LYCOS RETRIEVER
Remicade: Ra
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Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in CD and RA, and may ... be important in a wide range of other immune-mediated inflammatory disorders.
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The approval of Remicade was based on results from the clinical trial ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), a double-blind, placebo-controlled, randomized clinical trial involving 428 patients at 34 clinical sites. At week 30 in the study, 50 percent of patients treated with Remicade and methotrexate, compared to 20 percent of patients receiving only methotrexate, exhibited reduced signs and symptoms of rheumatoid arthritis as measured by a standard assessment known as ACR20 (a 20 percent reduction in the number of tender, swollen joints as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation and pain).
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SPIRIT evaluated the efficacy of Remicade induction therapy in 249 patients who had previously received PUVA or systemic therapy for psoriasis. Patients were randomized to receive either placebo (n=51) or 3mg/kg (n=99) or 5 mg/kg (n=99) of Remicade monotherapy at weeks zero, two and six. At week 10, 88% and 72% of patients treated with 5 mg/kg and 3 mg/kg of Remicade, respectively, achieved PASI 75 versus only 6% of patients receiving placebo (P < 0.001 for both Remicade groups). Among those treated with 5 mg/kg of Remicade, nearly half achieved PASI 75 as early as week 4, and 58% experienced PASI 90, a 90% improvement from baseline, almost complete skin clearance, by week 10.
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