November 7, 2011 (Amsterdam, the Netherlands) — A new study suggests that natalizumab (Tysabri, Biogen Idec/Elan) may be an effective option for the treatment of active pediatric multiple sclerosis (MS).
The study, a cohort study of 35 pediatric patients treated out to 23 months with natalizumab, showed that the drug was safe and well-tolerated and was effective in suppressing disease activity in almost all patients.
“I think the message is that the pediatric patient is no different in their response,” to natalizumab than adult patients, senior author Giancarlo Comi, MD, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy, told Medscape Medical News. “So there is absolutely no reason not to treat pediatric patients.”
Neurologists have not been used to treating patients with pediatric MS aggressively because there has not been a lot of experience in this population, Dr. Comi added. However, pediatric MS tends to have a more active presentation, “so it’s better to have exactly the same attitude.”
The results were presented by first author Angelo Ghezzi, MD, from Centro Studi Sclerosi Multipla dell’Ospedale di Gallarate in Lombardy, Italy, on behalf of the Italian Society of Neurology’s MS Study Group here at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).
Nonresponders
About 30% of children with pediatric MS have an inadequate response to first-line medications such as interferon beta-1a or glatiramer acetate, Dr. Ghezzi noted in his presentation. Natalizumab, which in phase 3 and phase 4 studies has shown strong suppression of clinical and magnetic resonance imaging (MRI) activity in adult patients with relapsing-remitting MS, has been shown in previous case reports and observational studies to be a “promising therapeutic option” for pediatric patients as well as adults, the authors say.
In this non–industry-sponsored observational study, 15 Italian centers enrolled pediatric patients (younger than 18 years) with definite MS to look at the long-term safety and effect on clinical evolution of the disease of natalizumab therapy. Natalizumab has been authorized in Italy for pediatric patients with MS who have a severe or aggressive evolution of disease and no other therapeutic option, the authors note.
Patients were treated with natalizumab if they had had at least 2 relapses in the previous 2 years and/or incomplete recovery despite treatment with interferon or glatiramer acetate; or had experienced a recent severe relapse with incomplete recovery.
The study included 35 patients (21 girls), 25 of whom had previously been treated with at least 1 disease-modifying agent, and 13 of whom had previously been treated with more than 1 agent. Patients received a standard dose of 300 mg natalizumab every 28 days.
Patients underwent clinical and laboratory evaluation on treatment days and had an MRI every 6 months. Follow-up was 23.8 months (standard deviation, 9.8 months), covering 24.7 infusions, and was more than a year in all cases.
The mean age at the start of natalizumab treatment was 15 years, and the mean disease duration pretreatment was 28 months (±20 months). The mean number of attacks for these patients was 4.6, and the mean number of attacks in the year previous to natalizumab treatment was 2.6. Patients had a mean of 5.8 gadolinium-enhancing lesions at baseline.
“We observed an impressive reduction of disease activity,” the researchers note, with reductions seen in relapse rate, Extended Disability Status Scale scores, and active gadolinium-enhancing lesions on MRI compared with baseline.
Read More from Medscape
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