Main indications in lupus

Rituximab does not have a Market authorisation for lupus, but experts recognize potential effectiveness in severe lupus, especially in cases of severe haematological, renal or visceral involvement.

Why did your doctor offer you Rituximab ?

Your doctor has offered this treatment because the data published to-date suggest that Rituximab may be an effective treatment for lupus that does not respond well to a combination of corticosteroid therapy and at least one immunity-modifying drug such as cyclophosphamide, azathioprine, mycophenolate mofetil, or methotrexate.

How does Rituximab work?

Rituximab is one of the drugs called "biotherapies" or "biologics." This means that it will act very precisely on a biological element that is a cell (white blood cell or leukocyte) of your immune system. These cells specifically targeted by Rituximab are B lymphocytes.

This treatment is an antibody quite comparable to the antibodies you naturally have in your body, but able to attach to the B lymphocytes that are partly responsible for your disease to eliminate them.

Dosage

1 g on Day 1 and Day 14 or 375 mg/m² on Day 1, Day 7, Day 14 and Day 21 intravenously only, combined with a prior injection of corticosteroids (Methylprednisolone 100 mg)

How is Rituximab used?

This drug is only given in the hospital. This is why your doctor will refer you to a department that is familiar with and authorized to use this treatment. You should be given this medication intravenously either as 2 infusions given 2 weeks apart or as 4 infusions given 1 week apart.

You will also continue other treatments for your autoimmune disease.

Do not change your treatment without talking with your doctor.

What will you do before the 1^st infusion of Rituximab ?

- You must know your medical history well and in particular:

- If you have had infections

- If you have had viral hepatitis (B or C)

- If you have had allergies to medications or food

- Make sure that you are well vaccinated against tetanus, poliomyelitis, Covid-19, and depending on the advice of your doctor, against influenza and pneumococcus. Otherwise, you will have to revaccinate at least 3 to 4 weeks before the 1^st infusion of Rituximab.

- If you are a woman, you must be sure that you are not pregnant within 6 months of Rituximab and you should not breastfeed your baby because the effects of Rituximab during pregnancy and lactation are not known.

During the infusion of Rituximab

The effects you may feel during the infusion are: difficulty breathing; swelling of the tongue and lips; headaches; an appearance of heat and/or chills; redness or the feeling of scratchy skin (pruritus); nausea and/or vomiting; tingling of the nose and/or sneezing; tingling in the throat; pain and/or abnormally rapid heartbeats.

A severe reaction to the product, which requires permanently stopping the infusion, is rare: it occurs in less than 2 out of 100 patients.

Main side effects

- A reaction to the product that occurs especially after the 1^st infusion is possible.

Most often, it is not an "allergy". When they occur, these reactions (headache, redness, fever, low blood pressure) are very rarely serious, most often disappear with the slowing down of the infusion and does not force one to stop the drug permanently.

- Infection may occur with Rituximab as this drug reduces immunity related to B lymphocytes. These are most often infections of the lungs, bronchi or urinary tract related to bacteria. These are usually minor infections that can be easily treated.

Exceptionally, infections of the central nervous system linked to a virus (JC virus) can occur, triggering an often irreversible leukoencephalopathy.

- Neutropenia is possible and usually appears late.

Contraindications

- Hypersensitivity to the product

- Progressive cardiovascular disease (in particular, angina pectoris)

- Pregnancy and lactation

Precautions for use

- In case of a decrease in immunoglobulins (hypogammaglobulinemia), the use of Rituximab should be discussed to avoid aggravating this biological abnormality.

- No dose adjustment in case of renal or hepatic failure

- Viral hepatitis B or C warrants monitoring of virological status

Monitoring

- Blood count 1/month, then every 3 months

- Control of immunoglobulin levels and circulating B lymphocyte levels in case of reprocessing by Rituximab

- Clinical monitoring