In Study IV, less radiographic progression (TSS) was observed with ENBREL® in combination with MTX compared with ENBREL® alone or MTX alone at month 12 (Table 5). In the MTX treatment group 55% of patients experienced no radiographic progression (TSS change ≤ 0.0) at 12 months compared to 63% and 76% in the ENBREL® alone and the ENBREL®/MTX combination treatment groups, respectively.

Table 5:
Mean Radiographic Change in Study IV at 12 Months
(95% Confidence Interval)

Once Weekly Dosing

The safety and efficacy of 50 mg ENBREL® (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA. Fifty-three patients received placebo, 214 patients received 50 mg ENBREL® once weekly, and 153 patients received 25 mg ENBREL® twice weekly. The safety and efficacy profiles of the two ENBREL® treatment groups were similar.

Polyarticular-Course Juvenile Rheumatoid Arthritis (JRA)

The safety and efficacy of ENBREL® were assessed in a two-part study in 69 children with polyarticular-course JRA who had a variety of JRA onset types. Patients ages 4 to 17 years with moderately to severely active polyarticular-course JRA refractory to or intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (≤ 0.2 mg/kg/day or 10 mg maximum). In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) ENBREL® SC twice weekly. In part 2, patients with a clinical response at day 90 were randomized to remain on ENBREL® or receive placebo for four months and assessed for disease flare. Responses were measured using the JRA Definition of Improvement (DOI),³ defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of the six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and ESR. Disease flare was defined as a ≥ 30% worsening in three of the six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.

In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2. In part 2, 6 of 25 (24%) patients remaining on ENBREL® experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p = 0.007). From the start of part 2, the median time to flare was ≥ 116 days for patients who received ENBREL® and 28 days for patients who received placebo. Each component of the JRA core set criteria worsened in the arm that received placebo and remained stable or improved in the arm that continued on ENBREL®. The data suggested the possibility of a higher flare rate among those patients with a higher baseline ESR. Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on ENBREL® continued to improve from month 3 through month 7, while those who received placebo did not improve.

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