Enbrel

[etanercept]

Study IV evaluated 682 adult patients with active RA of 6 months to 20 years duration (mean of 7 years) who had an inadequate response to at least one DMARD other than MTX. Forty-three percent of patients had previously received MTX a mean of two years prior to the trial at a mean dose of 12.9 mg. Patients were excluded from this study if MTX had been discontinued for lack of efficacy or for safety considerations. The patient baseline characteristics were similar to those of patients in Study I (Table 3). Patients were randomized to MTX alone (7.5 to 20 mg weekly, dose escalated as described for Study III; median dose 20 mg), ENBRELŽ alone (25 mg twice weekly), or the combination of ENBRELŽ and MTX initiated concurrently (at the same doses as above). The study evaluated ACR response, Sharp radiographic score and safety.

Clinical Response

A higher percentage of patients treated with ENBRELŽ and ENBRELŽ in combination with MTX achieved ACR 20, ACR 50 and ACR 70 responses and Major Clinical Responses than in the comparison groups. The results of Studies I, II, and III are summarized in Table 1. The results of Study IV are summarized in Table 2.
Table 1:
ACR Responses in Placebo- and Active-Controlled Trials
(Percent of Patients)
Placebo Controlled Active Controlled
Study I Study II Study III
Placebo ENBRELŽa MTX/
Placebo
MTX/
ENBRELŽa
MTX ENBRELŽa
Response N = 80 N = 78 N = 30 N = 59 N = 217 N = 207
ACR 20
Month 3 23% 62%b 33% 66%b 56% 62%
Month 6 11% 59%b 27% 71%b 58% 65%
Month 12 NA NA NA NA 65% 72%
ACR 50
Month 3 8% 41%b 0% 42%b 24% 29%
Month 6 5% 40%b 3% 39%b 32% 40%
Month 12 NA NA NA NA 43% 49%
ACR 70
Month 3 4% 15%b 0% 15%b 7% 13%c
Month 6 1% 15%b 0% 15%b 14% 21%c
Month 12 NA NA NA NA 22% 25%
a 25 mg ENBRELŽ SC twice weekly.
b p < 0.01, ENBRELŽ vs. placebo.
c p < 0.05, ENBRELŽ vs. MTX.

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Table 2:
Study IV Clinical Efficacy Results: Comparison of MTX vs ENBRELŽ vs ENBRELŽ in Combination with MTX in Patients with RA of 6 Months to 20 years Duration
(Percent of Patients)
Endpoint
MTX
(N = 228)
ENBRELŽ
(N = 223)
ENBRELŽ/MTX
(N = 231)
ACR Na, b
Month 12 40 47 63c
ACR 20
Month 12 59% 66% 75%c
ACR 50
Month 12 36% 43% 63%c
ACR 70
Month 12 17% 22% 40%c
Major Clinical Responsed 6% 10% 24%c

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