Tocilizumab: What is it?
Tocilizumab is an immunosuppressive drug, i.e. a drug that is used to reduce the body’s immune response. This drug belongs to the pharmacological class of monoclonal antibodies. It was developed by the pharmaceutical company La Roche.
How does it work?
Tocilizumab is a biologic drug that works against the interleukin-6 receptor (IL-6), a cytokine which plays an important role in the body’s immune response, and is involved in the pathogenesis of various diseases, for example, autoimmune diseases.
The drug has been studied and used with good effect mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of rheumatoid arthritis in children.It has recently been suggested for the treatment of severe pneumonia caused by the coronavirus.
Treating pneumonia caused by the coronavirus: A rational approach
The gravity of pneumonia caused by the coronavirus appears to be characterized by the body’s excess immune response to the virus, rather than the damage to the lung cells. As a consequence, anti-inflammatory drugs have been tested in the treatment of COVID-19, with moderate success. This response led to the use of the immunosuppressive drug Tocilizumab, which had sporadically been used in lung problems related to autoimmune diseases, specifically rheumatoid arthritis (1) and Sjogren’s syndrome (2). Trials are still underway to test its effectiveness.
How is it administered?
The drug is administered in a single intravenous infusion.
Up to now, there are no official scientific studies or publications about the use of Tocilizumab in treating COVID-19, mainly because there hasn’t been any time to carry out such research. Therefore, the data that we are providing is an EXPERIMENTAL ATTEMPT in a serious clinical context, which justifies the absence of an official scientific method normally used in clinical trials.
So far, Tocilizumab has been used to treat 21 patients in China which have shown improvement in the first 24-48 hours after administering the drug.
In Italy, it has been used to treat 2 patients who have shown encouraging progress. In light of these results, a large-scale trial will be carried out in some Italian hospitals (Sacco in Milan, Spallanzani in Rome, and Policlinico in Padua). Currently, the drug has been distributed in the various hospitals’ satellite intensive care units.
It has recently been announced that La Roche, the pharmaceutical company that manufactures Tocilizumab, has offered to supply the drug free of charge for the current trial (8).
On March 17, 2020, it was announced that a randomized trial will start on 330 patients starting March 19, 2020. We are looking forward to developments in terms of the effectiveness of the drug.
Why only 330 patients?
There are only 330 patients taking part in the trial because this number of patients (the sample) is sufficient to verify the effectiveness of the drug, technically known as the “statistical reliability“. If the drug works on this sample, there is a very high probability that it will work on all patients. If it does not work, then it is unlikely that the drug will have any positive effect on a larger number of patients.
Marco De Nardin, M.D., Anesthesiologist, and Critical Care Doctor
(4) Roy Fleischmann et al., LITHE: Tocilizumab Inhibits Radiographic Progression and Improves Physical Function in Rheumatoid Arthritis (RA) Patients (Pts) at 2 Yrs with Increasing Clinical Efficacy Over Time, ACR, 2009
(6) S. Yokota, T. Tanaka; T. Kishimoto, Efficacy, safety and tolerability of tocilizumab in patients with systemic juvenile idiopathic arthritis., in Ther Adv Musculoskelet Dis, vol. 4, nº 6, dicembre 2012, pp. 387-97, DOI:10.1177/1759720X12455960
(7) Cotugno:esiti incoraggianti da una terapia sperimentale contro il Covid-19, su napolitoday.it, 8 marzo 2020