Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure

Kristina Chen, Fan Mu, Jipan Xie, Sneha S Kelkar, Clément Olivier, James Signorovitch, Palle B Jeppesen, Kristina Chen, Fan Mu, Jipan Xie, Sneha S Kelkar, Clément Olivier, James Signorovitch, Palle B Jeppesen

Abstract

Background: Teduglutide reduces or eliminates parenteral support (PS) dependency in patients with short bowel syndrome (SBS). Recent post hoc analyses demonstrated that effects are correlated with baseline PS volume. We assessed the SBS-related quality-of-life (QoL) impact of teduglutide, particularly whether improvements are greater among subgroups achieving more PS volume reduction.

Methods: Using phase 3 trial data of teduglutide in patients with SBS (NCT00798967), change in Short Bowel Syndrome-Quality of Life (SBS-QoL) scores from baseline were compared between teduglutide vs placebo in the overall population and subgroups classified by baseline PS volume requirement, disease etiology, and bowel anatomy. Generalized estimating equation models were fitted to assess impact of teduglutide on SBS-related QoL using data from all visits, adjusted for baseline characteristics.

Results: Of 86 patients, 43 each were randomized to teduglutide or placebo (mean age: 51 vs 50 years, respectively). In adjusted analyses, teduglutide had a nonsignificant reduction (improvement) of -8.6 points (95% CI: 2.6 to -19.8) in SBS-QoL sum score from baseline to Week-24 vs placebo. The impact of teduglutide varied by subgroup. Patients treated with teduglutide experienced significantly greater reductions in SBS-QoL sum score at Week-24 vs placebo in 2 subgroups, ie, the third (highest) tertile baseline PS volume (-27.3, 95% CI: -50.8 to -3.7) and inflammatory bowel disease (IBD; -29.6, 95% CI: -46.3 to -12.9). Results were similar for SBS-QoL subscale and item scores.

Conclusions: The impact of teduglutide treatment on SBS-related QoL vs placebo varied among subgroups and was significant and most pronounced among patients with highest baseline PS volume requirement or IBD.

Keywords: intestinal failure; parenteral nutrition; quality of life; short bowel syndrome; teduglutide.

© 2019 The Authors. Journal of Parenteral and Enteral Nutrition published by Wiley Periodicals, Inc. on behalf of American Society for Parenteral and Enteral Nutrition.

Figures

Figure 1
Figure 1
Impact of teduglutide on SBS‐QoL sum score among patients stratified by baseline PS volume tertile in the ITT population. Adjusted changes in SBS‐QoL sum score from baseline were estimated using generalized estimating equation models, adjusting for baseline characteristics. Observations from all follow‐up visits were included in the analysis. *Statistically significant at P < 0.05. ITT, intent‐to‐treat; N, number of patients; obs n, number of observations; PS, parenteral support; SBS‐QoL, Short Bowel Syndrome–Quality of Life scale.
Figure 2
Figure 2
Impact of teduglutide on SBS‐QoL sum score among patients stratified by etiology classification in the ITT population. Adjusted changes in SBS‐QoL sum score from baseline were estimated using generalized estimating equation models, adjusting for baseline characteristics. Observations from all follow‐up visits were included in the analysis. *Statistically significant at P < 0.05. IBD, inflammatory bowel disease; ITT, intent‐to‐treat; N, number of patients; obs n, number of observations; SBS‐QoL, Short Bowel Syndrome–Quality of Life scale; VD, vascular disease.
Figure 3
Figure 3
Impact of teduglutide on SBS‐QoL sum score among patients stratified by anatomical classification in the ITT population. Adjusted changes in SBS‐QoL sum score from baseline were estimated using generalized estimating equation models, adjusting for baseline characteristics. Observations from all follow‐up visits were included in the analysis. *Statistically significant at P < 0.05. ITT, intent‐to‐treat; N, number of patients; obs n, number of observations; SBS‐QoL, Short Bowel Syndrome–Quality of Life scale.

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