≤ 25 mg/week methotrexate. Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months. At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years. Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC). Results are summarised in the table below. Responses of patients with psoriatic arthritis in a placebo-controlled trial a: 25 mg etanercept SC twice weekly b: p c:
p Among patients with psoriatic arthritis 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. Etanercept was significantly better than placebo in all measures of disease activity (p similar with and without concomitant methotrexate therapy. Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ. The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p Radiographic changes were assessed in the psoriatic arthritis study.
Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24. The modified TSS at 12 months is presented in the table below. In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001). The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year. The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Mean (SE) annualized change from baseline in total sharp score Time Placebo (n = 104) Etanercept(n = 101) Month 12 1.00 (0.29) -0.03 (0.09) a SE = standard error. a. p = 0.0001. Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years. There is insufficient evidence of the efficacy of etanercept in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
21 Percent of Patients Psoriatic Arthritis Response Placebo n = 104 Etanercepta n = 101 ACR 20 Month 3 15 59b Month 6 13 50b ACR 50 Month 3 4 38b Month 6 4 37b ACR 70 Month 3 0 11b Month 6 1 9c PsARC Month 3 31 72b Month 6 23 70b