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Infliximab

Infliximab (Remicade®) is a powerful drug used to treat auto-immune disorders like Crohn's disease and rheumatoid arthritis. Infliximab is known as a "chimeric monoclonal antibody" (the term "chimeric" refers to the use of both mouse and human components of the drug i.e. mouse binding VK and VH domains and human constant Fc domains). The drug reduces the amount of active TNF-α (tumour necrosis factor alpha) in the body by binding to it and preventing it from signaling the receptors for TNF-α on the surface of cells. more...

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TNF-α is one of the key cytokines that triggers and sustains the inflammation response. Remicade was invented at New York University School of Medicine and developed by Centocor, a pharmaceutical company owned by Johnson & Johnson.

Pharmacology

It is made up of part-human part mouse protein, and is administered by intravenous infusion (usually on an outpatient basis). Before infliximab is administered a test for tuberculosis must be performed, as infliximab has been shown to increase the risk of reactivation of latent tuberculosis. Other potential side effects include skin rash, fever, tiredness and difficulty breathing.

Safety

Since the drug's approval and wide-spread use, significant concerns about the safety of infliximab have been raised. After a number of studies and reports of significant adverse reactions in patients receiving infliximab therapy (including serious and sometimes fatal blood disorders, infections, lymphoma and other cancers, serious liver injury, and central nervous system disorders), the U.S. Food and Drug Administration issued a warning to doctors instructing them to screen and monitor potential patients more carefully.

Other uses

Case studies have been done into other uses of infliximab, such as to treat skin diseases. Remicade (infliximab) has been approved for treating ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis (EU), rheumatoid arthritis, and ulcerative colitis.

There have been numerous case reports of the efficacy of infliximab in various inflammatory skin conditions diseases; psoriasis, in which increased TNFα has been demonstrated, is the most promising indication (Gupta and Skinner, 2004).

Read more at Wikipedia.org

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Randomized, double-blind, placebo-controlled trial of infliximab in patients with chronic pulmonary sarcoidosis
From CHEST, 10/1/05 by R.P. Baughman

PURPOSE: To evaluate the safety and efficacy of infliximab, a TNF[alpha] inhibitor, in improving lung function, symptoms, and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite treatment.

METHODS: Patients (n=138) were randomized (1:1:1) to infliximab [3 or 5mg/kg] or placebo at 34 centers in US and EU. Patients were infused at week 0, 2, 6, 12, 18, 24 and followed through week 52. Eligibility criteria included a diagnosis of sarcoidosis for [greater than or equal to] 1 year, an American Thoracic Society dyspnea score of [greater than or equal to] 1 despite treatment with [greater than or equal to] 3 months of prednisone ([greater than or equal to] 10mg) or immunomodulator therapy or both, evidence of parenchymal disease (Stage II or III) on chest radiograph and a forced vital capacity (FVC) of [greater than or equal to] 50- [less than or equal to] 85% predicted. The 1[degrees] endpoint was defined as the change from baseline in the % of predicted FVC at week 24. Major secondary endpoints included the St. George's Respiratory Questionnaire, 6-minute walk distance, and Borg's CR10 dyspnea Score.

RESULTS: Baseline characteristics were well balanced, with 42% of patients receiving immunomodulators and corticosteroids. There was a significant improvement in the 1[degrees] endpoint in the combined infliximab group (delta 2.5%, p = 0.038). Results did not differ substantially between the infliximab doses. Subgroup analysis demonstrated greater benefit in patients with more extensive sarcoidosis disease burden, duration, activity or severity. There were no significant differences in major secondary endpoints. Ten percent of patients had infusion reactions and ~5% discontinued treatment due to adverse events (no difference between placebo and infliximab). There were no instances of delayed hypersensitivity reactions or anaphylaxis. One patient (receiving placebo) died of respiratory failure due to pulmonary hypertension secondary to sarcoidosis.

CONCLUSION: Infliximab appears to be effective in improving pulmonary function in symptomatic patients with chronic pulmonary sarcoidosis with a reasonable safety profile.

CLINICAL IMPLICATIONS: Addition of infliximab to corticosteroid therapy with or without immunomodulators is a promising new treatment strategy. These results should be confirmed in a larger, more severely affected chronic pulmonary sarcoidosis population.

DISCLOSURE: R Baughman, Grant monies (from industry related sources) Research grants; Consultant fee, speaker bureau, advisory committee, etc.; Employee.

R. P. Baughman MD * M. A. Judson MD U. Costabel MD R. M. duBois MD M. Drent MD M. Kavuru MD K. H. Lo PhD C. Andresen MD R. Schlenker-Herceg MD E. S. Barnathan MD University of Cincinnati Medical Center, Cincinnati, OH

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