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Title: Etanercept Plus Methotrexate Effective Therapy for Juvenile Idiopathic Arthritis: Presented at ACR

"Etanercept Plus Methotrexate Effective Therapy for Juvenile Idiopathic Arthritis: Presented at ACR"

By Bruce Sylvester SAN DIEGO, CA -- November 22, 2005 -- Etanercept as monotherapy or in combination with methotrexate resulted in significant improvements in the signs and symptoms of juvenile idiopathic arthritis (JIA) compared with methotrexate monotherapy, researchers reported here at the American College of Rheumatology Annual Scientific Meeting (ACR). Etanercept is approved for treatment of polyarticular juvenile arthritis, but research in patients with rheumatoid arthritis has shown its superiority in combination with methotrexate compared with methotrexate alone. Until now, no study has evaluated the efficacy and safety of etanercept plus methotrexate in JIA, said Gerd Horneff, MD, rheumatologist, Asklepions Clinic, Sakt Augustin, Germany, during his presentation on November 17[^th. His research team therefore compared the combination to single etanercept in a cohort of patients with JIA.

The study enrolled 354 pediatric patients with JIA who received etanercept in addition to their pre-existing methotrexate therapy. A total of 81 subjects received etanercept monotherapy.

The 2 treatment arms had similar distribution of JIA subtypes.

At the start of etanercept treatment, subjects on combination treatment had a higher number of active and tender joints, longer duration of morning stiffness, higher physician's or patient's assessment of disease severity evaluated by Visual Analog Scale, and higher serum levels of C reactive protein compared with the etanercept monotherapy group.

The investigators found a higher rate of ongoing steroid use among subjects in the combination therapy group than those in the monotherapy group (P < .001).

Using the American College of Rheumatology - Juvenile Rheumatoid Arthritis criteria to evaluate for therapeutic efficacy, the researchers found that the number of subjects achieving a 30%, 50% or 70% response after 6 and 12 months of treatment was higher in the combination treatment group.

There were 18 discontinuations (22%) in the etanercept monotherapy group, caused by inefficacy in 10 subjects, adverse events in 6 subjects, and remission in 2 subjects.

There were 55 discontinuations (18%) in the combination group, caused by inefficacy in 30 subjects, adverse events in 20 subjects and, remission in 15 subjects.

Methotrexate was discontinued in 7% of patients, largely due to the, "remarkable therapeutic response of etanercept," the authors state in their abstract.

Corticosteroids were discontinued more often in the combination group.

During a total of 600 patient-years of treatment, the investigators recorded 18 adverse events in 13 patients in the etanercept group and 100 adverse events in 61 patients of the combination group.

Elevations in liver enzymes appeared only in the methotrexate-treated patients. "All but 1 patient in whom cytopenia was noted belonged to the combination group," the authors reported.

Frequency of infections, skin-reactions, or other adverse events did not vary between treatment groups.

Discontinuation due to treatment failure was lower in the combination group. Tolerability of treatment was excellent in both groups, Dr. Horneff said.

"Combination therapy appears to be a reasonable course of therapy for this JIA patient population, " he concluded.

"There were more remissions in the etanercept/methotrexate group," he added. "Combination therapy also produced a significantly higher rate of discontinuation of corticosteroid use."

[Presentation title: Combination Therapy With Etanercept and Methotrexate Compared to Etanercept Monotherapy in Patients With Juvenile Idiopathic Arthritis. Abstract 1955]

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