What if you could free your patients with short bowel syndrome-intestinal failure (SBS-IF) from parenteral nutrition/IV fluids?

It may be possible with Revestive¹

Short bowel syndrome – intestinal failure

Short bowel syndrome-intestinal failure (SBS-IF) is a chronic, highly debilitating and potentially life-threatening malabsorption disorder.^2,3

While the true prevalence of SBS-IF worldwide is unknown, in Europe it is estimated that as many as 6 in 1 million people are affected.⁴

SBS-IF is defined as the reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and/or growth.⁵

Long-term parenteral nutrition/IV fluids (PN/IV) is associated with severe complications and can impact important elements of quality of life.^6,7

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Revestive

Revestive is the first and only long-term therapy indicated for the treatment of patients with SBS-IF.^1,8,9

• In adults with SBS-IF, during a long-term clinical study of Revestive, a significant proportion of patients achieved significant reductions in PN/IV with some achieving complete independence.¹

• In children with SBS-IF, Revestive reduced PN/IV requirements^1,11

Revestive: Indication

Revestive 5 mg powder and solvent for solution for injection is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery. The recommended dose of Revestive for adults and for children aged 1 year and above is 0.05 mg/kg body weight once daily.¹

* The primary efficacy endpoint was based on clinical response, defined as a subject achieving at least 20% reduction in weekly PN/IV volume from baseline (immediately before randomisation) at both weeks 20 and 24. Please note that in the Revestive clinical trials, the mean absolute reduction of PN/IV volume from baseline was significantly higher in the teduglutide group vs placebo at 8 weeks following initiation of treatment. However, individual response may vary as it depends on distinct patient characteristics (eg, remnant bowel anatomy). 

** Post-hoc analysis of study completers. Please note the efficacy in this study was based on the intent-to-treat population. Further randomised, controlled studies are necessary to corroborate these findings. Of the 37 Revestive subjects in STEPS, 30 completed 24 months of further treatment with Revestive in STEPS-2 (the Revestive/Revestive group). Of the 39 placebo subjects in STEPS, 29 completed 24 months of treatment with Revestive. At the end of study, 14 (48.3%), 7 (24.1%), and 5 (17.2%) patients achieved a reduction of 1, 2 or 3 days per week in PN/IV, respectively. Two subjects were weaned off their PN/IV while on Revestive. Of the 12 subjects not randomised in the pivotal study, 6 completed 24 months of treatment with Revestive. At the end of study, 3 (50%), 2 (33%), and 2 (33%) achieved a reduction of 1, 2, or 3 days per week in PN/IV, respectively. Two subjects were weaned off their PN/IV while on Revestive. 

*** Children with SBS-IF aged 1 – 17 (<18) years, all patients were unable to reduce their PN/IV dependence for at least 3 months prior to study entry; weight normalised reduction. 

† All patients were unable to reduce their dependence on PN/IV for at least 3 months prior to the study. Standard deviation for Revestive: -1.3±2. 6.6 days/week baseline PN/IV requirement for Revestive study population, 6.6 days/week baseline PN/IV requirement for SOC study population. 

PN/IV= parenteral nutrition/intravenous fluids; SBS-IF= short bowel syndrome – intestinal failure 

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References

1. Revestive (teduglutide) Summary of Product Characteristics (SmPC). October 2021.
2. Jeppesen PB. Spectrum of short bowel syndrome in adults: intestinal insufficiency to intestinal failure. JPEN J Parenter Enteral Nutr. 2014;38(1 Suppl):8S-13S.
3. Seidner DL, Schwartz LK, Winkler MF, et al. JPEN J Parenter Enteral Nutr. 2013;37:201-211.
4. Kelly DG, Tappenden KA, Winkler MF. Short bowel syndrome: highlights of patient management, quality of life, and survival. JPEN J Parenter Enteral Nutr. 2014;38:427-437.
5. Pironi L, Arends J, Bozzetti F, et al. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016;35:247-307.
6. Hofstetter S, Stern L, Willet J. Key issues in addressing the clinical and humanistic burden of short bowel syndrome in the US. Curr Med Res Opin. 2013;29:495-504.
7. Huisman-de Waal G, Schoonhoven L, Jansen J, et al. The impact of home parenteral nutrition on daily life-a review. Clin Nutr. 2007;26:275-288.
8. Schwartz LK, O’Keefe SJD, Fujioka K, et al. Long-term safety and efficacy of teduglutide for the treatment of intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016;7:e142.
9. Shire Press Release. 2016
10. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143:1473-1481.
11. Kocoshis SA, Merritt RJ, Hill S, et al. Safety and Efficacy of Teduglutide in Pediatric patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr.2020;44(4):621-631.