2017 - CIRTA
9- Intestinal Failure
48.3 - Impact of teduglutide and parenteral nutrition (PN) volume reduction on quality of life (QoL) in patients with short bowel syndrome and PN dependency
Presenter: Palle, Jeppesen, Coppenhagen, Denmark
Authors: Palle Jeppesen, Kristina Chen, Fan Mu, Jipan Xie, Sneha Kelkar, Clément Olivier, James Signorovitch
Impact of teduglutide and parenteral nutrition (PN) volume reduction on quality of life (QoL) in patients with short bowel syndrome and PN dependency
Palle Jeppesen1, Kristina Chen2, Fan Mu3, Jipan Xie4, Sneha S. Kelkar5, Clément Olivier6, James Signorovitch3.
1Rigshospitalet, Copenhagen, Denmark; 2Shire Human Genetic Therapies, Inc., Lexington, MA, United States; 3Analysis Group, Boston, MA, United States; 4Analysis Group, Los Angeles, CA, United States; 5Analysis Group, New York, NY, United States; 6Shire International GmbH, Zug, Switzerland
The impact of teduglutide (TED) and PN volume reduction on QoL in SBS PN-dependent patients (pts) and a pt subgroup with inflammatory bowel disease (IBD) was assessed. This is a post hoc analysis of a double-blind, placebo (PBO)–controlled, phase III (NCT00798967) and associated open-label extension study (NCT00930644). 86 randomized pts received TED (n=43) or PBO (n=43) for 24 weeks and could receive TED for up to 24 months (extension). SBS-related QoL was measured using SBS-QoL sum score change from baseline; a negative score indicates improvement. The TED impact on SBS-QoL was assessed using a GEE model including treatment variable, study visit, and interaction terms between treatment and study visit, adjusting for demographic and clinical characteristics. GEE was also used to evaluate the association between PN volume reduction and SBS-QoL scores adjusting for demographic and clinical characteristics. In the overall study population, mean reduction from baseline in SBS-QoL score at week 24 was 8.4 greater in TED vs PBO pts (indicating improvement with TED vs PBO, P=0.133). Compared to <20% PN volume reduction from baseline, a PN volume reduction ≥20% was significantly associated with SBS-QoL score improvement (-5.2 pts, P=0.017). The majority of PN volume reduction categories were associated with significant improvements vs <20% PN volume reduction; 20-<40%, 40-<60%, 60-<80%, 80-<100% and 100% PN reductions were associated with 5.6, 3.8, 1.4, 18.9 and 8.9 pts reduction in SBS-QoL score (P=0.027, 0.174, 0.774, 0.007, and 0.046). Similar results were observed for the IBD grp but with stronger associations; TED was significantly associated with SBS-QoL score improvement (–18.9 pts, P<0.001) vs PBO. Compared to <20% PN volume reduction in the IBD grp, a PN volume reduction ≥20% was significantly associated with SBS-QoL sum improvement (-10.6 pts, P=0.01); 20-<40%, 40-<60%, 60-<80%, 80-<100% and 100% PN reductions were associated with 8.2, 16.3, 10.3, 40.4 and 12.9 pts reduction in SBS-QoL score (P=0.080, 0.060, 0.448, 0.002, and 0.033). PN volume reduction was significantly associated with improvements in SBS-related QoL in the overall population and in a grp of pts with IBD. The strongest association was observed with 80-<100% PN volume reduction. Although TED did not significantly improve SBS-QoL scores in the overall population, TED was associated with PN volume reductions. In the IBD grp, TED was significantly associated with SBS-QoL score improvement.
Shire Human Genetic Therapies, Inc., Lexington, MA, USA.
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