After Cladribine tablets had been rejected by regulators in 2010/11, Merck-Serono binned their respective development programme. This was in spite of excellent data on disease control and adverse events – if there hadn’t been those three cancers in the active arm of the CLARITY study (and none in the placebo arm). Although it subsequently turned out the malignancy risk with cladribine is no different than with other highly effective DMTs (in fact, more recent data suggest cladribine is at the lower end of the risk spectrum), the reputational damage was done, and the mud stuck firmly, indeed in some of my fellow neurologists’ minds it’s gotten stuck to the present day…
However, we looked at the data and saw huge opportunity, not primarily to help Merck recover from throwing the baby out with the bathwater, but to help people with MS in the UK and worldwide getting access to an effective drug that’s been sitting on the shelf for decades (licensed for hairy cell leukaemia), if only in a less convenient formulation than a tablet, namely as an injection.
Hence, from late 2014, we started using subcutaneously injected cladribine to treat pwMS who were either not eligible for NHS-funded DMTs or chose the compound over what was on offer at the time. Should you wish to revisit the early history of how this all came about, eventually leading to a collaboration with Merck that now (alongside the MS Society UK, National US MS Society, Barts Charity and – in particular – the NIHR) delivers #ChariotMS , click here and read MD’s White Knight Diaries.
Following peer review, our manuscript was accepted last Friday, the final day of #ECTRIMS2021. In it, we report our experience with subcutaneous cladribine in pwMS, an attempt at making a difference irrespective of NHS-DMT eligibility. The long list of authors illustrates broad support of this approach by colleagues with an interest in MS across the UK, and beyond.shorter-version
The abstract (full paper upload to follow) speaks for itself – subcutaneous cladribine is a promising option for pwMS across the disease spectrum who display disease activity based on either MRI and/or through elevated CSF neurofilament levels.
Among others, we hope this might help underpin the MS International Foundation’s (@MSIntFederation) drive towards improving access to effective immunotherapy in lower and middle income healthcare environments. The willingness of pwMS to undergo the treatment with BartsMS as well as our positive, albeit preliminary, outcomes were key factors in getting #ChariotMS underway. Thanks for all your courage and support !
CoI: I am the Chief investigator of ChariotMS, which is co-funded by Merck. I also serve on the steering committees of Merck’s MAGNIFY-MS trial, MS Masters Forum, MS Global Advisory network and ‘MS in the 21. century’. Lipomed supported an early ChariotMS investigator meeting in July 2017.