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Dimethyl fumarate (DMF) is an oral therapy in development for multiple sclerosis (MS). Fumaric acids were first studied in MS in a Phase 1, open-label, baseline-controlled trial using the combination fumaric acid ester preparation Fumaderm. Based upon the encouraging Phase 1 results, Fumapharm partnered with Biogen Idec to conduct a Phase 2 trial of DMF in relapsing-remitting multiple sclerosis (RRMS). The use of DMF in autoimmune diseases arose from a personal view of the immune system, whereby autoimmunity is caused by disruption in the Krebs's cycle. The Phase 2 trial found that 720 mg/d of BG00012 reduced active inflammation. The Phase 3 trials provide pivotal and definitive evidence regarding the safety and efficacy of BG00012 in MS. Ongoing laboratory studies and advanced imaging studies in the Phase 3 trials are evaluating the neuroprotective effects of BG00012. Fumaric acids such as BG00012 are an exciting new class of potential MS treatment.
In the first of two studies reported by Rose and coworkers, patients with relapsing-remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) were initiated on daclizumab with the same dose. A positive effect on relapses was observed. Safety data coming from daclizumab's regulatory-approved indication in renal transplantation suggest that the drug is overall safe and well tolerated. However, safety data from other of-label indications, such as uveitis, seem to confirm safety concerns regarding a mild increase in infection rate as well as skin reactions. Daclizumab is a novel and promising therapy for MS patients now being tested as monotherapy in a large Phase 3 trial using an active comparator arm. Daclizumab's mechanism of action is not fully understood, but an increase in regulatory immune cells has been related to clinical response and is now thought to play a more important role than direct anti-inflammatory effects derived from IL-2 blockade.
Although multiple sclerosis and other disorders of myelin formation and repair are most commonly associated with adults, they can also occur in infants, children and adolescents. Up to 5 percent of those with MS experience symptoms before the age of 18, and the number of cases diagnosed is rising. There is a lack of awareness about these diseases in childhood, however, even amongst pediatric neurologists and MS specialists. Demyelinating Disorders of the Central Nervous System in Childhood provides comprehensive coverage of these diseases, highlighting throughout the differences between management in childhood and in adults. With sections dedicated to the diagnosis, course, treatment and biology of pediatric MS, detailed chapters on other childhood demyelinating diseases, including acute disseminated encephomyelitis, optic neuritis, acute complete transverse myelitis and neuromyelitis optica, are also provided. Essential reading for pediatric neurologists and MS specialists, this book will also be valuable reading for adult neurologists and pediatricians.