Minimal change disease and focal segmental glomerulosclerosis in adults: rituximab

How well does rituximab work?

It is difficult to say how well rituximab works for treating minimal change disease and focal segmental glomerulosclerosis in adults because the studies were small and did not have good comparison groups. Also, the amount of rituximab given was different and some people were also taking other medicines such as steroids.

Some studies showed that rituximab helped to reduce the number of times the condition flared up within a year and the amount of protein leaking into the urine. Some people were able to reduce or stop other medicines such as steroids and those that suppress the immune system when rituximab was given. These studies did not compare rituximab with other treatments for minimal change disease or focal segmental glomerulosclerosis, so it is hard to say how well rituximab worked compared with other treatments. One small study in adults whose condition had come back after a kidney transplant compared people taking rituximab with people taking other treatments. Rituximab was no better than other treatments at improving minimal change disease or focal segmental glomerulosclerosis.

What are the possible harms or side effects?

Rituximab has been used for a number of years and in a lot of people for other conditions so the side effects are well known. In the studies that looked at how well rituximab worked for treating minimal change disease and focal segmental glomerulosclerosis in adults, the most common side effects were related to the infusion of rituximab. Side effects included unexpected low blood pressure that lasted for a short time, itchy red eyes, cough, hiccup and a skin rash. One person had inflammation in the lungs (bronchopneumonia) 2 months after treatment with rituximab. One study reported a long-term complication of slightly reduced white cells (also called mild leukopenia).

Side effects that have occurred in people taking rituximab for the conditions for which it is licensed are discussed below.

For every 10 people who are given rituximab through a drip, more than 1 can have a reaction, usually within the first 2 hours. This might include fever, chills and shivering. Less often, people have pain where the drip is put in, blisters, itching, sickness, tiredness, headache, breathing difficulties, swelling in the tongue or throat, an itchy or runny nose, sickness, flushing or palpitations, a heart attack, or a low number of platelets (blood cells that help the blood to clot). If people have any of these symptoms, the drip might need to be slowed down or stopped. Paracetamol and an antihistamine are given before each dose of rituximab to manage some of these symptoms. These reactions are more likely the first time rituximab is given but the person and their doctor may decide to stop treatment if the reactions are serious.

People who are given rituximab can get infections more easily during or after treatment. These are often minor (for example, a viral infection such as a cold) but there have been cases of more severe infections such as pneumonia and urinary infections. Rituximab shouldn't be given to people who already have a severe infection, or to people with hepatitis B. People will be checked for this before they are prescribed rituximab.

Rituximab can cause a serious infection of the brain (called progressive multifocal leukoencephalopathy or PML) which can be fatal. This type of infection is very rare. If a person on rituximab has memory loss, becomes confused, has difficulty walking or sight loss, they should tell their doctor immediately. Rituximab can also very rarely cause severe blistering skin that can be life threatening. Redness (often with blisters) may appear on the skin or inside the mouth, the genital areas or the eyelids. Sometimes people get a fever. People should talk to their doctor immediately if they have any of these symptoms.