How do the new oral treatments fit into our therapeutic armamentarium?
Disclosure: Personal compensation received for participating on advisory boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees, from: Bayer-Schering Healthcare, Biogen-Idec, Merck-Serono, Novartis, Teva-Aventis, Elan, GSK, and Genmab
Research support received from: Bayer-Schering Healthcare, Biogen-Idec, Merck Serono, Novartis, Genmab and TEVA-Aventis
Member of Steering Group of the CLARITY study
24 slide(s) – 00:24:29– English –2010-09-28
The currently approved first-line therapies, IFN-beta and glatiramer acetate, are only partially effective, but have an excellent safety profile.The second-line therapies natalizumab andmitoxantrone are more effective but have potentiallymore serious side effects. Natalizumab carries a risk of progressive multiple leucoencephalopathy (PML) estimated to 1 in 1.000 treated patients, and mitoxantrone may induce acute myeloid leukaemia in 1 out of 150 treated patients. Five oral therapies have completed, or are close to completion of pivotal phase III trials and are expected to be availablewithin the next 1-3 years. The new oral treatments fall into 2 groups:
1) Cladribine and fingolimod that probably will be the first 2 treatments to be launched have an efficacy resembling that of the current second-line therapies natalizumab and mitoxantrone. Both drugs seem relatively safe in a 2-year perspective but serious adverse effects have been reportedwith both drugs.These drugswill become competitors to the current second-line therapies, but might also be used as first-line therapies in patients with high disease activity.
2) Laquinimod, teriflunomide and BG12 aremore comparable to the current first-line therapies as to efficacy and safety. If phase III trials confirm the results of the reported phase II trials, these therapies will probably replace the current injectable first-line therapies.Until the results of phase III trials are available it is not possible tomake any comparison between these 3 oral therapies.The balance between efficacy, safety and convenience will be decisive for the choice of drug.