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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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Chest X-ray assessment using a detailed scoring method in a randomized trial of infliximab in subjects with chronic pulmonary sarcoidosis
From CHEST, 10/1/05 by M. Kavuru

PURPOSE: A radiographic scoring method (Muers et al Sarcoidosis Vasc Diffuse Lung Dis 1997;14:46) was devised to enable rigorous evaluation of chest radiographs (CXR) in subjects with pulmonary sarcoidosis. The purpose of this study was to evaluate the effect of infliximab on the radiographic appearance of pulmonary sarcoidosis using this scoring system.

METHODS: One hundred thirty-eight subjects were randomized to placebo, 3 or 5mg/kg infliximab at 34 centers. Subjects were infused at week 0, 2, 6, 12, 18, 24 and followed through week 52. Inclusion criteria included a diagnosis of sarcoidosis for [greater than or equal to] 1 year; a forced vital capacity (FVC) of [greater than or equal to] 50- [less than or equal to] 85% predicted and stage II or III on CXR. Two experienced radiologists, blinded to treatment and time of exam, scored the baseline, 6 and 24 week CXR for extent (0-4) and profusion (0-4) for each of four types of shadows: reticulonodular (R), mass (M), confluent (C), and fibrosis (F). Over 90% of CXR at each time point were available for review.

RESULTS: Scores in each domain were reasonably balanced at baseline. There were no significant differences in the M, C or F scores over time in any group. However, there were significant reductions in the R score at both time points in both treatment groups compared to baseline, with no change in the placebo group. Subgroup analyses showed that improvement in the primary endpoint (change in % predicted FVC at week 24) appeared to be restricted to subjects (n=78) with an R score >0 at baseline (5.2% improvement, p<0.001).

CONCLUSION: Infliximab appears to be effective in improving reticulonodular infiltrates on CXR without affecting the other type of shadows in subjects with chronic pulmonary sarcoidosis.

CLINICAL IMPLICATIONS: The treatment effect of infliximab in improving FVC appears restricted to patients with baseline CXR evidence of reticulonodular infiltrates.

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

M. Kavuru MD * R. M. duBois MD U. Costabel MD M. A. Judson MD M. Drent MD K. H. Lo PhD C. Andresen MD R. Schlenker-Herceg MD E. S. Barnathan MD R. P. Banghman MD R. T. Shipley MD Cleveland Clinic Foudation, Cleveland, OH

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