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woensdag 26 juli 2017

The Lancet: [Articles] Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-rando...

[Articles] Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial
This first-ever demonstration in human beings shows that a prophylactic mRNA-based candidate vaccine can induce boostable functional antibodies against a viral antigen when administered with a needle-free device, although not when injected by a needle-syringe. The vaccine was generally safe with a reasonable tolerability profile.
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[Articles] Recombinant human C1 esterase inhibitor for prophylaxis of hereditary angio-oedema: a phase 2, multicentre, randomised, double-blind, placebo-controlled crossover trial
Prophylaxis with recombinant human C1 esterase inhibitor provided clinically relevant reductions in frequency of hereditary angio-oedema attacks and was well tolerated. In view of the pharmacokinetic profile of recombinant human C1 esterase inhibitor, our results suggest that efficacy of C1-inhibitor replacement therapy might not be a direct function of plasma trough concentrations of C1 inhibitor.
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[Comment] Recombinant human C1 esterase inhibitor for hereditary angio-oedema
Patients with the autosomal inheritable disease hereditary angio-oedema have recurrent swelling of subcutaneous and cutaneous tissues. The frequency of attacks varies enormously between individuals and can range from a few swellings per year to multiple attacks per week. In most cases, acute treatment is sufficient, but prophylactic treatment can reduce the burden of illness for severely impaired patients.1 Available treatments for hereditary angio-oedema prophylaxis comprise either plasma-derived C1 esterase inhibitor concentrates or attenuated androgens, such as danazol.
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[Articles] Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial
Transition to a bone-forming agent is common practice in patients treated with bisphosphonates, such as those who fracture while on therapy. In such patients, romosozumab led to gains in hip BMD that were not observed with teriparatide. These data could inform clinical decisions for patients at high risk of fracture.
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[Comment] Bone-forming agents in non-responders to bisphosphonates
Osteoporosis is a chronic disease requiring long-term treatment. Oral bisphosphonates, which act by inhibiting bone resorption, are most commonly prescribed but inadequate response, development of intolerance, or fear of long-term side-effects sometimes necessitate change to an alternative therapy.1 One option is to switch to teriparatide, a bone-forming agent, but enthusiasm for this strategy is tempered by the blunting of the bone mineral density (BMD) response to teriparatide seen in patients previously treated with antiresorptives.
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