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 is the first and only long-term therapy indicated for the treatment of patients with SBS-IF.1,8,9
of patients achieved at least a 20% reduction from baseline in weekly PN/IV volume1,8
achieved complete, independence from PN/IV8
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
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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