hem had no progression of structural damage. Patients originally treated with MTX had further reduction in radiographic progression once they began treatment with ENBREL®.
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) *
Analyzed radiographic ITT population.
†
p < 0.05 for comparison of ENBREL ® vs MTX.
‡
p < 0.05 for comparison of ENBREL ® /MTX vs MTX.
§
p < 0.05 for comparison of ENBREL ®/MTX vs ENBREL ®.
MTX
(N = 212)* ENBREL®
(N = 212)* ENBREL®/MTX
(N = 218)*
Total Sharp Scores (TSS) 2.80
(1.08, 4.51) 0.52† (-0.10, 1.15) -0.54‡§ (-1.00, -0.07)
Erosion Score (ES) 1.68
(0.61, 2.74) 0.21†
(-0.20, 0.61) -0.30‡
(-0.65, 0.04)
Joint Space Narrowing Score (JSN) 1.12
(0.34, 1.90) 0.32
(0.00, 0.63) -0.23ठ(-0.45, -0.02)
Once Weekly Dosing
The safety and efficacy of 50 mg ENBREL® (two 25 mg SC injections) administered once weekly were eva luated 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 Idiopathic Arthritis (JIA)
The safety and efficacy of ENBREL® were assessed in a two-part study in 69 children with polyarticular-course JIA who had a variety of JIA onset types. Patients ages 4 to 17 years with moderately to severely active polyarticular-course JIA 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 JIA 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 JIA 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 JIA core set criteria and ≥ 30% improvement in not more than one of the six JIA 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 JIA core set criteria worsened |
