123 Twenty years of clinical studies on anti-Pseudomonas IgY to cystic fibrosis patients

Abstract

Objectives Clinical studies with CF-patients on Anti-psIgY (Anti-Pseudomonas IgY) to prevent infections with PA (Pseudomonas aeruginosa) in order to find out efficacy and adverse events have been running in Sweden for 20 years. Anti-psIgY has got Orphan drug designation 2008. They are background for Phase III study started in 2011. Methods Two studies for efficiency and advert events. Phase II 1995–2002: Two groups with intermittently PA-infected patients – one treated with Anti-psIgY, the other without IgY. Prolonged study 2002–now: Followed as first study but without controls. Two CF women (one pregnant twice) continued with Anti-psIgY during pregnancy. One boy transplanted 12 years ago after infections with PA and atyp. mycobact. Results Group with Anti-psIgY: 2.35 pos PA cultures/100 months; Untreated group: 7 pos PA/100 months. Duration from first to second colonization was significantly prolonged for treated/control group (Kaplan–Meier p = 0.015). The time from first to chronic infection was prolonged in IgY group. Few infections minimized antibiotics. Lung function and BMI well preserved. Prolonged group: similar effects. Totally 33 patients included. Together they gargled >100,000 doses. No adverse events reported. All pregnancies went well and three healthy babies. Transplanted pat has not had any pseudomonas or atyp. mycobact. Discussion Anti-PsIgY has good results in efficiency and absence of advert events. It reduces antibiotics and risk of resistance. Gargling is convenient. Treatment is cost effective. The cost for IgY less than for antibiotics. Costs for hospitalization is lower. Anti-psIgY might be registered, if phase III gives similar result.