Etanercept Shown Superior to Methotrexate in JIA

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.