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Adalimumab, etanercept safe, efficacious in long-term treatment of JRA, researchers report

Monday, November 12 2007 | Comments

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What's This? Both adalimumab and etanercept appear to be safe and highly efficacious in the long-term treatment of patients with juvenile rheumatoid arthritis (JRA), according to data from 2 studies.

Dr. Daniel Lovell, a professor of pediatrics at Cincinnati Children's Hospital Medical Center, presented data from a Phase III double-blind withdrawal trial in which 171 patients aged 4 to 17 years with polyarticular JRA were administered adalimumab 24 mg/m2 (maximum, 40 mg) every other week as part of a 16-week open-label period, after which the patients who achieved an American College of Rheumatology Pediatric (ACR Pedi) 30 response were stratified by methotrexate use and were randomized to receive adalimumab or placebo every other week for 32 weeks or until disease flare (primary endpoint; defined as a >=30% increase in 3 of 6 core criteria). After this phase, the patients could choose to enter an open-label extension study for the remainder of 2 years.

At 16 weeks, 84% of the patients achieved an ACR Pedi 30 response, 77% achieved an ACR Pedi 50 response, 58% achieved an ACR Pedi 70 response and 27% achieved an ACR Pedi 90 response. Response rates were maintained among the 128 patients who entered the open-label extension; specifically, 94% achieved an ACR Pedi 30 response, 93% achieved an ACR Pedi 50 response, 81% achieved an ACR Pedi 70, and 60% achieved an ACR Pedi 90 response, regardless of methotrexate status.

Safety data were similar to that of previous study periods, and the benefit/risk profile of treatment was favorable, Dr. Lovell noted. (Abstract 681.)

Dr. Andreas Reiff, head of the Keck School of Medicine's division of rheumatology, presented 8-year data from an open-label extension study of a double-blind, randomized controlled trial of etanercept.

A total of 69 patients with JRA were enrolled in the original randomized phase of the study, of whom 58 (84%) participated in the open-label extension, for a total of 318 patient-years of etanercept exposure. Of these, 42 patients (61%) continued into the fourth year of continuous drug exposure and 26 patients (38%) entered into the eighth year of continuous therapy.

The most common reason for withdrawal from the randomized or open-label phases of the study was patient/guardian refusal (n=10; 14.5%), "probably because they were feeling well," Dr. Reiff remarked. Nine patients (13%) withdrew because of suboptimal response, 5 (7.2%) withdrew because of adverse events, and 5 (7.2%) withdrew because of physician decision.

The overall rate of serious adverse events did not increase with long-term exposure to etanercept, and safety data at 8 years were similar to that obtained at 4 years, according to Dr. Reiff. No cases of systemic lupus erythematosus, demyelinating disorders, tuberculosis or malignancies were reported.

In an efficacy analysis at 7 years that was calculated among the 58 patients who participated in the open-label extension, 90% of the patients achieved an ACR30 response, 90% achieved an ACR50 response, 86% achieved an ACR70 response, 67% achieved an ACR90 response, and 29% achieved an ACR100 response. (Abstract 682.)

This information concerns a use that has not been approved by the Food and Drug Administration.

By Hunter Kaller

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