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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


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

At 6 months, 63% of Revestive-treated patients achieved at least a 20% reduction from baseline in weekly PN/IV volume
(n=43 patients)*1,10

  • vs. 30% with placebo, p=0.002

Response to Revestive was sustained for over 2 years in patients completing 30 months of treatment
(post-hoc analysis, n=30 patients)**

of patients achieved at least a 20% reduction from baseline in weekly PN/IV volume1,8

achieved complete, independence from PN/IV8

  • In children with SBS-IF, Revestive reduced PN/IV requirements1,11

REDUCED PN/IV VOLUME REQUIREMENTS***1,11

At 24 weeks, 69% of patients treated with Revestive at the approved dose (0.05 mg/kg/day) achieved at least a 20% reduction from baseline in weekly PN/IV volume (n=26 patients)1,11

  • vs 11% with standard of care***

REDUCED THE NUMBER OF DAYS/WEEK ON PN/IV†1,11

  • Mean reduction in PN/IV by 1.3 days/week†1,11

GAVE COMPLETE FREEDOM FROM PN/IV7,8

  • As early as Week 24, 3/26 children treated with Revestive were independent from PN/IV1,11
    – vs. 0 with standard of care

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 


References

  1. Revestive (teduglutide) Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited, Dublin, Ireland. November 2017.
  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. 2019. Epub ahead of print.
 
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