Biodrugs
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Alemtuzumab is a humanized anti-CD52 monoclonal antibody. Treatment in humans results in a rapid, profound, and prolonged B- and T-cell lymphopenia. Subsequently, lymphocyte reconstitution by homeostatic mechanisms alters the composition, phenotype, and function of T-cell subsets, thus allowing the immune system to be 'reset'. ⋯ The latter is observed in a third of treated patients, commonly thyroid disease but other target cells have been described including cytopenias. Marketing authorization applications have been submitted for the use of alemtuzumab in multiple sclerosis to the Food and Drug Administration and the European Medicines Agency, with licensing expected in 2013. Here, we discuss the outlook for alemtuzumab in multiple sclerosis in light of the currently available therapies, outcomes of and lessons learnt from clinical trials, and the overall position of monoclonal antibodies in modern treatment strategies.
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Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero(®)) is a unique vaccine containing four main immunogenic components: three recombinant proteins combined with outer membrane vesicles derived from meningococcal NZ98/254 strain. After three doses of 4CMenB (administered at 2, 3, and 4 months or 2, 4, and 6 months of age) in vaccine-naive infants, the majority of infants had seroprotective human complement serum bactericidal assay (hSBA) antibody titers against the meningococcal serogroup B test strains selected to be specific for the vaccine antigens in randomized, open-label or observer-blind, multicenter, phase IIb or III trials. In extensions to the phase III trial, two doses of 4CMenB administered between 12 and 15 months of age in vaccine-naive infants, and a single booster dose of 4CMenB administered at 12 months of age in vaccine-experienced infants, also elicited robust immunogenic responses. ⋯ The reactogenicity of 4CMenB was generally acceptable in clinical trials. However, the vaccine was associated with more solicited systemic adverse events (particularly fever) in infants when coadministered with routine infant vaccines than when these vaccines were administered alone. In conclusion, 4CMenB effectively elicited immune responses against meningococcal serogroup B test strains selected to be specific for the vaccine antigens in infants, adolescents, and adults.