EPS03.3 Longer term tolerance and likely adherence to TOBI Podhaler in CF adults

Abstract

Background In a 6-month clinical trial, TOBI Podhaler (TIP) has been shown to be safe and generally well tolerated compared to nebulised Tobramycin Inhalation Solution (TIS) in CF subjects [1]. However, there is little ‘real world' evidence for longer-term tolerance or likely adherence to TIP. Objectives To assess the longer term tolerance and likely adherence to TIP at our large regional UK adult CF centre. Methods We conducted a retrospective observational study of CF adults who completed a test dose of TIP in our centre between 1/1/12 and 1/1/13. Patient reported tolerance was documented and likely adherence was calculated by pharmacy prescription refill frequency. Results Of the 130 patients who completed a test dose of TIP (median 25.5 yrs, FEV 1 68% predicted), 58 patients (45%) continued to be prescribed TIP (median 29 months). In those discontinuing TIP (n = 72), the most common causes of discontinuation were ‘cough' (n = 17) and ‘tight chest' (n = 13). At test dose, the patients who subsequently discontinued TIP were older (median 27 yrs vs. 24 yrs), had lower FEV 1 (median 57% vs. 74%) and more frequently reported adverse events (AEs) (median 36% vs. 14%). Of the 72 patients who discontinued TIP, 56% were also intolerant of TIS. Prescription refill frequency in patients who have continued TIP was 65%. Conclusion ‘Real-world' tolerance to TIP in the longer term appears to be a significant challenge. Age, FEV 1 and AEs reported at trial may help to predict longer-term intolerance. In those continuing TIP, prescription refill frequency of 65% suggests that longer-term adherence was relatively well maintained.