The safety of alefacept using a reduced schedule for monitoring T cells (original) (raw)

2004, Journal of the American Academy of Dermatology

Psoriasis is a chronic, relapsing skin disease that often requires multiple courses of treatment. Alefacept improves psoriasis by selectively targeting the T cells involved in psoriasis pathogenesis. It has been shown to have an encouraging efficacy and safety profile in multiple randomized, placebo-controlled studies and retreatment trials. To understand the best way to manage existing therapies during a course of alefacept, an international study is being conducted under conditions reflective of the clinical practice setting (ie, combining alefacept with other agents). Patients are eligible for enrollment provided they have chronic plaque psoriasis requiring systemic therapy, are at least 16 years of age, have CD4ϩ T-cell counts at or above the lower limit of normal (at least 300 cells/mm3 if on a stable dose of prednisone), and are naïve to alefacept therapy. Patients may receive up to 3 treatment courses of intramuscular alefacept 15 mg. Each course consists of 12 weekly injections followed by 12 weeks of observation. Retreatment courses of alefacept are provided for patients whose disease has progressed to require systemic therapy and whose CD4ϩ T-cell counts meet the above criteria. In each course, patients are allowed to receive 1 concomitant psoriasis therapy in addition to alefacept. To date, enrolled patients are receiving alefacept in addition to low-potency topicals (31%), high-potency topicals (29%), methotrexate (15%), cyclosporine (12%), ultraviolet B light (6%), systemic retinoids (6%), and prednisone (1%). Methotrexate is being tapered over the first 4 weeks of alefacept therapy. To avoid flares, patients receiving cyclosporine must continue such treatment through week 11 of the alefacept dosing period followed by gradual tapering over the following 6 weeks. An objective of this study is to determine the efficacy of initial and repeat courses of alefacept and the duration of response after the first 2 courses in combination regimens. Physician Global Assessment is being used to evaluate efficacy. Circulating total, CD4ϩ, and CD8ϩ lymphocyte counts are being measured at various time points throughout the study. All patients who have completed 12 weeks of treatment will be included in the efficacy analysis. Efficacy results will be presented, which should provide valuable insight into the management of other psoriasis therapies when used concurrently with alefacept.