Cladribin – a new option for relapsing MS

On August 25, 2017, the European Medicines Commission EMA approved the active ingredient Cladribin under the trade name MAVENCLAD® for the treatment of relapsing multiple sclerosis (MS) in patients with high disease activity. Some of you may remember. In 2011 – at that time there were no effective oral MS drugs – two preparations were on the verge of approval: Fingolimod, which was approved in 2011 under the trade name Gilenya, and the substance Cladribin, which, despite good efficacy data, did not receive approval from the European Medicines Agency (EMA) at that time. The reason for this was safety concerns – the EMA was skeptical after more tumors had occurred in the treatment group than in the placebo group – this phenomenon should be further investigated.

Therefore, Cladribin has been further tested in various study programs for efficacy and safety in recent years. It has now been found that the frequency of tumors under Cladribin does not differ from that of other MS drugs. There have also been few side effects during the now more than eight-year observation of the substance, so that, against the background of a quite convincing effect in the placebo-controlled approval study (significant reduction in relapse rate, disability progression and MRI activity), approval has now been granted.

Given its mechanism of action, Cladribin is an interesting drug. It is almost “identical” to deoxyadenosine, which is needed for the energy metabolism of cells, but also for the synthesis of nucleic acids RNA and DNA. Due to its biochemical modification, unlike dexoxyadenosine, Cladribin cannot be broken down by cells. Once smuggled into the cell and activated via certain enzymes, it long-lastingly reduces especially the proliferation of T and B cells, which are responsible for the autoimmune inflammation in MS.

The intake of Cladribin is relatively “convenient”: Two oral cycles (1 – 2 tablets over 4 – 5 days depending on individual body weight) are given in the first and second year of therapy, i.e., the drug achieves its effect on a maximum of 20 days within a treatment period of two years, which has lasted up to 4 years in the study situation – in fact without further refreshment of the medication in a part of the patients. This is quite an exciting result. With this mode of action, Cladribin has similarities to the antibody Alemtuzumab, but with the advantage of oral administration and easier logistical administration. Cladribin is also interesting because it is a small molecule and, unlike a monoclonal antibody, is able to enter the central nervous system, i.e., the site of action in MS.

Cladribin therefore has some potential to change the therapy of relapsing MS. However, we will certainly have to wait for experiences in reality before we can give a final evaluation regarding effectiveness and side effects. The interesting questions will be where this preparation fits in in view of the already available options. After approval for patients with high disease activity, the drug is currently competing with substances such as Fingolimod, Natalizumab and ultimately Alemtuzumab. The easy intake is certainly a great advantage, the mechanism of action of the substance, which ultimately requires strict contraception in men and women within the first 6 months after intake, could be seen as a major disadvantage for the substance.

I consider Cladribin to be another interesting enrichment of the therapy of relapsing MS, but I am somewhat curious to see how this new “old” substance will be accepted by patients and neurologists.

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