tanercept, relative to placebo, as measured by percentages ofpatients achieving improvements in the Psoriasis Area and Severity Index (PASI). Responses increased over time, andat 6 months, the proportions of patients achieving a 50% or 75% improvement in the PASI were 47% and 23%,respectively, in the etanercept group (N=66), compared to 18% and 3%, respectively, in the placebo group (N=62).
Responses were similar in patients who were or were not receiving concomitant MTX therapy at baseline.
Radiographic Response
Radiographic changes were also assessed in the PsA study. Radiographs of hands and wrists were obtained at baselineand months 6, 12, and 24. A modified Total Sharp Score (TSS), which included distal interphalangeal joints (ie, notidentical to the modified TSS used for RA) was used by readers blinded to treatment group to assess the radiographs.
Some radiographic features specific to PsA (eg, pencil-and-cup deformity, joint space widening, gross osteolysis, andankylosis) were included in the scoring system, but others (eg, phalangeal tuft resorption, juxta-articular and shaftperiostitis) were not.
Most patients showed little or no change in the modified TSS during this 24-month study (median change of 0 in bothpatients who initially received etanercept or placebo). More placebo-treated patients experienced larger magnitudes ofradiographic worsening (increased TSS) compared to etanercept treatment during the controlled period of the study.
At 12 months, in an exploratory analysis, 12% (12 of 104) of placebo patients compared to none of the 101
etanercept-treated patients had increases of 3 points or more in TSS. Inhibition of radiographic progression was
maintained in patients who continued on etanercept during the second year. Of the patients with 1-year and 2-year
x-rays, 3% (2 of 71) had increases of 3 points or more in TSS at 1 and 2 years.
Physical Function Response
In the PsA study, physical function and disability were assessed using the HAQ Disability Index (HAQ-DI) and theSF-36 Health Survey. Patients treated with 25 mg etanercept twice weekly showed greater improvement from baselinein the HAQ-DI score (mean decreases of 54% at both months 3 and 6) in comparison to placebo (mean decreases of6% at both months 3 and 6) (p < 0.001). At months 3 and 6, patients treated with etanercept showed greater improvement from baseline in the SF-36 physical component summary score compared to patients treated withplacebo, and no worsening in the SF-36 mental component summary score. Improvements in physical function and
disability measures were maintained for up to 2 years through the open-label portion of the study.
14.4 Ankylosing Spondylitis
The safety and efficacy of etanercept were assessed in a randomized, double-blind, placebo-controlled study in 277patients with active AS. Patients were between 18 and 70 years of age and had AS as defined by the modified NewYork Criteria for Ankylosing Spondylitis. Patients were to have evidence of active disease based on values of ≥ 30 ona 0-100 unit Visual Analog Scale (VAS) for the average of morning stiffness duration and intensity, and two of thefollowing three other parameters: a) patient global assessment, b) average of nocturnal and total back pain, and c) theaverage score on the Bath Ankylosing Spondylitis Functional Index (BASFI). Patients with complete ankylosis of thespine were excluded from study participation. Patients taking hydroxychloroquine, sulfasalazine |
