Paediatric drugs
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Randomized Controlled Trial
Riluzole as an adjunctive therapy to risperidone for the treatment of irritability in children with autistic disorder: a double-blind, placebo-controlled, randomized trial.
A hyperglutamatergic state has been shown to play a possible role in the pathophysiology of autistic disorders. Riluzole is a glutamate-modulating agent with neuroprotective properties, which has been shown to have positive effects in many neuropsychiatric disorders. ⋯ Riluzole add-on therapy shows several therapeutic outcomes, particularly for improving irritability, in children with autism. However, its add-on to risperidone also results in significantly increased appetite and weight gain.
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Tocilizumab (RoActemra(®); Actemra(®)) is a recombinant humanized monoclonal antibody that acts as an interleukin-6 receptor antagonist. Both in the US and EU, tocilizumab has been approved for the treatment of two subtypes of juvenile idiopathic arthritis (JIA), namely systemic JIA (sJIA) and polyarticular JIA (pJIA), in patients aged ≥2 years. These approvals are based on favorable results from two randomized, double-blind, placebo-controlled, multinational, phase III trials in which patients aged 2-17 years with active sJIA (TENDER) or pJIA (CHERISH) received an intravenous dose of tocilizumab based on bodyweight every 2 or 4 weeks, respectively. ⋯ Infections (e.g. upper respiratory tract infection and pharyngitis or nasopharyngitis) accounted for just over one-third of all reported adverse events in this trial; tocilizumab-treated patients appeared to have an approximately 11 % risk of a serious infection per year of treatment. Clinical laboratory abnormalities included neutropenia and elevated aminotransferase levels. The tolerability profile of tocilizumab in CHERISH was generally consistent with that of the drug in TENDER.