sion (TSS change ≤ 0.0) at 12 months compared to 63% and 76% in theetanercept alone and the etanercept/MTX combination treatment groups, respectively.
Table 10. Mean Radiographic Change in Study IV at 12 Months
(95% Confidence Interval)
MTX
(N=212)*
Etanercept
(N=212)*
Etanercept/MTX
(N=218)*
Total Sharp Score (TSS)
Erosion Score (ES)
Joint Space Narrowing (JSN) Score
2.80
(1.08, 4.51)
0.52a
(-0.10, 1.15)
1.68
(0.61, 2.74)
0.21a
(-0.20, 0.61)
1.12
(0.34, 1.90)
0.32
(0.00, 0.63)
-0.54b, c
(-1.00, -0.07)
-0.30b
(-0.65, 0.04)
-0.23b, c
(-0.45, -0.02) * Analyzed radiographic ITT population.
a p < 0.05 for comparison of etanercept vs MTX.
b p < 0.05 for comparison of etanercept/MTX vs MTX.
c p < 0.05 for comparison of etanercept/MTX vs etanercept.
Once Weekly Dosing
The safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly were eva luated in adouble-blind, placebo-controlled study of 420 patients with active RA. Fifty-three patients received placebo, 214patients received 50 mg etanercept once weekly, and 153 patients received 25 mg etanercept twice weekly. The safetyand efficacy profiles of the two etanercept treatment groups were similar.
14.2 Polyarticular Juvenile Idiopathic Arthritis (JIA)
The safety and efficacy of etanercept were assessed in a 2-part study in 69 children with polyarticular JIA who had avariety of JIA onset types. Patients ages 2 to 17 years with moderately to severely active polyarticular JIA refractoryto or intolerant of MTX were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatorydrug and/or prednisone (≤ 0.2 mg/kg/day or 10 mg maximum). In part 1, all patients received 0.4 mg/kg (maximum25 mg per dose) etanercept SC twice weekly. In part 2, patients with a clinical response at day 90 were randomized toremain on etanercept or receive placebo for 4 months and assessed for disease flare.
Responses were measured usingthe JIA Definition of Improvement (DOI), 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 JIAcore 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 etanercept experienced a disease flare compared to 20 of 26 (77%) patients receivingplacebo (p = 0.007). From the start of part 2, the median time to flare was ≥ 116 days for patients who receivedetanercept and 28 days for patients who received placebo. Each component of the JIA core set criteria worsened in thearm that received placebo and remained stable or improved in the arm that continued on etanercept.
The datasuggested the possibility of a higher flare rate among those patients with a higher baseline ESR. Of patients whodemonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on
etanercept continued to improve from month 3 through month 7, while those who received placebo did not improve.
The majority of JIA patients who developed a disease fla |
