The European Medicines Agency (EMA) has started a review of alemtuzumab following recet reoports of sde effects affecting the heart, blood vessels, liver and immune system. These side effects are rare but potentially serious.
As a temporary measure while the review is being carried out, the EMA has advised that alemtuzumab should only be started in people with relapsing remitting MS that continues to be very active despite taking at least two disease modifing drugs or where other DMDs cannot be taken. So it moves from first line to third line. Those in the US will be saying I told you so as it was placed as a third line drug.
If you have already started Lemtrada and are due to receive further infusions, you should continue with treatment. Anyone who has been treated with alemtuzumab should continue to have monthly blood and urine tests for four years after the last treatment course
- immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body);
- problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
- severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
So Mr Angry will be on my case for being the bearer of this bad news and for contributing to the change in the label (Neutrophils and the anti-drug response). However, this is one reason why you have a Phase IV period where you collect data on the rare side effcts. This has been a story that has just kept giving of recent time as more and more unusual autoimmunities have appeared as case reports. Whilst the thyroid problems were dismissed as treatable others have been significantly more serious.
- New cases of side effects have been reported with alemtuzumab, including some affecting the heart, blood vessels, lungs and liver.
- You should get medical help immediately if you experience symptoms of:
- acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
- bleeding in lungs: such as trouble breathing and coughing up blood
- stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain (Really? you have a stroke and you are not going to seek medical help?)
- liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
- an inflammatory condition known as haemophagocytic lymphohistiocytosis: such as fever, swollen glands, bruising and skin rash.
It is perhaps such a shame that we (ProfG & I) were dismissed over five or six years ago when we when to Boston with a proposal to try and attack the autoimmune problem. There was no enough interest at the time (maybe our ideas were considered to be rubbish) and my ideas of the autoimmunity were Pooh Poohed. The problem now, is that there are alternatives and it will be difficult to recruit…so a window of opportunity was missed. This is rater ironic as it was suggested there was a window of oppertunity to use the drug to work in early relapsing verses progressive MS. Had this been ignored and the right trial-design being used alemtuzumab or more likely the “son of alemtuzumab” would probably have been availablle for progressive MS years before ocelizumab got there..
Now is an oppertunity to work out why alemtuzumab works so well but causes all the problems it does.
So I say thanks very much for the rebuttals, it brought out the ferret (teeth lock when they bite and so don’t let go) in me and the brought out “Le penseur”and has been the giver for a few papers and a lot of student projects, with more to come:-).
So who will be on the PRAC? What will they be looking at?, with Brexit on the cards, Is that a reason I’ve been ignored :-(. I know some questions, I would be asking.
Maybe ProfG (or an alter ego) will come out to give a neuros take on the issue.. as he will have more inside knwledge