Etanercept is a soluble receptor TNF-a antagonist currently approved for treatment of RA, JA, PsA, AS and psoriasis. It typically is given as 25 mg subcutaneously twice a week or 50 mg once a week. Approval of etanercept in PsA is based on two placebo-controlled trials. In a single-center trial, PsA patients (n = 60) were randomized to etanercept or to placebo. Nearly one-half (47%) of these patients were receiving a concomitant stable dose of MTX (Mease et al. 2000). Patients had on average a 20-year history of psoriasis and a 15-year history of inflammatory arthritis. In the 3-month placebo-controlled phase of the study, 87 % of patients receiving etanercept and 23% of patients receiving placebo improved according to the Psoriatic Arthritis Response Criteria (PsARC) (p<0.0001). In addition, 73% of
patients receiving etanercept and 13% of patients receiving placebo improved according to the composite ACR 20 response criteria, which are a standard for assessing treatment response in rheumatoid arthritis (p = 0.015). Skin lesions also improved significantly. Randomization in this trial was stratified according to use of MTX, utilized by nearly half of the patients. Concomitant use of MTX did not affect the results, suggesting that etanercept can be effective as monotherapy or in combination with a traditional DMARD.
In a larger, multicenter study of similar design (n = 205), patients received either etanercept or placebo. Concomitant MTX was used by 42% of patients (Mease et al. 2004b). Fifty-nine percent of etanercept patients and 15% of placebo patients achieved an ACR 20 response at 3 months (Fig. 10.4a). PsARC response was observed in 72% and 31 %, respectively. The treatment group showed significant changes in all individual measures of the composite criteria and significant improvements in measures of quality of life (SF-36, DLQI) and function (HAQ). At baseline 66 patients in the etanercept group and 62 in the placebo group had plaque psoriasis that involved at least 3 % of their body surface area, and thus were eligible for PASI scoring. At week 24, 23% of the etanercept group achieved a PASI 75 response as compared to 3% in the placebo group (p = 0.001) (Fig. 10.4b); 47% and 18% achieved a PASI 50 response respectively (p<0.001). Radiographs showed inhibition of disease progression, the first demonstration of such an effect in PsA. After 48 weeks, there was no worsening of Total Sharp Score (TSS) in the active treatment group: a significant benefit compared to placebo, where worsening was observed (Mease et al. 2004, 2004) (Fig. 10.4c). As in the previous trial, background treatment with MTX did not affect outcome. Two year extension data from this trial ha been reported and shows persistent efficacy and safety (Mease et al. 2006b).
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