Side Effects of Zinbryta, an FDA-approved MS Drug, Need to Be Considered Too
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Would you agree to be treated with an MS disease-modifying therapy that has been developed to help you but has side effects that could, maybe only rarely but still could, lead to serious illness or even death?
It’s just like the vaccination of young children. There, the debate about whether to vaccinate or not in is an easy decision for health authorities and the vast majority of healthcare professionals. But there is a significant minority of concerned parents and some professionals who are not convinced. Well, that’s something of an understatement — they are opposed to forced vaccinations. They want to be able to choose.
In our case, we MS patients do have the right to choose and that decision is a personal one.
I was diagnosed with MS in 2002 but have never been prescribed any medicines, and so have never faced that decision. The decision is whether or not to take them and put the possible side effects out of my head, or instead decline the drugs because of what might just happen.
Now, another new drug has been approved by the U.S. Food and Drug Administration (FDA) for use as a disease-modifying therapy for adults with relapsing-remitting MS. Approval for use in other countries will depend on their individual practices and procedures.
The new drug is called Zinbryta (daclizumab, Biogen and AbbVie). It is taken by subcutaneous, or under-the-skin, injection every four weeks.
In a Phase 3 trial, Zinbryta was shown, after nearly three years, to reduce annual relapse rates by 45% and to significantly reduce disease activity observed on MRI scans.
Because of its safety profile, the prescribing information indicates that the use of Zinbryta should generally be reserved for people who have had an inadequate response to two or more MS therapies.
Whoa, hold on just a minute. Its safety profile? Just what are they trying not to say here? With that thought in my mind, I decided to look at the side effects.
The prescribing information includes a boxed warning about the potential for severe liver injury, including life-threatening and fatal events. For “fatal events,” read “death.”
It also highlights other important risks of Zinbryta treatment, including inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy). Additional warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal thoughts. As if people with MS are not depressed already!
Zinbryta will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program. This is to ensure that ongoing periodic monitoring will be maintained to detect potential problems. The most common side effects were skin rash and elevated liver enzymes. Serious infections also occurred. In people treated with Zinbryta compared to Avonex, there was an increased incidence of serious infections (4% versus 2%), serious skin reactions, elevated liver enzymes and liver injury, gastrointestinal disorders, and depression.
Having considered all this, and given Zinbryta its approval, the FDA recommends that healthcare professionals perform blood tests to monitor an individual’s liver function prior to starting Zinbryta, as well as monthly before each dose, and for up to six months after the last dose.
So, now you know. If you have relapsing-remitting MS, Zinbryta might well be the very best treatment for you. But you need to know the downsides, too — the worst of which is death. Well, I suppose that’s one cure for multiple sclerosis.
Zinbryta is a trademark of Biogen and AbbVie. Avonex is a registered trademark of Biogen.
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