Wednesday, 21 October 2009

Novel disease modifying therapies: data presented at ECTRIMS 2009

The 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Dusseldorf in September 2009 brought together leading international experts in MS to share and discuss recent advances in MS research. We were presented very promising new treatments evaluated in phase II and III trials.
Oral therapies have reached an advanced phase of development, with some of the molecules having completed phase III trials. Data from the cladribine and fingolimod phase III trials were presented at the congress, as well as the phase II trial with teriflunomide and new data illustrating the mechanism of action of laquinimod. Prof. Giovannoni (London, UK) presented the findings of CLARITY, the phase III trial comparing two doses of cladribine and placebo in relapsing remitting MS patients. The study showed that a short course of cladribine tablets significantly increased the proportion of patients without disease activity after two years. Prof. Barkhof (Amsterdam, The Netherlands) presented TRANSFORMS, the phase III trial of oral fingolimod compared with intramuscular interferon beta-1a in relapsing-remitting multiple sclerosis. Twelve months of fingolimod therapy significantly reduced MRI inflammatory activity and cerebral volume reduction. The results of the phase II trial with two different doses of oral teriflunomide or placebo added to interferon beta for 6 months in patients with relapsing remitting multiple sclerosis were presented by Prof. Freedman (Ottawa, Canada). Both doses of teriflunomide were shown to decrease the inflammatory activity seen in MRI. Prof. Brück (Gottingen, Germany ) and Comi (Milano, Italy) summarized the studies evaluating laquinimod’s mechanism of action and the current data of efficacy and safety of laquinimod. They suggested dual neuroprotective and immunomodulatory properties, and promising efficacy data.
Alemtuzumab is a monoclonal antibody to CD52, a surface receptor of lymphocytes. We already know that alemtuzumab is superior over subcutaneous interferon beta 1-a (Rebif-44) in reducing relapse rate and accumulation of disability in treatment-naive relapsing-remitting MS patients for three years. In this Congress, Dr. Coles (Cambridge, UK) presented the primary efficacy outcomes of CAMMS223 at 4 years, which showed that alemtuzumab maintains its superiority to SC IFNB-1a.
Two trials with secondary-progressive MS patients were presented. Unfortunately, intravenous dirucotide failed to delay disease progression compared to placebo in a phase III study with 612 patients, as shown by Prof. Freedman.  Likewise, lamotrigine did not show any benefit in decreasing rate of cerebral atrophy and slowing disease progression in a placebo-controlled phase II trial in 120 people with secondary progressive MS, as was shown by Dr. Kapoor (London, UK).
Finally, Prof. Freedman disclosed the consensus of the mesenchymal stem cell transplantation (MSCT) experts held in Paris earlier this year. MSCT might be an important and exciting new modality for the treatment of MS. The formation of the International MSCT Study Group and the conception of a common protocol to be used worldwide will help advance this promising therapeutic line.
Overall, some new therapies seem to be clinically beneficial for MS patients. However, ongoing trials are underway to evaluate clinical benefit and safety data before these new drugs may be widely administered.

Dr Isabel Bosca, Visiting Neurologist Barts and The London

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