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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).

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Assessment of infliximab efficacy in extrapulmonary sarcoidosis using a novel assessment tool: results from a randomized trial
From CHEST, 10/1/05 by M.A. Judson

PURPOSE: Anecdotal evidence has suggested improvement in extrapulmonary sarcoidosis with infliximab therapy, but this has not been prospectively studied. The purpose of this study was to evaluate the efficacy of infliximab on extrapulmonary sarcoidosis in patients with chronic pulmonary sarcoidosis who are symptomatic despite treatment.

METHODS: One hundred thirty-eight patients were randomized (1:1:1) to placebo, 3 or 5mg/kg infliximab at 34 centers. Patients were infused at week 0, 2, 6, 12, 18, 24 and then followed through week 52. Patients were included with a diagnosis of sarcoidosis for [greater than or equal to] 1 year and therapy for [greater than or equal to] 3 months with prednisone ([greater than or equal to] 10 mg/day) and/or immunomodulators. Physicians assessed each of 17 extrapulmonary organs and the lungs for involvement at each visit on a 0-6 scale (0=not affected; 6=very severe). The total of extrapulmonary scores were compared across the groups. Serum angiotensin converting enzyme (ACE) levels were measured as an indication of total granuloma burden.

RESULTS: The mean ([+ or -] SD) extrapulmonary total scores and ACE levels were similar at baseline across the groups. Mean scores fell steadily throughout the 24 week period in both treated groups. At week 24, there was a significant reduction in combined infliximab group (p=0.002). Mean ACE levels rose in the placebo group at 12 and 24 weeks whereas they fell significantly in both treatment groups at both times.

CONCLUSION: Infliximab appears to be effective in reducing extrapulmonary sarcoidosis involvement as assessed by physicians using a novel 7 point assessment tool. ACE levels are also reduced by infliximab, prior to the detection of any clinical improvement in the extrapulmonary total score.

CLINICAL IMPLICATIONS: Addition of infliximab to corticosteroid therapy with or without immunomodulators is a promising new treatment strategy for patients with extrapulmonary involvement. Further validation of the clinical meaningfulness of changes in the total score needs to occur. Additional follow up off treatment will be important to assess the duration of the improvements noted.

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

M. A. Judson MD * U. Costabel MD M. Drent MD M. Kavuru MD R. M. duBois MD K. H. Lo PhD R. Schlenker-Herceg MD E. S. Barnathan MD R. P. Baughman MD Medical University of South Carolina, Charleston, SC

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