R treatment of acute HAE episodes in the randomized, double-blind FASTR treatment of acute HAE

R treatment of acute HAE episodes in the randomized, double-blind FAST
R treatment of acute HAE episodes in the randomized, double-blind FAST 1 and FAST 2 studies. Source: European Medicines Agency (http://www.ema.europa.eu/ humandocs/PDFs/EPAR/firazyr/H-899-en6.pdf).approved for the treatment of acute HAE by the European Medicines Agency in July 2008 and is currently prescribed in several European countries and Brazil. An additional Phase III study of icatibant for acute treatment of HAE was initiated in 2009 with the goal of obtaining sufficient data to obtain FDA approval.OPTIMIZING HEREDITARY ANGIOEDEMA TREATMENTThe recent development of multiple therapies for the treatment of HAE has increased the availability of effective medications. In some instances, individuals with HAE have unprecedented therapeutic options. These advances provide opportunities to optimize the medical care and quality of life for HAE patients, but are accompanied by both practical and societal challenges. Providers treating HAE will need to consider a number of important factors when consulting with and managing the treatment of individual patients. Because of the wide variability in symptoms for individual HAE patients, treatment strategies will ideally take into account a number of patient-specific factors.19 Clearly, these include the frequency and severity of angioedema symptoms, which may principally PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28607003 determine whether regular prophylactic therapy or intermittent on-demand acute therapy is most beneficial. Rapidity of attack progression and access to acute medical care may also play a role when considering long-term prophylactic versus as-needed therapy. The frequency of variability in the therapeutic response to new agents and their adverse effects have not yet been fully?2010 World Allergy Organizationdetermined. Variability is evident in individual responses to prophylactic C1INH therapy,20 and adverse effects are well demonstrated by the rare hypersensitivity reactions to ecallantide.21 Research efforts to better define or predict this variability will improve the tailoring of therapy to individual patients. Drug-specific features will also be important in therapeutic decision-making. Though study protocol differences make direct comparisons of data difficult, the C1INH products, ecallantide and icatibant seem to have comparable treatment effects,15,18,22,23 so that clinical efficacy does not seem to be a strong factor for distinguishing among them. With regard to safety, plasma C1INH products have a long and extensive history of safe use despite a theoretical risk of transmission of infectious agents. Some concern exists for allergic reactions to recombinant C1INH and ecallantide, but recent study data PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/28827318 demonstrate this to be a greater concern for ecallantide, with its small but real risk of hypersensitivity reactions.15,24 Icatibant appears to have an excellent safety profile to date, although clinical experience is LY2510924 cost somewhat limited. Route of drug administration is currently a distinguishing feature. C1INH products are presently approved only for intravenous use, which may present logistical challenges in some situations. There is considerable interest in the use of C1INH products subcutaneously; however, at present this remains in clinical development. Consequently, because of the unpredictability of HAE attacks, patients may face challenges in rapidly accessing IV products through clinics or emergency departments. Self-infusion programs and infra-SRiedlWAO Journal ?September 2010, Supplementstructure are likely to imp.