The majority of JRA patients who developed a disease flare in part 2 and reintroduced ENBREL® treatment up to 4 months after discontinuation re-responded to ENBREL® therapy in open-label studies. Most of the responding patients who continued ENBREL® therapy without interruption have maintained responses for up to 48 months.

Studies have not been done in patients with polyarticular-course JRA to assess the effects of continued ENBREL® therapy in patients who do not respond within 3 months of initiating ENBREL® therapy, or to assess the combination of ENBREL® with methotrexate.

Psoriatic Arthritis

The safety and efficacy of ENBREL® were assessed in a randomized, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis. Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in one or more of the following forms: (1) distal interphalangeal (DIP) involvement (N = 104); (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis; N = 173); (3) arthritis mutilans (N = 3); (4) asymmetric psoriatic arthritis (N = 81); or (5) ankylosing spondylitis-like (N = 7). Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter. Patients on MTX therapy at enrollment (stable for ≥ 2 months) could continue at a stable dose of ≤ 25 mg/week MTX. Doses of 25 mg ENBREL® or placebo were administered SC twice a week during the initial 6-month double-blind period of the study. Patients continued to receive blinded therapy in an up to 6-month maintenance period until all patients had completed the controlled period. Following this, patients received open-label 25 mg ENBREL® twice a week in a 12-month extension period.

Compared to placebo, treatment with ENBREL® resulted in significant improvements in measures of disease activity (Table 6).

Table 6:
Components of Disease Activity in Psoriatic Arthritis

Bookmark this page: