y. Responses were similar in patients who were or were not receiving concomitant methotrexate therapy at baseline. At 6 months, the ACR 20/50/70 responses were achieved by 50%, 37%, and 9%, respectively, of patients receiving ENBREL®, compared to 13%, 4%, and 1%, respectively, of patients receiving placebo. Similar responses were seen in patients with each of the subtypes of psoriatic arthritis, although few patients were enrolled with the arthritis mutilans and ankylosing spondylitis-like subtypes. The results of this study were similar to those seen in an earlier single-center, randomized, placebo-controlled study of 60 patients with psoriatic arthritis.
The skin lesions of psoriasis were also improved with ENBREL®, relative to placebo, as measured by percentages of patients achieving improvements in the Psoriasis Area and Severity Index (PASI).4 Responses increased over time, and at 6 months, the proportions of patients achieving a 50% or 75% improvement in the PASI were 47% and 23%, respectively, in the ENBREL® 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 methotrexate therapy at baseline.
Radiographic Response
Radiographic changes were also assessed in the psoriatic arthritis study. Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24. A modified Total Sharp Score (TSS), which included distal interphalangeal joints (i.e., not identical to the modified TSS used for rheumatoid arthritis) was used by readers blinded to treatment group to assess the radiographs. Some radiographic features specific to psoriatic arthritis (e.g., pencil-and-cup deformity, joint space widening, gross osteolysis and ankylosis) were included in the scoring system, but others (e.g., phalangeal tuft resorption, juxta-articular and shaft periostitis) were not.
Most patients showed little or no change in the modified TSS during this 24-month study (median change of 0 in both patients who initially received ENBREL® or placebo). More placebo-treated patients experienced larger magnitudes of radiographic worsening (increased TSS) compared to ENBREL® 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 ENBREL®-treated patients had increases of 3 points or more in TSS. Inhibition of radiographic progression was maintained in patients who continued on ENBREL® during the second year. Of the patients with one-year and two-year x-rays, 3% (2 of 71) had increases of 3 points or more in TSS at one and two years.
Physical Function Response
In the psoriatic arthritis study, physical function and disability were assessed using the HAQ Disability Index (HAQ-DI)1 and the SF-362 Health Survey. Patients treated with 25 mg ENBREL® twice weekly showed greater improvement from baseline in the HAQ-DI score (mean decreases of 54% at both months 3 and 6) in comparison to placebo (mean decreases of 6% at both months 3 and 6) (p < 0.001). At months 3 and 6, patients treated with ENBREL® showed greater improvement from baseline in the SF-36 physical component summary score compared to patients treated with placebo, 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.
Ankylosing S |
