Patients with active psoriatic arthritis who received Amevive (alefacept) achieved significant improvement in disease. Patients treated with Amevive also experienced less progression of disease, as measured by radiographic assessment, than placebo-treated patients after 24 weeks, according to the findings from a recently completed Phase II study, presented at the annual meeting of the American College of Rheumatology (ACR).
Philip Mease, lead study investigator of Swedish Medical Centre and University of Washington School of Medicine in Seattle said, "These data for ACR score of disease activity demonstrate that a single course of Amevive, in combination with methotrexate, produces a statistically significant impact on disease compared with methotrexate alone, and that response continued after a second 12-week course of treatment."
New findings presented show that the progression of joint damage, evaluated after 24 weeks, was delayed in subjects receiving Amevive and methotrexate in the placebo-controlled portion of the study (first course) compared with placebo and methotrexate. As measured radiographically with X-rays of hands and feet by the modified Sharp score, the mean change from baseline at six months was 0.3 in the treatment arm versus 1.3 in the placebo arm. At week 48 (open-label second course), results were inconclusive.
Response measured after an open-label second course of treatment suggested that the impact on disease may be continued for almost one year (48 weeks). "These initial results, if confirmed, suggest that Amevive may offer relief to patients with both psoriasis and psoriatic arthritis," said Mark Lebwohl, professor and chairman of the department of dermatology at The Mount Sinai School of Medicine in New York.
It is estimated that psoriatic arthritis afflicts up to 30 per cent of people with psoriasis, causing stiffness, pain, swelling and reduced range of motion in the joints. An immune system disease, psoriatic arthritis can be as severe for some patients as rheumatoid arthritis. In some cases, it leads to joint destruction that is irreversible.
Amevive is the only approved biologic for psoriasis that is eligible for Medicare Part B coverage and has a J code (J0215), which helps accelerate the Medicare reimbursement process.