Autoimmune haemolytic anaemia: rituximab

How well does rituximab work?

One high quality study looked at how well rituximab worked for treating warm type autoimmune haemolytic anaemia in adults who hadn't received any past treatment for the condition. The study found that 12 months' treatment with prednisolone (a steroid) and rituximab was better at increasing a person's haemoglobin to a normal level than prednisolone alone.

Other studies in children, young people and adults with warm type autoimmune haemolytic anaemia, and in adults with cold type autoimmune haemolytic anaemia, showed that rituximab increased a person's haemoglobin level. However, the studies were not well designed and they didn't compare rituximab with other treatments, making it difficult to be very sure how well rituximab will work for someone with autoimmune haemolytic anaemia.

What are the possible harms or side effects?

In the high quality study that looked at how well rituximab and a steroid worked for treating warm type autoimmune haemolytic anaemia in adults with no past treatment for the condition, the most common side effects were breathlessness, tiredness, headache, indigestion and difficulty sleeping (several of which were probably related to the steroid).

Side effects that have occurred in people who take 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 to it; this usually happens during or within the first 2 hours of treatment. The reaction might include fever, chills and shivering. Less often, some people might get reactions including 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, vomiting, flushing or palpitations, a heart attack, or a low number of platelets (cells in the blood that help the blood to clot). If people do get any of these symptoms during the treatment, the drip might need to be slowed down or stopped or they might need to take an antihistamine or paracetamol. These reactions are more likely to happen the first time a person is given rituximab and are less likely to happen after further treatments. However, 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 infections will often be minor (for example, a person may get a viral infection such as a cold after a treatment) but there have been cases of more severe infections such as pneumonia or urinary infections. Rituximab shouldn't be given to people who already have a severe infection, or to people with hepatitis B.

Rituximab can cause a serious infection of the brain (called progressive multifocal leukoencephalopathy or PML) which can be fatal, but 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 conditions 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.

Everyone who is being treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given a 'patient alert card' each time they are given rituximab. The alert card contains important safety information.