Cladribine CIS study

"I was asked last night what was the highlight of the AAN 2013. Without a doubt the Cladribine CIS, or ORACLE, study. As you can see from the following graph cladribine treatment reduces the chances of a second attack, or developing clinically definite MS, by 67%; these are the best CIS results to date."

"What is also very impressive is that after 1 year the cladribine treated subjects flat-line, i.e. very few people have a second attack in year 2. This may mean that cladribine takes time to have its maximum effect. I wonder what will happen if these cohort of study subjects were followed long term? May be those who haven't developed MS by year 1 will never develop MS."

"Could cladribine prevent the development of MS?"

"What is also clear is that there is no cancer signal in this study. I wonder what would happen if this data set was resubmitted to the European Medicines Agency? Would they still take a negative view?"

"Cladribine is not only an effective therapy, it is also a convenient therapy being given as tablets (10 days per year), it is well tolerated and has a good short to intermediate term safety profile. Cladribine is also rapidly cleared from the body so it is an ideal tablet for young woman wanting to get on top of their MS and start a family. Finally, it is an induction therapy and may not have to be given beyond year 2."

"The ORACLE study is not only my AAN highlight, but also my low-light;  how could we let this drug die? Surely, MSers & CISers need to have the option of choosing cladribine for their MS?"


"The following is the full poster that was presented at the AAN. Professor Leist has given me permission to make it available via the blog."



"It is interesting that an ORACLE is a person considered to be a source of wise counsel or prophetic opinions, or an authoritative or wise statement or prediction. Is the ORACLE study saying that we may be able to cure MS in a subgroup of MSers with induction therapy? Similar, to Alemtuzumab, we would need to wait 15 to 20 years to get an answer. Wouldn't it be a tragedy if we ignored the ORACLE?"

CoI: multiple

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