What is Mavenclad used for in MS?
Mavenclad is a more effective (category 1.2) DMD; in clinical trials, people taking Mavenclad had about 50% fewer relapses than people taking placebo. In clinical trials, MRI scans showed that people taking Mavenclad had fewer, smaller or no new areas of active MS (lesions). Mavenclad may also slow down the build-up of disability due to MS.
Who can take Mavenclad?
In England, Wales and Northern Ireland, Mavenclad can be prescribed if your MS remains active while taking any one of the DMDs or if you have very active MS (two or more disabling relapses in one year and MRI evidence of new areas of MS activity).
In Scotland, the Scottish Medicines Consortium (SMC) has recommended that Mavenclad can be prescribed if you have rapidly evolving severe relapsing remitting MS (at least two relapses in the previous year and MRI evidence of MS activity); or you have relapsing remitting MS that has responded inadequately to treatment with another disease modifying drug (at least one relapse in the previous year and MRI evidence of MS activity).
Mavenclad can only be prescribed by a neurologist.
It's important that you tell your MS team if you have any health problems or are taking other medicines. Mavenclad may not be appropriate if you have existing medical conditions including liver or kidney problems, active cancer, serious infections such as HIV, hepatitis or tuberculosis or are taking other medicines which suppress the immune system (including methotrexate, ciclosporin, cyclophosphamide and azathioprine).
Conception and pregnancy
Mavenclad should not be used by men or women while they are trying for a family, or in pregnant women. In men it could affect the development and quality of your sperm for up to six months after treatment, and in women it could seriously harm your developing baby.
Both men and women should use effective contraception for six months after taking Mavenclad to prevent pregnancy. If you or your partner become pregnant within six months of your taking Mavenclad contact your neurologist or MS nurse as soon as possible.
If you become pregnant after six months of your first course of Mavenclad but before your second course of Mavenclad you will need to discuss delaying your second treatment course.
How do I take Mavenclad?
You take Mavenclad as a pill in two treatment courses, twelve months apart:
- in the first course you take Mavenclad pills for up to five consecutive days in the first month and for up to five consecutive days in the second month
- the second course is taken 12 months later; again you take Mavenclad pills for up to five consecutive days in the first month and for up to five consecutive days in the second month.
The actual number of tablets you have to take will depend on your weight.
People who took part in the clinical trials did not need further treatment with Mavenclad in years three and four. Ongoing studies are monitoring whether there is a need for further treatment in later years.
What side effects could I get with Mavenclad?
Common side effects include a reduced white blood cell count (lymphopenia) and herpes (oral herpes and shingles).
Common side effects (affecting more than 1 person in 100):
- decrease in white blood cells (lymphopenia)
- herpes virus infection (shingles or cold sores)
- hair loss
A full list of side effects is included in the manufacturer's Patient Information Leaflet.
Assessment before treatment
Before starting a Mavenclad treatment course you will have tests to check for tuberculosis, HIV and hepatitis. Your white blood cell levels will also be checked.
Assessment during treatment
Once you've started treatment you'll have tests to monitor white blood cell levels at three and seven months in year one, before you start treatment in year two and again at three and seven months in year two. No additional monitoring is required in year three and four.
If you have previously had cancer talk to your doctor before starting treatment with Mavenclad. This is because single events of cancer have been seen in those taking Mavenclad. Initial research showed more cases of cancer in those taking Mavenclad compared to those taking placebo. However, further analysis of the data and comparison with data from clinical trials of other disease modifying drugs found no evidence of an increased risk of cancer from taking Mavenclad.
For more information see the manufacturer's Patient Information Leaflet.
How does Mavenclad work?
Mavenclad works by gradually reducing the numbers of certain types of white blood cell (T and B lymphocytes). These are thought to be involved in the abnormal immune response which attacks the myelin coating of nerve cells that causes the damage associated with MS. The components of the immune system involved with fighting infections are largely spared, reducing the risk of infections after treatment compared to some other DMDs.
What are the results so far?
Evidence for the effectiveness of Mavenclad has come from one large study.
- CLARITY - Mavenclad compared to placebo
CLARITY was a two year, phase III study in more than 1,300 people comparing two doses of Mavenclad against placebo. Compared to placebo, there was a reduction in the relapse rate of 58%. Later analyses of the study results also found that brain volume loss was reduced and numbers of participants with no evidence of disease progression (NEDA) were increased in those taking Mavenclad.
- New England Journal of Medicine 2010;362(5):416-426. Summary A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.
- Neurology Neuroimmunology and Neuroinflammation 2015;2:e158. Full article No evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine.
- NICE Technology Appraisal Guidance 493 Full guideline Cladribine tablets for treating relapsing – remitting multiple sclerosis [TA493]