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A reduction of at least 70% in the mean number of active T1 gadolinium-enhancing lesions per subject per scan, the mean number of active T2 lesions per subject per scan, and the mean number of combined unique lesions per subject per scan was also observed with cladribine (reductions ranging from 73% to 88%, depending on magnetic resonance imaging [MRI] measure and dose group; P < 0.001 for all measures).
Overall, adverse-event rates were comparable between treatment groups, with the exception of lymphopenia, which occurred more frequently with cladribine, 26.7% with both treatment groups combined vs 1.8% with placebo. Other adverse events with cladribine included leukopenia (7.1%), decreased lymphocyte count (4.4%), and vertigo (4.2%).
"Our findings suggest that annual short-course treatment with cladribine tablets, given 8 to 20 days during the year, depending on the dosing regimen, was significantly effective across multiple important clinical and MRI efficacy measures," Bruno Musch, MD, head of global clinical development for neurology at EMD Serono, told Medscape Neurology.
Cladribine may be taken at short intermittent courses, and this will "hopefully address the unmet need for an oral therapy in MS to improve compliance, adherence, and convenience," he said. EMD Serono expects to file an indication for cladribine in relapsing-remitting MS with the Food and Drug Administration in mid-2009, he added.
Intermittent Therapy a "Plus"
"An oral therapy is certainly an advance, and 1 taken so few times a year is an added plus," said Dr. Mark S. Freedman, professor of neurology at the University of Ottawa, in Ontario, and director of the multiple sclerosis research clinic at Ottawa Hospital.
"There are always safety concerns when one considers a possibly longer-term treatment," he told Medscape Neurology, "but the study doesn't really indicate any major problems. It is unlikely that the few cancerous conditions that were noted are any more frequent than would be expected for an age-matched population.
"It is imperative that physicians carefully consider all the options for a patient," he said. "Ongoing studies with cladribine will help us to know if treatment beyond 2 years is necessary. Until such time, cladribine will probably find itself readily replacing natalizumab in the treatment algorithm for drug escalation in patients breaking through first-line therapies."
Overall, adverse-event rates were comparable between treatment groups, with the exception of lymphopenia, which occurred more frequently with cladribine, 26.7% with both treatment groups combined vs 1.8% with placebo. Other adverse events with cladribine included leukopenia (7.1%), decreased lymphocyte count (4.4%), and vertigo (4.2%).
"Our findings suggest that annual short-course treatment with cladribine tablets, given 8 to 20 days during the year, depending on the dosing regimen, was significantly effective across multiple important clinical and MRI efficacy measures," Bruno Musch, MD, head of global clinical development for neurology at EMD Serono, told Medscape Neurology.
Cladribine may be taken at short intermittent courses, and this will "hopefully address the unmet need for an oral therapy in MS to improve compliance, adherence, and convenience," he said. EMD Serono expects to file an indication for cladribine in relapsing-remitting MS with the Food and Drug Administration in mid-2009, he added.
Intermittent Therapy a "Plus"
"An oral therapy is certainly an advance, and 1 taken so few times a year is an added plus," said Dr. Mark S. Freedman, professor of neurology at the University of Ottawa, in Ontario, and director of the multiple sclerosis research clinic at Ottawa Hospital.
"There are always safety concerns when one considers a possibly longer-term treatment," he told Medscape Neurology, "but the study doesn't really indicate any major problems. It is unlikely that the few cancerous conditions that were noted are any more frequent than would be expected for an age-matched population.
"It is imperative that physicians carefully consider all the options for a patient," he said. "Ongoing studies with cladribine will help us to know if treatment beyond 2 years is necessary. Until such time, cladribine will probably find itself readily replacing natalizumab in the treatment algorithm for drug escalation in patients breaking through first-line therapies."
Cladribine continued