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.
The majority of JIA 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 JIA 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 *
p < 0.001 for all comparisons between ENBREL ® and placebo at 6 months.
†
Scale 0 – 78.
‡
Scale 0 – 76.
§
Likert scale; 0 = best, 5 = worst.
¶
Health Assessment Questionnaire 1; 0 = best, 3 = worst; includes eight categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
#
Normal range: 0 – 0.79 mg/dL.
Placebo
N = 104 ENBREL®*
N = 101
Parameter (median) Baseline 6 Months Baseline 6 Months
Number of tender joints† 17.0 13.0 18.0 5.0
Number of swollen joints‡ 12.5 9.5 13.0 5.0
Physician global assessment§ 3.0 3.0 3.0 1.0
Patient global assessment§ 3.0 3.0 3.0 1.0
Morning stiffness (minutes) 60 60 60 15
Pain§ 3.0 3.0 3.0 1.0
Disability index¶ 1.0 0.9 1.1 0.3
CRP (mg/dL)# 1.1 1.1 1.6 0.2
Among patients with psoriatic arthritis who received ENBREL®, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therap |
