Tocilizumab

In Encyclopedia by Inès Levasseur Views: 6

The Tocilizumab is a humanized monoclonal antibody that blocks the action of interleukin receptor 6, it is used for its immunosuppressive action in rheumatoid arthritis.

The Tocilizumab is marketed in France by rock Chugai under the name of RoActemra, since December 2009.

Mechanism of action

Interleukin-6 plays a role in the onset of inflammation and is present at high levels in patients with rheumatoid arthritis. By preventing the Interleukin-6 on its receptors, the Tocilizumab reduces inflammation and other symptoms of rheumatoid arthritis.

Indication

The Tocilizumab is indicated for the treatment of active rheumatoid arthritis PR, moderate to severe adult patients: in combination with methotrexate in the case of: inadequate response or intolerance to at least a treatment of bottom (DMARDs) inadequate response or intolerance to a less an antagonist of tumor necrosis (anti-TNF) monotherapy an case of intolerance to methotrexate, or when the prosecution of methotrexate therapy is inappropriate in these patients.

Dosage

The usual dosage of RoActemra is 8 milligrams (mg) per kilogram (kg) of body weight. The physician may adjust this dose in some situations. RoActemra is administered once every 4 weeks, into a vein (intravenous infusion) for an hour.

Benefit of use of the Tocilizumab

The Tocilizumab has been the subject of five major studies involving total more than 4000 adults with moderate to severe rheumatoid arthritis. Four studies compared the Tocilizumab associated with methotrexate with placebo associated with methotrexate, and the fifth study compared the single administered Tocilizumab to methotrexate. In all of the five studies, the main assessment criteria of efficiency has been the number of patients who responded to treatment after six months. A response has been defined as a reduction in scores of symptoms of 20% or more, such as measured on a standard scale for rheumatoid arthritis (ACR20 response). Total 2439 patients included in these studies participated then in two studies on the effects in the long term of the Tocilizumab therapy.

The Tocilizumab has proven to be more effective than drugs for comparison with respect to the reduction of symptoms of rheumatoid arthritis. In three studies of patients who presented an inadequate response to methotrexate or other conventional treatment of rheumatoid arthritis, patients having added the Tocilizumab approved dose had a probability about four times higher to meet the treatment as those which added the placebo. 6 Months, one-third of the patients were in their disease remission (DAS28 < 2.6). In the fourth study including patients who had an inadequate response to TNF inhibitors, patients who received the Tocilizumab associated with methotrexate had a probability of response almost nine times higher than those who received placebo. As in patients with DMARDS fails, one-third of patients were in remission after 6 months (DAS28 < 2.6). The fifth study showed that patients who received the single Tocilizumab had a probability of response than patients treated with methotrexate alone. This shows the intrinsic activity of the molecule.

Long-term studies have shown that the response to the Tocilizumab is 33% at 6 months and 48% at 1 year, to 65% of remission (DAS28 < 2.6) 2 years.

Risk of use of the Tocilizumab

The most common side effects of the Tocilizumab are infections of the upper respiratory tract, including the usual symptoms are: cough, nasal obstruction, nasal discharge, angina and headaches.

Other side effects may appear: biological anomalies dose adjustments and potential treatments.

Infections that can result in:

• fever and chills,
• vesicles in the mouth or on the skin,
• pain in the stomach,
• persistent headaches.

The set of potential adverse effects is presented in the record of the Tocilizumab, in all cases, in the presence of effects referred to in the record or not, it is for the patient to inform your doctor or pharmacist.

In addition, the Tocilizumab is not to be used for people that may be hypersensitivity (allergy) to the Tocilizumab or any of the excipients. It should not be used in patients who have a severe infection or active. Special warnings and precautions: Infections. Tuberculosis. Complications of diverticulitis. Hypersensitivity reactions. Active liver disease and liver failure. Increases in liver transaminases. Hematological abnormalities. Lipid parameters. Neurological disorders. Malignancies. Vaccinations. Cardiovascular risk. Association with the anti-TNF. Sodium. INTERACTIONS WITH OTHER DRUGS AND OTHER FORMS OF INTERACTION. FERTILITY, pregnancy and lactation **: the women of childbearing age should use effective contraception during treatment (and up to 3 months after the judgment). RoActemra should not be used during pregnancy unless an absolute necessity. A decision on the continuation or interruption of breastfeeding or the continuation or discontinuation of treatment with RoActemra must be made taking into account the benefit of breastfeeding for the child and the interest of RoActemra for the mother. EFFECTS on ability to drive and use MACHINES: adverse: Infections and infestations, gastrointestinal disorders, skin and subcutaneous tissue, vascular disorders, haematological disorders and diseases of the lymphatic system, diseases of the nervous system, investigations, disorders of metabolism and nutrition, General disorders and administration site, eye abnormalities. Infections. Complications of diverticulitis. Infusion-related reactions. Immunogenicity. Hematological abnormalities. Increases in liver transaminases. Lipid parameters. Malignancies.

Physicians must carefully monitor for signs of infection during treatment and prescribe the Tocilizumab with caution to patients who have suffered from recurrent infections or long-term or diseases that can increase the risk of infections, such as diverticulitis or diabetes.

Live and attenuated vaccines are contraindicated in Tocilizumab.