Infliximab

November 1, 2006

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Remicade

InfliximabCentocorMonoclonal antibody approved for the treatment of chronic plaque psoriasis

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Safety. Patients treated with infliximab are at increased risk for infections, including tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections. Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test, and treatment of latent tuberculosis should be initiated prior to therapy with infliximab. Physicians should monitor patients receiving infliximab therapy for signs and symptoms of active tuberculosis, including those patients who are tuberculin skin test-negative. Serious infections have been observed in clinical studies with concurrent use of anakinra and another TNF-alpha inhibitor, etanercept, with no added clinical benefit compared with etanercept alone.Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in rare cases with infliximab therapy. Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving infliximab. Hypersensitivity reactions, varying in time of onset, have been associated with infliximab. Most of these reactions, which include urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hours of infliximab infusion. The most common adverse events reported in association with infliximab therapy include abdominal pain, coughing, sinusitis, pharyngitis, rhinitis, rash, pruritus, fever, headache, and back pain.

Dosing. The recommended dose of infliximab for the treatment of chronic plaque psoriasis is 5 mg/kg administered as an IV infusion, followed by additional similar doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.