In September 2006, the US FDA approved the use of infliximab in adults with chronic, severe plaque psoriasis (FDA 2006). There have been numerous case reports of the efficacy of infliximab in various inflammatory skin conditions diseases; the FDA approved infliximab for chronic severe plaque psoriasis in adults in September 2006. Psoriasis is a common; typically chronic papulosquamous skin disease that may be associated with a seronegative spondyloarthropathy. Etanercept is FDA approved for RA, PsA, ankylosing spondylitis, and chronic to severe plaque psoriasis in adults. For the treatment of severe plaque psoriasis and PsA (with or without MTX), infliximab is delivered by an intravenous infusion over a 2-hour period at weeks 0, 2, and 6 followed by maintenance infusions every 8 weeks.
Treatment of adult patients with fistulizing Crohn’s disease for the reduction in the number of draining enterocutaneous and rectovaginal fistula(s) and to maintain fistula closing. Gottlieb and colleagues reported on a larger trial of 249 patients with severe plaque psoriasis who were randomized to receive an infusion of 1 of 2 different doses of infliximab or placebo at 0, 2, and 6 weeks (Gottlieb, 2004). In September 2005, the FDA approved REMICADE as the first and only biologic for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in adults with moderately to severely active UC who have had an inadequate response to conventional therapy. REMICADE is also approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or PUVA (psoralen plus ultraviolet A light). At the time of this analysis, April 2005, the registry included 6,290 adult CD patients who were divided into two groups according to treatment. In September 2006, FDA approved REMICADE for the treatment of chronic severe plaque psoriasis.
In September 2006, the US FDA approved the use of infliximab in adults with chronic, severe plaque psoriasis (FDA 2006). Infliximab was FDA approved in 2006 for the treatment of Crohn’s disease in children aged 6 years and older. In adult psoriasis patients, infliximab is reported to carry an increased risk of tuberculosis reactivation and congestive heart failure. Chronic plaque psoriasis is a lifelong disease with a substantial impact on the physical well-being and quality of a patient s life. However, long-term treatment in patients with moderate to severe psoriasis is limited by the potential for toxic effects on organs, such as renal, hepatic or bone marrow, in addition to teratogenicity and malignancies that are associated with the traditional systemic therapies. It received FDA approval for the treatment of rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriatic arthritis. Br J Dermatol, 155 (2006), pp.
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The U.S. Food and Drug Administration (FDA) has approved the following TNF antagonists for use in specific indications:. In September 2015, the American College of Rheumatology (ACR), in conjunction with the Spondylitis Association of America and the Spondyloarthritis Research and Treatment Network (Ward, 2015), released recommendations for both pharmacologic and non-pharmacologic treatment of AS and non-radiographic axial spondyloarthritis (SpA). Infliximab and golimumab are approved by the FDA for adult RA, and only when given in combination with methotrexate. 2006), chronic moderate to severe plaque psoriasis (Leonardi, 2003), active AS (van der Heijde, 2006a), and children 2 years of age or older with moderately to severely active PJIA (Lovell, 2000). REMICADE received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with moderately to severely active UC in September 2005 and in October 2006, REMICADE received FDA approval for maintaining clinical remission and mucosal healing indications in adults living with UC. Treatment of adult patients with chronic severe plaque PsO who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. HORSHAM, Pa., Sept. 27, 2006 /PRNewswire/ — Centocor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE(R) (infliximab) for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The currently available biological therapies for psoriasis are etanercept, infliximab, adalimumab, and ustekinumab; each of these therapies displays differential properties based on their unique mechanisms of action, which target either tumor necrosis factor or interleukin (IL)-12/23 cytokines, and each biologic has accumulated significant controlled clinical trial and long-term use data to support a positive benefit/risk profile in psoriasis. C Adults with chronic, severe (ie, extensive and/or disabling) plaque psoriasis.