomatosis (Bartonella henselae, or cat scratch disease), cryptosporidiosis, and toxoplasmosis.

She also summarized the benefits of pet ownership, including decreased loneliness and increased feeling of intimacy and constancy.

The first principle of pet safety, she said, is to buy or adopt a healthy animal, preferably an adult. Young animals are more vulnerable to pathogens. No animal with diarrhea should be handled by the child.

Second, keep the animal healthy by preventing exposure to pathogens. Don't let cats or dogs roam. Fleas and ticks are a concern, as well as exposure to other animals and their feces, and anything else the pet might eat off the street.

Keep the animal inside, and keep the toilet seat down so the pet does not use the fixture as a fountain. Feed the animal well, and make sure it does not get into the garbage.

Third, avoid all contact with feces.

Dr. McFarland offered additional recommendations for patients, including children, who undergo hematopoietic stem cell transplants (MMWR 2000;49[RR10]:1–128). Parents should be advised of the risks, but children don't need to be forced to part with their pets.

Animals should be fed high-quality commercial pet food, according to Dr. McFarland, and at the first suspicion of a pet's illness, the animal should be taken to the vet.

Even with these precautions, some animals are prohibited as pets. She listed all reptiles (with a warning against reptile fomites), ducklings or chicks, and exotic pets, including nonhuman primates.

For more information, including brochures to download, Dr. McFarland recommended referring parents to

www.cdc.gov/healthypets

VERSAILLES, FRANCE — Preliminary data from a new drug safety registry suggest that the combination of etanercept and methotrexate might lead to more serious adverse events than either agent alone in patients with juvenile idiopathic arthritis.

“Some [adverse events] may not be surprising, but I think it is important as increasingly combinations of etanercept and methotrexate are used in severe arthritis,” said Taunton Southwood, M.D.

Speaking on behalf of the British Society for Paediatric and Adolescent Rheumatology Biologics and New Drugs Registry, Dr. Southwood of the University of Birmingham (England) presented the preliminary report at the 12th European Pediatric Rheumatology Congress.

When the data were analyzed, 122 children on etanercept and 30 on methotrexate had been entered into the registry.

Although there is no registration category such as “both drugs,” 28 children were reported to be on both agents.

Dr. Southwood urged caution in interpreting the findings, as they are based on less than a quarter of the data the investigators hope to collect from 12 participating centers, and the cases are not compared with a healthy population. He estimated about 300 children are on etanercept in the United Kingdom.

“It's not a controlled trial as such. It is a safety registry,” he said, adding later with respect to individual adverse events, “We have no factual basis for suggesting they occur any more frequently in the registry patients than in a population of age-matched controls.”

The registry is designed to capture adverse events occurring after the approval of etanercept, which he described as being of “undoubted benefit for treatment of JIA.”

It was established in January 2004, but first began to accumulate substantial amounts of data in the 3 months leading up to August 2005.

Girls comprised about two-thirds of the population analyzed. The children on methotrexate were a mean age of 8 years versus a mean of 12 years for those on etanercept.

Dr. Southwood noted that children in the United Kingdom must be treated with methotrexate before they can start etanercept.

Overall, 197 adverse events were reported in 62 patients. These included 72 (36%) events in 35 patients on etanercept, 62 (31%) events in 20 patients on methotrexate, and 64 (32%) events in 28 patients taking both drugs. Some patients were listed more than once.

“This is an example of how difficult it is to interpret data at this stage,” Dr. Southwood noted.

He categorized serious adverse events related to etanercept as skin conditions, such as eczema, and central nervous system conditions such as panic and anxiety.

Although they were not serious, side effects related to etanercept also included infection (paronychia, skin, respiratory), injection site reactions, rash, and nausea.

Serious adverse events associated with methotrexate included abdominal pain, anemia, abnormal liver function tests, and nausea.

Other related side effects included rash, injection site reactions, eosinophilia, hair loss, and menstrual problems.

The following serious adverse events occurred in children who were receiving both agents: nausea, abnormal liver function tests, hepatomegaly, menstrual problems, pancytopenia, flare, and eczema.

Dr. Southwood said that the combination of agents also was associated with impetigo, paronychia, chicken pox, upper respiratory tract infection, rash, allergic reaction, hair loss, mood, and injection site reactions.

While skin conditions had been reported previously in adults and by a German pediatric register, Dr. Southwood said that the German register had not detected menstrual problems.

VERSAILLES, FRANCE — Preliminary data from a new drug safety registry suggest that the combination of etanercept and methotrexate might lead to more serious adverse events than either agent alone in patients with juvenile idiopathic arthritis.

“Some [adverse events] may not be surprising, but I think it is important as increasingly combinations of etanercept and methotrexate are used in severe arthritis,” said Taunton Southwood, M.D.

Speaking on behalf of the British Society for Paediatric and Adolescent Rheumatology Biologics and New Drugs Registry, Dr. Southwood of the University of Birmingham (England) presented the preliminary report at the 12th European Pediatric Rheumatology Congress.

When the data were analyzed, 122 children on etanercept and 30 on methotrexate had been entered into the registry.

Although there is no registration category such as “both drugs,” 28 children were reported to be on both agents.

Dr. Southwood urged caution in interpreting the findings, as they are based on less than a quarter of the data the investigators hope to collect from 12 participating centers, and the cases are not compared with a healthy population. He estimated about 300 children are on etanercept in the United Kingdom.

“It's not a controlled trial as such. It is a safety registry,” he said, adding later with respect to individual adverse events, “We have no factual basis for suggesting they occur any more frequently in the registry patients than in a population of age-matched controls.”

The registry is designed to capture adverse events occurring after the approval of etanercept, which he described as being of “undoubted benefit for treatment of JIA.”

It was established in January 2004, but first began to accumulate substantial amounts of data in the 3 months leading up to August 2005.

Girls comprised about two-thirds of the population analyzed. The children on methotrexate were a mean age of 8 years versus a mean of 12 years for those on etanercept.

Dr. Southwood noted that children in the United Kingdom must be treated with methotrexate before they can start etanercept.

Overall, 197 adverse events were reported in 62 patients. These included 72 (36%) events in 35 patients on etanercept, 62 (31%) events in 20 patients on methotrexate, and 64 (32%) events in 28 patients taking both drugs. Some patients were listed more than once.

“This is an example of how difficult it is to interpret data at this stage,” Dr. Southwood noted.

He categorized serious adverse events related to etanercept as skin conditions, such as eczema, and central nervous system conditions such as panic and anxiety.

Although they were not serious, side effects related to etanercept also included infection (paronychia, skin, respiratory), injection site reactions, rash, and nausea.

Serious adverse events associated with methotrexate included abdominal pain, anemia, abnormal liver function tests, and nausea.

Other related side effects included rash, injection site reactions, eosinophilia, hair loss, and menstrual problems.

The following serious adverse events occurred in children who were receiving both agents: nausea, abnormal liver function tests, hepatomegaly, menstrual problems, pancytopenia, flare, and eczema.

Dr. Southwood said that the combination of agents also was associated with impetigo, paronychia, chicken pox, upper respiratory tract infection, rash, allergic reaction, hair loss, mood, and injection site reactions.

While skin conditions had been reported previously in adults and by a German pediatric register, Dr. Southwood said that the German register had not detected menstrual problems.

VERSAILLES, FRANCE — Preliminary data from a new drug safety registry suggest that the combination of etanercept and methotrexate might lead to more serious adverse events than either agent alone in patients with juvenile idiopathic arthritis.

“Some [adverse events] may not be surprising, but I think it is important as increasingly combinations of etanercept and methotrexate are used in severe arthritis,” said Taunton Southwood, M.D.

Speaking on behalf of the British Society for Paediatric and Adolescent Rheumatology Biologics and New Drugs Registry, Dr. Southwood of the University of Birmingham (England) presented the preliminary report at the 12th European Pediatric Rheumatology Congress.

When the data were analyzed, 122 children on etanercept and 30 on methotrexate had been entered into the registry.

Although there is no registration category such as “both drugs,” 28 children were reported to be on both agents.

Dr. Southwood urged caution in interpreting the findings, as they are based on less than a quarter of the data the investigators hope to collect from 12 participating centers, and the cases are not compared with a healthy population. He estimated about 300 children are on etanercept in the United Kingdom.

“It's not a controlled trial as such. It is a safety registry,” he said, adding later with respect to individual adverse events, “We have no factual basis for suggesting they occur any more frequently in the registry patients than in a population of age-matched controls.”

The registry is designed to capture adverse events occurring after the approval of etanercept, which he described as being of “undoubted benefit for treatment of JIA.”

It was established in January 2004, but first began to accumulate substantial amounts of data in the 3 months leading up to August 2005.

Girls comprised about two-thirds of the population analyzed. The children on methotrexate were a mean age of 8 years versus a mean of 12 years for those on etanercept.

Dr. Southwood noted that children in the United Kingdom must be treated with methotrexate before they can start etanercept.

Overall, 197 adverse events were reported in 62 patients. These included 72 (36%) events in 35 patients on etanercept, 62 (31%) events in 20 patients on methotrexate, and 64 (32%) events in 28 patients taking both drugs. Some patients were listed more than once.

“This is an example of how difficult it is to interpret data at this stage,” Dr. Southwood noted.

He categorized serious adverse events related to etanercept as skin conditions, such as eczema, and central nervous system conditions such as panic and anxiety.

Although they were not serious, side effects related to etanercept also included infection (paronychia, skin, respiratory), injection site reactions, rash, and nausea.

Serious adverse events associated with methotrexate included abdominal pain, anemia, abnormal liver function tests, and nausea.

Other related side effects included rash, injection site reactions, eosinophilia, hair loss, and menstrual problems.

The following serious adverse events occurred in children who were receiving both agents: nausea, abnormal liver function tests, hepatomegaly, menstrual problems, pancytopenia, flare, and eczema.

Dr. Southwood said that the combination of agents also was associated with impetigo, paronychia, chicken pox, upper respiratory tract infection, rash, allergic reaction, hair loss, mood, and injection site reactions.

While skin conditions had been reported previously in adults and by a German pediatric register, Dr. Southwood said that the German register had not detected menstrual problems.

VERSAILLES, FRANCE — Etanercept was more effective than methotrexate in reducing inflammation and radiographic progression in a retrospective study of juvenile idiopathic arthritis presented at the 12th European Pediatric Rheumatology Congress.

Although 40 children on etanercept (Enbrel) therapy were sicker at baseline, Susan Nielsen, M.D., reported they demonstrated significantly greater improvement at 12 months, compared with 67 children treated with methotrexate.

“Both groups did improve over 1 year, but the etanercept group improved the most,” said Dr. Nielsen of the Juliane Marie Centret, Rigshospitalet, Copenhagen. A member of the national coordinating committee of the Pediatric Rheumatology International Trials Organization (PRINTO), she presented the data on behalf of the Italian Pediatric Rheumatology Study Group.

Nearly 80% of the children on etanercept met the American College of Rheumatology's definition of 30% improvement. About half reached the standard for 70% improvement.

At 1 year, fewer than half of the children on methotrexate satisfied the definition of 30% improvement; roughly a third achieved 70% improvement, according to Dr. Nielsen's presentation.

The investigators mined an Italian registry of patients treated with etanercept from March 1999 to January 2004. They compared the children selected with a historical control group of patients who received methotrexate as monotherapy from September 1989 to October 2003.

All patients included in the analysis were required to have had a wrist x-ray at baseline and at 1 year. These imaging results were used to measure radiographic progression according to Poznanski scores.

Coinvestigator Angelo Ravelli, M.D., of Istituto G. Gaslini in Genoa, Italy, told this newspaper that the Poznanski scoring was important to the study because it provided a reliable way to measure changes in children who were also growing during the course of the study.

“Children grow, so the appearance of bone and width of the joints varies with age,” he said. “Just looking at the film of children of different ages you can't estimate rightly the amount of damage. … You need a normal standard.”

Indeed, the difference in average changes in Poznanski scores proved statistically significant. Scores fell by -0.023 in the children on methotrexate, but rose by 0.389 in the children on etanercept. At baseline, the mean scores were 1.25 for the methotrexate group and −2.24 in the etanercept cohort.

Other statistically significant changes included greater improvements on a parental global visual analog scale (−4.8 with etanercept vs. −1.4 with methotrexate), in the Childhood Health Assessment Questionnaire (−0.9 vs. −0.2), in the number of active joints (−8.0 vs. −4.0), and in the number of joints with limitation of motion (−6.0 vs. −2.0).

At the start of treatment, a number of measures suggested that the etanercept patients had worse disease. They had been sick longer on average: 4.9 years vs. 2.2 years for the methotrexate group. Their parental global assessment scores were higher (5.87 vs. 3.98), as were their Childhood Health Assessment Questionnaire scores (1.4 vs. 0.78). The etanercept patients also had more joints with restricted motion (13.3 vs. 9.2).

The investigators acknowledged that longer duration of disease might offer a partial explanation for why the etanercept patients showed less radiographic progression. They called for a controlled clinical trial to compare the two drugs.

Observational studies don't prove anything, Dr. Nielsen said. “But we think etanercept is superior to methotrexate in suppressing inflammation and may be superior in reducing radiographic progression.”

“If the patients with etanercept were worse than the patients with methotrexate, we think the effect is bigger,” added senior scientist Nicola Ruperto, M.D., of PRINTO and Istituto G. Gaslini in an interview after the presentation.

VERSAILLES, FRANCE — Etanercept was more effective than methotrexate in reducing inflammation and radiographic progression in a retrospective study of juvenile idiopathic arthritis presented at the 12th European Pediatric Rheumatology Congress.

Although 40 children on etanercept (Enbrel) therapy were sicker at baseline, Susan Nielsen, M.D., reported they demonstrated significantly greater improvement at 12 months, compared with 67 children treated with methotrexate.

“Both groups did improve over 1 year, but the etanercept group improved the most,” said Dr. Nielsen of the Juliane Marie Centret, Rigshospitalet, Copenhagen. A member of the national coordinating committee of the Pediatric Rheumatology International Trials Organization (PRINTO), she presented the data on behalf of the Italian Pediatric Rheumatology Study Group.

Nearly 80% of the children on etanercept met the American College of Rheumatology's definition of 30% improvement. About half reached the standard for 70% improvement.

At 1 year, fewer than half of the children on methotrexate satisfied the definition of 30% improvement; roughly a third achieved 70% improvement, according to Dr. Nielsen's presentation.

The investigators mined an Italian registry of patients treated with etanercept from March 1999 to January 2004. They compared the children selected with a historical control group of patients who received methotrexate as monotherapy from September 1989 to October 2003.

All patients included in the analysis were required to have had a wrist x-ray at baseline and at 1 year. These imaging results were used to measure radiographic progression according to Poznanski scores.

Coinvestigator Angelo Ravelli, M.D., of Istituto G. Gaslini in Genoa, Italy, told this newspaper that the Poznanski scoring was important to the study because it provided a reliable way to measure changes in children who were also growing during the course of the study.

“Children grow, so the appearance of bone and width of the joints varies with age,” he said. “Just looking at the film of children of different ages you can't estimate rightly the amount of damage. … You need a normal standard.”

Indeed, the difference in average changes in Poznanski scores proved statistically significant. Scores fell by -0.023 in the children on methotrexate, but rose by 0.389 in the children on etanercept. At baseline, the mean scores were 1.25 for the methotrexate group and −2.24 in the etanercept cohort.

Other statistically significant changes included greater improvements on a parental global visual analog scale (−4.8 with etanercept vs. −1.4 with methotrexate), in the Childhood Health Assessment Questionnaire (−0.9 vs. −0.2), in the number of active joints (−8.0 vs. −4.0), and in the number of joints with limitation of motion (−6.0 vs. −2.0).

At the start of treatment, a number of measures suggested that the etanercept patients had worse disease. They had been sick longer on average: 4.9 years vs. 2.2 years for the methotrexate group. Their parental global assessment scores were higher (5.87 vs. 3.98), as were their Childhood Health Assessment Questionnaire scores (1.4 vs. 0.78). The etanercept patients also had more joints with restricted motion (13.3 vs. 9.2).

The investigators acknowledged that longer duration of disease might offer a partial explanation for why the etanercept patients showed less radiographic progression. They called for a controlled clinical trial to compare the two drugs.

Observational studies don't prove anything, Dr. Nielsen said. “But we think etanercept is superior to methotrexate in suppressing inflammation and may be superior in reducing radiographic progression.”

“If the patients with etanercept were worse than the patients with methotrexate, we think the effect is bigger,” added senior scientist Nicola Ruperto, M.D., of PRINTO and Istituto G. Gaslini in an interview after the presentation.

VERSAILLES, FRANCE — Etanercept was more effective than methotrexate in reducing inflammation and radiographic progression in a retrospective study of juvenile idiopathic arthritis presented at the 12th European Pediatric Rheumatology Congress.

Although 40 children on etanercept (Enbrel) therapy were sicker at baseline, Susan Nielsen, M.D., reported they demonstrated significantly greater improvement at 12 months, compared with 67 children treated with methotrexate.

“Both groups did improve over 1 year, but the etanercept group improved the most,” said Dr. Nielsen of the Juliane Marie Centret, Rigshospitalet, Copenhagen. A member of the national coordinating committee of the Pediatric Rheumatology International Trials Organization (PRINTO), she presented the data on behalf of the Italian Pediatric Rheumatology Study Group.

Nearly 80% of the children on etanercept met the American College of Rheumatology's definition of 30% improvement. About half reached the standard for 70% improvement.

At 1 year, fewer than half of the children on methotrexate satisfied the definition of 30% improvement; roughly a third achieved 70% improvement, according to Dr. Nielsen's presentation.

The investigators mined an Italian registry of patients treated with etanercept from March 1999 to January 2004. They compared the children selected with a historical control group of patients who received methotrexate as monotherapy from September 1989 to October 2003.

All patients included in the analysis were required to have had a wrist x-ray at baseline and at 1 year. These imaging results were used to measure radiographic progression according to Poznanski scores.

Coinvestigator Angelo Ravelli, M.D., of Istituto G. Gaslini in Genoa, Italy, told this newspaper that the Poznanski scoring was important to the study because it provided a reliable way to measure changes in children who were also growing during the course of the study.

“Children grow, so the appearance of bone and width of the joints varies with age,” he said. “Just looking at the film of children of different ages you can't estimate rightly the amount of damage. … You need a normal standard.”

Indeed, the difference in average changes in Poznanski scores proved statistically significant. Scores fell by -0.023 in the children on methotrexate, but rose by 0.389 in the children on etanercept. At baseline, the mean scores were 1.25 for the methotrexate group and −2.24 in the etanercept cohort.

Other statistically significant changes included greater improvements on a parental global visual analog scale (−4.8 with etanercept vs. −1.4 with methotrexate), in the Childhood Health Assessment Questionnaire (−0.9 vs. −0.2), in the number of active joints (−8.0 vs. −4.0), and in the number of joints with limitation of motion (−6.0 vs. −2.0).

At the start of treatment, a number of measures suggested that the etanercept patients had worse disease. They had been sick longer on average: 4.9 years vs. 2.2 years for the methotrexate group. Their parental global assessment scores were higher (5.87 vs. 3.98), as were their Childhood Health Assessment Questionnaire scores (1.4 vs. 0.78). The etanercept patients also had more joints with restricted motion (13.3 vs. 9.2).

The investigators acknowledged that longer duration of disease might offer a partial explanation for why the etanercept patients showed less radiographic progression. They called for a controlled clinical trial to compare the two drugs.

Observational studies don't prove anything, Dr. Nielsen said. “But we think etanercept is superior to methotrexate in suppressing inflammation and may be superior in reducing radiographic progression.”

“If the patients with etanercept were worse than the patients with methotrexate, we think the effect is bigger,” added senior scientist Nicola Ruperto, M.D., of PRINTO and Istituto G. Gaslini in an interview after the presentation.