Introduction Vascular catastrophes and inflammatory bowel disease (IBD) are underlying conditions for massive intestinal resection and failure associated with short bowel syndrome (SBS-IF). This post hoc analysis reports the baseline characteristics and clinical response of patients diagnosed with SBS-IF due to vascular catastrophes (SBS-Vasc), IBD (SBS-IBD), or Other.
Method STEPS (NCT00798967; EudraCT 2008-006193-15) was a 24 week, placebo-controlled study of teduglutide (TED) 0.05 mg/kg/day in patients with SBS-IF. The change from baseline in mean (SD) parenteral support (PS) volume reduction was the measure of clinical response. Vascular catastrophes were intestinal ischemia or mesenteric vessel thrombi or emboli. Patients with Crohn’s disease were in clinical remission for ≥12 weeks at baseline. Descriptive summary statistics are presented with SDs; this post hoc analysis was not powered for statistical significance.
Results The analysis included 32 pts with SBS–Vasc, 19 pts with SBS–IBD and 34 pts with SBS–IF due to other aetiology. Patients with SBS-Vasc were less likely to have stoma presence, had lower PS requirements, and were more likely to have colon-in-continuity at baseline. In contrast, patients with SBS-IBD had evidence of more severe disease (eg, higher frequency of stoma presence, higher PS requirements, and lower colon-in-continuity). In TED patients, reduction in mean (SD) PS volume (change in L/week, percentage change) took longer to be realised in SBS-Vasc patients (Week 12: −1.9 [2.8], −12% [14.2%]; Week 24: −3.6 [3.8], −25% [18.4%]) compared with the SBS-IBD (Week 12: −5.8 [4.3], −34% [17.8%]; Week 24: −7.7 [4.6], −45% [18.3%]) or Other (Week 12: −2.2 [1.6], −22% [15.5%]; Week 24: −3.2 [2.0], −32% [16.4%]) patients. PS reduction of ≥2 days per week was achieved by 3/15 (20%), 2/9 (22%), and 3/15 (20%) patients in the SBS-Vasc, SBS-IBD, and Other subgroups, respectively. Among patients receiving TED, TEAEs were reported by 80% with SBS-Vasc, 100% with SBS-IBD, and 75% with Other diagnoses. The most common TEAEs were abdominal pain, nausea, and peripheral oedema in SBS-Vasc patients (20.0% for all); nausea in SBS-IBD patients (54.5%); and abdominal pain in Other patients (37.5%).
Conclusion Baseline characteristics did not generally affect clinical response; however, patients with SBS-IBD appeared to respond fastest to TED in the observed PS volume reduction.
Disclosure of Interest PB Jeppesen Conflict with: Shire, Conflict with: Shire, K Iyer Conflict with: Shire-NPS, Conflict with: Zealand Pharmaceuticals, U.-F. Pape Conflict with: Shire-NPS, Conflict with: Shire-NPS, K Iqbal Conflict with: Shire, Conflict with: Shire, H.-M. Lee Conflict with: Shire, Conflict with: Shire, C Olivier Conflict with: Shire, Conflict with: Shire
- Inflammatory bowel disease
- short bowel syndrome
- vascular catastrophes