lower schreef op 21 augustus 2018 15:52:
[...]
[Modbreak IEX]: Aangepast, gelieve elkaar niet persoonlijk aan te vallen.]
An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension
www.ncbi.nlm.nih.gov/pmc/articles/PMC...Lanadelumab (DX-2930) is a fully human monoclonal antibody inhibitor of plasma kallikrein. Inhibition of plasma kallikrein is an attractive and rational therapeutic strategy for HAE as it prevents the production of bradykinin. Lanadelumab is a highly potent (Ki = 125 pM), specific, and rapid inhibitor of plasma kallikrein that was discovered by phage display technology and is produced in Chinese Hamster Ovary cells using standard methods
Anti-drug antibodies
Positive results in 3/92 (3.3%) post-dose samples from 2/23 patients (8.7%)
None were neutralizing
Patients must have a historical baseline attack rate of at least one attack per 12 weeks.
==================
The safety and side effects of
monoclonal antibodies
theory.bio.uu.nl/immbio/pdf/Therapeut...Immune reactionsImmune reactionsmAbs are generally well tolerated in humans, despite containing elements that may be recognized by the recipient as foreign and can therefore cause activation of immune and innate reactions28. Acute reactions follow-ing infusion of mAbs can be caused by various mecha-nisms, including acute anaphylactic (IgE-mediated) and anaphylactoid reactions against the mAb, serum sickness, tumour lysis syndrome (TlS) and cytokine release syndrome (CRS). The clinical manifestation can range from local skin reactions at the injection site, pyrexia and an influenza-like syndrome, to acute anaphylaxis and systemic inflammatory response syndrome, which could befatal.
InfectionsInfectious diseases are a well-described side effect of certain mAbs, and they are a reflection of an acquired immunodeficiency, generally due to removal of the target ligand for that mAb. Indeed, particular types of infections illustrate the protective function of the tar-get ligand in the normal immune system, and provide insights into the function of this molecule to combat particular pathogens.
=======
Shire krijgt Lanadelumab er vast wel door heen. Deze mab zal veel mensen helpen en op termijn ga je zien aan welke risico's men is bloodgesteld.
Zo startte men ook met plasmaproducten. "Het helpt en later de risico's"
mab
en.wikipedia.org/wiki/Monoclonal_anti...