re in part 2 and reintroduced etanercept treatment up to4 months after discontinuation re-responded to etanercept therapy in open-label studies. Most of the respondingpatients who continued etanercept therapy without interruption have maintained responses for up to 48 months.Studies have not been done in patients with polyarticular JIA to assess the effects of continued etanercept therapy inpatients who do not respond within 3 months of initiating etanercept therapy, or to assess the combination ofetanercept with MTX.
14.3 Psoriatic Arthritis
The safety and efficacy of etanercept were assessed in a randomized, double-blind, placebo-controlled study in 205patients with PsA. Patients were between 18 and 70 years of age and had active PsA (≥ 3 swollen joints and ≥ 3 tenderjoints) in one or more of the following forms: (1) distal interphalangeal (DIP) involvement (N=104); (2) polyarticulararthritis (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 witha qualifying target lesion ≥ 2 cm in diameter. Patients on MTX therapy at enrollment (stable for ≥ 2 months) couldcontinue at a stable dose of ≤ 25 mg/week MTX. Doses of 25 mg etanercept or placebo were administered SC twice aweek during the initial 6-month double-blind period of the study. Patients continued to receive blinded therapy in anup to 6-month maintenance period until all patients had completed the controlled period. Following this, patientsreceived open-label 25 mg etanercept twice a week in a 12-month extension period.
Compared to placebo, treatment with etanercept resulted in significant improvements in measures of disease activity(Table 11).
Table 11. Components of Disease Activity in Psoriatic Arthritis
Placebo Etanercepta
N=104 N=101
Parameter (median) Baseline 6 Months Baseline 6 Months
Number of tender jointsb 17.0 13.0 18.0 5.0
Number of swollen jointsc 12.5 9.5 13.0 5.0
Physician global assessmentd 3.0 3.0 3.0 1.0
Patient global assessmentd 3.0 3.0 3.0 1.0
Morning stiffness (minutes) 60 60 60 15
Paind 3.0 3.0 3.0 1.0
Disability indexe 1.0 0.9 1.1 0.3
CRP (mg/dL)f 1.1 1.1 1.6 0.2 a p < 0.001 for all comparisons between etanercept and placebo at 6 months.
b Scale 0-78.
c Scale 0-76.
d Likert scale: 0=best; 5=worst.
e Health Assessment Questionnaire: 0=best; 3=worst; includes eight categories: dressing and grooming, arising,
eating, walking, hygiene, reach, grip, and activities.
f Normal range: 0-0.79 mg/dL.
Among patients with PsA who received etanercept, the clinical responses were apparent at the time of the first visit(4 weeks) and were maintained through 6 months of therapy. Responses were similar in patients who were or were notreceiving concomitant MTX therapy at baseline. At 6 months, the ACR 20/50/70 responses were achieved by 50%,37%, and 9%, respectively, of patients receiving etanercept, compared to 13%, 4%, and 1%, respectively, of patientsreceiving placebo. Similar responses were seen in patients with each of the subtypes of PsA, although few patientswere enrolled with the arthritis mutilans and ankylosing spondylitis-like subtypes. The results of this study weresimilar to those seen in an earlier single-center, randomized, placebo-controlled study of 60 patients with PsA.
The skin lesions of psoriasis were also improved with e |
