Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.
Summary of "Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study."
In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated.
To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe plaque psoriasis.
A total of 912 patients received 50 mg subcutaneous etanercept once weekly (OW) for the first 12 weeks of this extension study. Thereafter, eligible patients could maintain the 50 mg QW dose (n = 321) or escalate to 50 mg twice weekly (BIW; n = 591) anytime thereafter based on one of three predetermined criteria.
Etanercept was well tolerated during 1056 patient-years of exposure; no difference was observed between the 50 mg QW and 50 mg BIW dosages in rates of adverse events and infections. Improvement in skin disease was maintained throughout the study. Patients who stopped and then restarted etanercept also showed improvement in psoriasis.
Psoriatic patients continued to benefit from open-label etanercept treatment, both continuous and interrupted therapy, which was generally well tolerated after a combined 2.5 years of experience.
St. Louis University, St. Louis, MO 63117, USA. firstname.lastname@example.org
This article was published in the following journal.
Name: Journal of drugs in dermatology : JDD
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Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and...
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psorias...
The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoria...
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric subjects with moderate to severe psoriasis.
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Medical and Biotech [MESH] Definitions
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.
A persistent increase in synaptic efficacy, usually induced by appropriate activation of the same synapses. The phenomenological properties of long-term potentiation suggest that it may be a cellular mechanism of learning and memory.
A persistent activity-dependent decrease in synaptic efficacy between NEURONS. It typically occurs following repeated low-frequency afferent stimulation, but it can be induced by other methods. Long-term depression appears to play a role in MEMORY.
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the United States or a foreign country.
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