Disease modifying drug therapy Other drugs used in MS
The currently licensed disease modifying drugs are the most widely used drugs in the treatment of MS. In the majority of cases one of these licensed drugs will best meet the needs of the person with MS. However, there are certain, rather more exceptional contexts, within which drugs that are not licensed for MS may be given to people with MS.
Unlike the disease modifying drugs licensed for MS, unlicensed drugs do not have recommendations dictating how they should be used. There is a significant difference between these drugs and the currently licensed drugs in terms of the safety and efficacy data that is available for their use in MS. Any recommendations that are made with regards to unlicensed drugs are made on an individual patient basis at the discretion of the prescribing physician.
Unlicensed drugs that are used in MS can be divided into two main groups: drugs that are licensed for use in conditions other than MS; and drugs which are still in development and are therefore not licensed for any condition.
Off-label prescribing
When drugs that are not specifically licensed for MS are prescribed to people with MS, they are used 'off-label'. This means that the medicines regulatory authority has not recommended the use of the drug in MS and there is limited safety or efficacy data relating to its use in the condition. In such cases, the prescribing physician takes full responsibility for the patient's progress on the drug. The prescribing physician will therefore be driving the decision to start treatment and making recommendations regarding the individual's suitability for treatment with the drug.
Because MS is considered to be an autoimmune disease, drugs which are licensed for the treatment of other autoimmune diseases such as rheumatoid arthritis and psoriasis are occasionally prescribed off-label to people with MS.
A drug that is commonly used in this way in some of the larger neurology centres in the UK is mitoxantrone, a chemotherapy drug.
Clinical trials of unlicensed drugs
Where a drug does not have a licence for use in any condition it is usually because it is still being tested. Every new drug has to go through rigorous testing of its effectiveness and safety through a series of clinical trials usually over a number of years. People who are given these drugs can only receive them by taking part in a clinical trial. If you are considering taking part in a clinical trial it is important to consider the implications and risks associated with taking a drug that is experimental.
In order to be eligible to participate in a clinical trial you must meet the eligibility criteria defined by the trial investigators and a referral from either your neurologist or MS nurse will be required. Your neurologist or MS nurse will base their clinical advice or recommendation on a number of factors including the unique clinical and radiological characteristics of your MS.
| Name of drug | How it is given in MS | Licensed for a different condition |
|
|---|---|---|---|
| Alemtuzumab (Campath) | Intravenous infusion | yes | |
| BG-12 | Orally | yes | |
| Cladribine (Leustat) | Orally | yes | |
| Daclizumab (Zenapax) | Subcutaneous injection | yes | |
| Fingolimod | Orally | no | |
| Laquinimod | Orally | no | |
| MBP8298 | Intravenous infusion | no | |
| Rituximab (Rituxan) | Intravenous infusion | yes | |
| Teriflunomide | Orally | no | |
| Tovaxin | Subcutaneous injection | no |
The table includes some of the more notable drugs being studied for their safety and effectiveness in MS. Drug development is fast moving and fast changing and it is likely that information in this table will change.
- To keep abreast of the latest drug developments in MS, visit the research pages of the MS Trust website
If you are interested in finding out about clinical trials currently recruiting people with MS you can search the Clinical Trials registry online. The website is by no means a complete registry of clinical trials in MS and the information provided there should be used only to supplement the advice and information provided by your consultant and MS nurse.
Compassionate use
Compassionate use describes the process through which people with debilitating conditions and no satisfactory treatment alternatives, gain access to drugs outside the context of a clinical trial. Only in rare and exceptional circumstances therefore, is this often controversial practice considered for people with MS.
As with off-label prescribing, physicians prescribing drugs on the grounds of compassionate use, take full responsibility for the patient's progress on the drug. In order for a physician to prescribe the drug, it must be in clinical research, preliminary data must exist to indicate that it is likely to be effective and relatively safe, and the drug manufacturer must be actively seeking marketing approval.
A physician will not consider compassionate use of a drug unless you have run out of reasonable treatment options, either with licensed or off-label drugs.